Boston Scientific Regulatory Affairs Specialist III 

United States, Massachusetts, Marlborough 

410692637

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.