דרושים Electrical Inspector 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.

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.

About the role:

Boston Scientific is looking for a Senior Principal/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.

About the role:

Our urology portfolio delivers comprehensive, clinically proven solutions that restore function and improve quality of life for patients worldwide. You’ll apply your expertise across all phases of product development, from concept through commercialization. As a key member of a cross-functional team, you will design, test, and troubleshoot electrical systems, driving innovation, enhancing product reliability, and upholding engineering excellence.

Your responsibilities will include:

• Design and analyze analog and digital circuitry for implantable medical systems
• Create and maintain engineering documentation, including requirements, schematics, assembly drawings, and BOMs
• Participate in risk management activities in accordance with company SOPs
• Lead and participate in design reviews—providing feedback on your own work and your peers’
• Troubleshoot and resolve issues in software-controlled analog and digital SMT circuit boards
• Perform component-level testing and analysis using tools such as oscilloscopes and DVMs
• Collaborate with cross-functional teams to refine specifications, improve processes, and optimize yield and cost
• Write and manage system and subsystem requirements through systems and component engineering
• Ensure all documentation complies with internal Quality System requirements
• Assist in the design, execution, and documentation of test protocols and reports
• Mentor and support Assemblers and Technicians in technical tasks

Required qualifications:

• Bachelor’s degree or higher in electrical engineering or a related field from an accredited institution
• Minimum of five years of experience in electrical engineering, with emphasis on product development or similar environments
• Experience with analog and digital circuit design, simulation, and analysis
• Ability to evaluate and select electrical components based on documented system requirements
• Experience operating standard electrical test instruments such as digital voltmeters, oscilloscopes, and signal generators, as well as using manual tools including soldering irons, crimpers, and screwdrivers
• Proficiency with electronic design software tools used for schematic capture and printed circuit board (PCB) layout review
• Ability to convey technical concepts clearly in both written documentation and verbal communication
• Ability to work independently, manage tasks, and collaborate effectively as part of a multidisciplinary team

Preferred qualifications:

• Hands-on experience with Altium Designer for schematic development, PCB layout, and fabrication documentation.
• Experience in a regulated industry, preferably with Class II or III medical devices
• Working knowledge of ISO 13485, ISO 14971, and FDA Quality System Regulations
• Familiarity with firmware development and embedded systems
• Background in systems engineering and requirements management
• Proven cross-functional collaboration across engineering, quality, and manufacturing disciplines
• Experience with radiofrequency (RF) design up to the low GHz range

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.