דרושים Reliability Engineer ב-United States, California, 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.