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Principal Software Design Assurance Engineer - Axonics Integration
- Marlborough, Massachusetts, United States
- Marlborough, Massachusetts, United States
Über
Company: Boston Scientific. Division: Urology. Position: Principal Software Design Assurance Engineer – Axonics Integration.
Overview This role supports a cross‑functional team in the development and maintenance of implantable and external devices and software within the Urology division. The Engineer applies design controls supporting the software development lifecycle (SDLC), software verification and validation (V & V), risk management, product development, regulatory compliance, and standards compliance. The role maintains a collaborative partnership with cross‑functional team members to protect patient/user safety and meet business needs, supporting the active implantable design process for both existing and new products.
Work Arrangement This position follows a hybrid work model requiring presence in the local office at least three days per week. The role is available at Arden Hills, Maple Grove, Minnetonka, MN; Marlborough, MA; or Irvine, CA.
Relocation assistance is available. This position is not eligible for employment visa sponsorship.
Responsibilities
Participate in the implementation of new product software, including risk management (ISO 14971), hazard analysis, software FMEAs, security risk analysis, and software design V & V.
Apply software application development procedures and support compliance through technical documentation generation.
Have a thorough understanding of system and software design controls; attend cross‑functional team meetings and software bug triage meetings to discuss, investigate, and appropriately disposition internal software bugs and field issues.
Apply systematic problem‑solving methodologies to identify, prioritise, communicate and resolve quality issues (e.g., software bugs).
Work within a cross‑functional team to identify and implement effective controls and support product development from concept through commercialization.
Update and maintain software risk management tools (hazard analysis, FMEAs).
Participate in cybersecurity‑related discussions and assist supporting activities including Security Risk Analysis.
Lead and participate in software and electronic design reviews, design transfers, and all aspects of the Design Control process for the PCI Guidance products.
Act as an effective leader or team member in supporting quality disciplines, decisions, and practices.
Assist in the design and development of software test cases and inspection procedures.
Support regulatory submissions to notified bodies.
Demonstrate a primary commitment to patient safety and product quality by maintaining compliance with the Quality Policy and all other documented quality processes and procedures.
Qualifications
Bachelor’s degree in mechanical, electrical, computer or biomedical engineering (or related technical discipline).
Minimum 9 years of experience in design assurance, quality, new product development, or related medical device / regulated industry experience.
Understanding of Software Development Life Cycle (SDLC).
Experience with software testing and issue investigation/resolution.
Experience with issue‑tracking tools and requirements/test management tools.
Understanding of software configuration management (version control, Microsoft Office tools).
Adaptable and effective collaborator in a team environment and in self‑directed work.
Ability to work in a highly matrixed and geographically diverse business environment.
Demonstrated use of quality tools/methodologies.
Preferred Qualifications
Prior software design assurance experience.
Medical device or other regulated industry experience.
Strong knowledge of Quality System Regulation (QSR), risk‑management standards (ISO 14971) and software standards (IEC 62304 or IEC 82304).
Experience conducting and participating in code reviews.
Benefits & Compensation Estimated salary range: $106,800 – $202,900. Variable compensation may be provided, including annual bonuses and long‑term incentives. The total value of core and optional employee benefits will vary based on location.
Equal Opportunity Boston Scientific Corporation is an equal‑opportunity employer. The company will not discriminate on the basis of race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, gender expression, veteran status, age, mental or physical disability, genetic information or any other protected class.
COVID‑19 Vaccination & Prohibited Substance Test Some U.S. positions may require proof of COVID‑19 vaccination status. Candidates applying for safety‑sensitive positions must also pass a prohibited substance test.
Requisition ID: 630910
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Sprachkenntnisse
- English
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