דרושים Fellow Electrical Engineer ב-Boston Scientific ב-United States, Irvine

About the role:

Boston Scientific is looking for a Fellow Electrical Engineer. You will be responsible for providing electrical and electronic engineering support and expertise in the definition, design, development and test of products in accordance with the Quality system standards, Design Controls and customer requirements. Ensures products are designed to facilitate manufacturability.

Your responsibilities will include:

• May work with R&D leadership to define technical roadmaps aligned with business objectives.
• Drive continuous improvement in engineering processes and methodologies.
• Collaborate with Regulatory Affairs, Clinical, Quality and Manufacturing teams etc. throughout product lifecycle.
• Participate in executive reviews and strategic planning sessions.
• Maintains substantial knowledge of state-of-the-art principles and theories in their particular area of expertise.
• Provides critical design and technical problem resolution.
• Assume technical lead in the design, development, and testing of complex bioelectronic systems comprised of PCB design, stimulation, power management, wireless communication, and sensing technologies, etc.
• May lead projects or project teams with moderate resource requirements, risk, and/or complexity.
• Can work independently within functional / divisional policies while maintaining good communication with functional and cross-functional teams.
• May help with technical recruitment, training, and ongoing support of staff.
• Provides technical guidance, training and mentorship to less senior staff contributing to their ongoing development within the company.
• Provides feedback to the development staff on customer specific enhancements as well as new applications for base product in accordance with Quality System requirements.
• Ensures new products or product enhancements are designed to facilitate transfer to manufacturing in a timely fashion and in accordance with Quality System requirements. Facilitates the process of transferring products from development to manufacturing.
• Ensures that engineering testing and documentation is in accordance with regulatory requirements for approval of products by the regulatory agencies of the countries into which the products will be marketed.
• Works with patent attorneys in documenting innovative ideas, reviewing patent application, and supporting Freedom to Operate Analysis.
• Converts complex information to compelling business context and advice.
• Presents convincing arguments for complex ideas and projects at cross-functional meetings in a way that persuades others to agree on recommendation and/or approach, when appropriate.

Required qualification:

• Bachelor’s degree in engineering or related discipline or equivalent experience. Master’s degree or higher in engineering is preferred.
• 10+ years’ experience in medical device design or similar products.
• Experience working under and knowledge of quality systems designed to meet FDA/EU regulatory requirements.
• Experience and knowledge of pre-clinical testing of medical products.
• Ability to travel 20% of the time.

Preferred qualifications:

• Demonstrates strong proficiency in Electrical Engineering, especially in analog circuit design.
• Ability to adapt and learn quickly leveraging knowledge towards the contribution of projects.
• Ability to use Microsoft Office tools for documentation, analyzing data, presenting data or ideas, etc.
• Ability to use Microsoft Excel and other data analysis tools to manipulate and analyze data sets.
• Competence in the use of Electronics CAD software (Altium) for schematic capture and PCB layout is preferred.
• Professional, clear verbal and written communications skills required.
• Ability to work independently or in a team setting as required.

Maximum Salary: $ 243000

Compensation fornon-exempt (hourly), non-sales rolesmay also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements).

Compensation forexempt, non-sales rolesmay also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements).

For MA positions: It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability.

Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements. As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company’s policies or protocols change with regard to COVID-19 vaccination.

Among other requirements, Boston Scientific maintains specific prohibited substance test requirements for safety-sensitive positions. This role is deemed safety-sensitive and, as such, candidates will be subject to a prohibited substance test as a requirement. The goal of the prohibited substance testing is to increase workplace safety in compliance with the applicable law.

Your responsibilities will include:

• Assesses process capabilities, prioritizes process improvement opportunities, and innovates and implements process improvements on multiple and moderately complex processes. Represent the Product Assurance function within cross-functional product development teams, ensuring quality assurance, usability, and regulatory compliance throughout the product lifecycle.
• Contribute to software verification and validation by supporting the development of test strategies, applying relevant statistical techniques, and executing structured testing procedures.
• Design, develop, and execute test cases and test methods to verify system functionality and ensure business and user requirements are met; document results and author detailed test reports.
• Develop and maintain software development lifecycle (SDLC) documentation, traceability matrices, and design records to support regulatory submissions and internal quality management systems.
• Establish, implement, and maintain quality systems in accordance with FDA regulations, ISO 13485, IEC 62304, and other applicable international standards.
• Assist in internal and external audits to evaluate GMP and ISO compliance, support the identification of risks—including cybersecurity vulnerabilities, and contribute to recommending corrective actions that uphold product integrity and regulatory readiness.
• Collaborate closely with software development, hardware engineering, and other cross-functional teams; actively participate in scrum meetings, product reviews, and bug triage sessions.
• Possess strong knowledge of comprehensive risk management documentation, including Hazard Analysis, Task Analysis, and Design FMEAs, with familiarity in applying advanced risk mitigation strategies.
• Participate in design verification, validation, and usability testing activities, contributing to alignment with internal and external requirements.
• Support junior engineers by sharing technical insights related to product assurance, regulatory compliance, and software quality practices.
• Contribute to continuous improvement efforts by helping identify process gaps, refine tools and documentation, and promote quality-focused practices.

Required qualifications:

• Bachelor’s degree in Engineering, Science, or a related technical field
• Minimum of 2 years of experience in a Quality Assurance role, preferably within a regulated industry

Preferred qualifications:

• Medical device industry experience

Maximum Salary: $ 138300

Compensation fornon-exempt (hourly), non-sales rolesmay also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements).

Compensation forexempt, non-sales rolesmay also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements).

For MA positions: It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability.

Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements. As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company’s policies or protocols change with regard to COVID-19 vaccination.

Among other requirements, Boston Scientific maintains specific prohibited substance test requirements for safety-sensitive positions. This role is deemed safety-sensitive and, as such, candidates will be subject to a prohibited substance test as a requirement. The goal of the prohibited substance testing is to increase workplace safety in compliance with the applicable law.

About the role:

Responsible for providing technical acumen and leadership to the Irvine, CA Sacral Neuromodulation manufacturing site with a significant focus on production / operations quality. This will include support for in-process inspection, final inspection, final product release activities, and will lead investigation and resolution of nonconformances. This role will also support post-acquisition quality systems integration activities as well as product transfer projects.

Your responsibilities will include:

• Developing and implementing quality inspection procedures including sampling plans, for production level components, sub-assemblies and finished goods. May also be responsible for the development and implementation of inspection methodologies, fixtures, measurement systems and calibration of such.
• Providing input regarding appropriate statistical methods, test methodologies, test facilities and equipment. Coordination of testing and management of resulting documentation and records. This can include process validation, equipment installation/operational qualification, test method validation, etc.
• Conducting product and process nonconformance investigations and may include NCEP & CAPA ownership.
• Mentoring junior engineers and investigators by providing technical guidance in identifying and resolving quality issues using engineering essentials and other related problem-solving tools and techniques.
• Ensures compliance with company quality policies and practices by participating in product and material reviews, assist in resolving problems related to the Manufacture, test, validation, and documentation.
• Fostering a diverse and inclusive workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives.
• Demonstrating a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.

Required qualifications:

• Bachelor’s degree in Engineering or other related scientific discipline
• Minimum of 3 years of related experience
• Knowledgeable in Quality System Regulations, Medical Device Regulation, and ISO13485 Quality Standards.

Preferred qualifications:

• Experience in Medical Device industry
• Demonstrated effective change leadership and results-oriented focus
• Demonstrated problem-solving & data analysis capabilities
• Proficient with Microsoft Office tools including Word, Excel, PowerPoint, and Outlook.
• Strong business acumen and communication skills, with the ability to quickly establish impact and consequences
• Ability to collaborate and influence across multiple, cross-functional teams
• Strong ability to successfully multi-task and adaptability
• Demonstrated experience managing and leading multiple projects covering diverse engineering (i.e. Software, Hardware, Labeling) disciplines and functions.
• Knowledge of analytical techniques, problem solving, continuous improvement programs, and statistical analysis
• Self-starter with the ability to identify improvement opportunities.
• Comfort speaking to groups of individuals including divisional senior leaders. Presentation skills that comfortably and concisely translate performance and issues to peer and senior management audiences.

Maximum Salary: $ 164500

Compensation fornon-exempt (hourly), non-sales rolesmay also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements).

Compensation forexempt, non-sales rolesmay also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements).

For MA positions: It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability.

Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements. As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company’s policies or protocols change with regard to COVID-19 vaccination.

Among other requirements, Boston Scientific maintains specific prohibited substance test requirements for safety-sensitive positions. This role is deemed safety-sensitive and, as such, candidates will be subject to a prohibited substance test as a requirement. The goal of the prohibited substance testing is to increase workplace safety in compliance with the applicable law.

Work Mode:

This role follows an onsite work model, requiring employees to be in our Axonics office five days per week. The address of the office is 15515 Sand Canyon Ave, Irvine, CA 92618.

Your responsibilities will include:

• Responsible for the design of test fixtures, considering factors like reliability, throughput, test coverage, product tolerances, test parameters, and ease of use.
• Creates and maintains design documentation for test fixtures which include design requirements, assembly drawings, and bill of materials.
• Creates and maintains supporting documentation for test fixtures including assembly instructions, operation procedures, calibration procedures, installation and operation test protocols (IOQs), and test reports.
• Oversee the manufacturing of test fixtures, including working with vendors and technicians to ensure accurate construction and documentation.
• Helps in the calibration and maintenance of test fixtures to ensure on-going accuracy and reliability.
• Analyze test results, identify potential issues, and provide feedback to design teams for product improvement.
• Diagnose and resolve issues with test fixtures during operation.
• Performs risk management activities per company SOPs.
• Actively participates in design reviews of his/her own designs and others’ designs.
• Works as part of a project team, or on an individual basis to refine existing specifications, develop process improvements, validation testing and makes yield enhancements and cost reductions.
• Performs systems engineering and component engineering activities.
• Ensures documentation is in accordance with Quality System requirements.
• Assists designing, writing, and performing test protocols, and produces test reports.
• Leads or trains Assemblers and Technicians.

Required qualifications:

• BS in Electrical Engineering or a related scientific discipline.
• 2+ years of experience in electrical engineering.
• Experience in designing, maintaining, and qualifying test fixtures, preferably for medical devices.
• Experience working under regulated quality systems such as cGMP’s, ISO, and MDR.
• Ability and experience in using the following test equipment: DVM, oscilloscopes, and signal generators.

Preferred qualifications:

• Competence in the use of Electronics CAD software for schematic capture and PCB layout is preferred.
• Experience in or familiarity with manufacturing processes for medical devices is preferred.
• Engineering experience with Class II or III medical devices is preferred, though equivalent experience in other regulated environments is acceptable.
• Ability and patience to analyze, debug and troubleshoot electronic circuitry is preferred.

Maximum Salary: $ 138300

Compensation fornon-exempt (hourly), non-sales rolesmay also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements).

Compensation forexempt, non-sales rolesmay also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements).

For MA positions: It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability.

Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements. As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company’s policies or protocols change with regard to COVID-19 vaccination.

Among other requirements, Boston Scientific maintains specific prohibited substance test requirements for safety-sensitive positions. This role is deemed safety-sensitive and, as such, candidates will be subject to a prohibited substance test as a requirement. The goal of the prohibited substance testing is to increase workplace safety in compliance with the applicable law.

Your responsibilities will include:

• Clinical case coverage, and support sales and marketing initiatives.
• Train the surgical team to assist in good patient outcomes and verbally support cases.
• Acquire and maintain current knowledge of perioperative surgical technology practice and hospital and ASC policies and procedures.
• Develop technical acumen to serve as an educational and clinical resource.
• Demonstrate appropriate interactions with all healthcare providers.
• Maintain and prepare equipment/kits for surgery and quality control audits.
• Troubleshoot equipment according to standard procedure.
• Ensure accuracy of received and returned inventory matches with shipping documents.
• Reconciles inventory/usage as well as missing inventory.
• Assist in the delivery of procedural training with physicians and medical staff.
• Ensure compliance with all company policies, including the quality policy, on label promotion and interactions with healthcare professionals.
• Other duties may be assigned.
  

Required qualifications:

• Experience with procedures utilizing fluoroscopy, CT, MRI or X-rays / radiography is essential.
• High School Diploma or GED or associate degree with a minimum 4 years in a clinical specialist or related medical role, preferably in a medical device company; OR
• A bachelor’s degree with a minimum of 2 years in a clinical specialist or related medical role (Rad. Tech. / Surg. Tech., etc.), preferably in a medical device company.
• Customer relationship and procedural skill development experience.
• Reliable transportation, valid driver's license, and insurance is required.
• Travel is required.
• Must be able to walk, stand, sit, bend and lift to complete the basic functions of the role. The employee must occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job involve normal vision.

Preferred qualifications:

• Operating Room experience (exposure to surgery/surgical procedures)
• Spine or Pain Management experience.
• Strong verbal and written communication, and interpersonal skills.
• Ability to pivot and work in a fast-paced environment with a positive attitude.

The anticipated annualized base amount or range for this full time position will beplus variable compensation governed by the Sales Incentive Compensation Plan (which includes certain annual non-discretionary incentives based on predetermined objectives) as well as the value of core and optional benefits offered at BSC, which can be reviewed at www.bscbenefitsconnect.com. Actual compensation will be commensurate with demonstrable level of experience and training, pertinent education including licensure and certifications, and other relevant business or organizational needs.

For MA positions:It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability.

Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements. As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company’s policies or protocols change with regard to COVID-19 vaccination.

Among other requirements, Boston Scientific maintains specific prohibited substance testing requirements for safety-sensitive positions. This role is deemed safety-sensitive and, as such, candidates will be subject to a drug test as a pre-employment requirement. The goal of the drug testing is to increase workplace safety in compliance with the applicable law.

Your responsibilities will include:

• Participate in technology evaluations, specification development, and system integration of firmware for active implantable medical devices
• Support firmware architecture and embedded development, ensuring alignment with IEC 62304 and FDA regulations
• Identify potential risks, cybersecurity vulnerabilities, and integration challenges for acquired technologies
• Ensure compliance with FDA premarket cybersecurity guidance and IEC 62443 standards
• Collaborate with cross-functional teams including hardware, systems, risk management, regulatory, and clinical stakeholders
• Develop and maintain thorough documentation, traceability, and SDLC artifacts for regulatory submissions
• Participate in software and system risk management activities across the development lifecycle
• Develop and execute unit and integration tests, as well as design verification protocols
• Contribute to low-power embedded design, wireless communication (BLE, NFC, RF), and real-time OS integration
• Establish firmware development lifecycle processes in alignment with Boston Scientific’s QMS
• Conduct firmware testing, debugging, and verification using unit test frameworks and hardware-in-the-loop tools
• Support regulatory submissions (510(k), PMA, CE Mark) involving firmware changes
• Assist in the transfer of product designs from R&D to manufacturing
• Foster innovation and promote knowledge sharing within the R&D engineering team

Required qualifications:

• Bachelor’s degree or higher in Computer Science, Computer Engineering, Electrical Engineering, or related field
• 4+ years of experience in embedded firmware development
• 2+ years of experience with implantable, wearable, or IoT medical devices
• Proficiency in C/C++ for microcontroller-based firmware
• Strong knowledge of low-power embedded systems and RTOS development
• Experience with firmware risk assessment, cybersecurity, and regulatory compliance
• Skilled in using oscilloscopes, logic analyzers, and related test equipment
• Experience integrating BLE firmware with mobile (iOS/Android) and desktop (Windows) applications
• Familiarity with Microsoft Visual Studio and C#.Net
• Demonstrated communication, documentation, and organizational skills
  

Preferred qualifications:

• Working knowledge of ISO 13485, ISO 14971, and FDA QSR requirements
• Experience in M&A due diligence within the medical device sector
• Hands-on experience with secure bootloaders, cryptography, and OTA firmware updates
• Advanced BLE expertise, including pairing, security, GATT profiles, and custom services
• Experience with BLE stacks (e.g., Nordic, On Semi) and optimizing for low-power performance

Maximum Salary: $ 164500

Compensation fornon-exempt (hourly), non-sales rolesmay also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements).

Compensation forexempt, non-sales rolesmay also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements).

For MA positions: It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability.

Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements. As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company’s policies or protocols change with regard to COVID-19 vaccination.

Among other requirements, Boston Scientific maintains specific prohibited substance test requirements for safety-sensitive positions. This role is deemed safety-sensitive and, as such, candidates will be subject to a prohibited substance test as a requirement. The goal of the prohibited substance testing is to increase workplace safety in compliance with the applicable law.

About the role:

Responsible for providing electrical engineering support and expertise in the definition, design, development and test of complex implantable medical devices.

Your responsibilities will include:

• Designs, develops, debugs, modifies, and tests electrical circuits and systems by using current tools, analysis techniques, and technologies.
• Documents electrical development by writing documents, reports, memos, change requests. Methods used are determined by approved procedures and standards.
• Tracks electrical development effort by creating and maintaining records in the approved tracking management tool to include, utilizing multiple version control, defect tracking, and peer review tools including Accurev, JIRA and Windchill.
• Solves engineering problems by analyzing the situation and recommending corrective or alternative actions.
• Analyzes, evaluates, verifies, requirements, circuits, and systems by using engineering practices.
• Investigates, researches, selects electronic circuits, components, tools, equipment and practices.
• Ability to perform design analysis and exploratory testing.
• Ability to work with electrical and mechanical hardware and associated tools and infrastructure.
• Able to write final evaluation reports and work with regulatory group to satisfy the requirements for external regulatory agencies.
• Establishes and promotes a work environment that supports the Quality Policy and Quality System. Demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.
• Solves a range of problems of varying scope and complexity, generally applying existing solutions, while exercising autonomy to propose alternatives understanding their impact on the business or apply judgment based on experience to develop new solutions.
• Works independently guided by company policies, guidelines and procedures, receiving guidance on complex and unprecedented problems.

Required qualifications:

• Bachelor’s degree with 5+ years of work experience, or a master’s degree with 3+ years of work experience in Electrical Engineering.
• Ability to collect, organize, synthesize, and analyze data; summarize findings; develop conclusions and recommendations from all stakeholders using all sources of data.
• Ability to analyze test results and perform risk analysis.
• Ability to interpret and research requirements, specifications, and input/output processes.
• Experience with change management and issue tracking tools such as JIRA, AccuRev, Windchill etc.
• Requires in-depth conceptual, practical and technical and/or functional knowledge of principles and theories of board level electrical engineering and general understanding of related job functions.

Preferred qualifications:

• 3+ years of experience in hardware engineering.
• 3+ years’ experience automated and manual testing in regulated industry, preferably in active implantable medical device domain.
• 2+ year experience in system development lifecycle process including formalized processes and procedures.
• Create test protocols and automate tests using Python and other relevant tools.
• Create protocols, automate tests, general experience in Perl, Python, HTML, scripting or equivalent.

Maximum Salary: $ 156900

Compensation fornon-exempt (hourly), non-sales rolesmay also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements).

Compensation forexempt, non-sales rolesmay also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements).

For MA positions: It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability.

Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements. As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company’s policies or protocols change with regard to COVID-19 vaccination.

Among other requirements, Boston Scientific maintains specific prohibited substance test requirements for safety-sensitive positions. This role is deemed safety-sensitive and, as such, candidates will be subject to a prohibited substance test as a requirement. The goal of the prohibited substance testing is to increase workplace safety in compliance with the applicable law.