Senior Software Design Assurance Engineer

Senior Software Design Assurance Engineer

Onsite Location(s):
Arden Hills, MN, US 55112

Diversity - Innovation - Caring - Global Collaboration - Winning Spirit
- High Performance

We’re excited to offer a software-focused Senior Design Assurance Engineer to support a cross-functional team on development and maintenance of implantable and external devices and software within the Urology division. This position will support a significant product development project with high visibility, providing excellent growth potential and product development experience. The role will apply design controls throughout the software development lifecycle (SDLC), software verification and validation (V&V), risk management, regulatory and standards compliance, and ensure the protection of patient/user safety while meeting business needs.

The Design Quality role supports the active implantable design process for both existing and new products.

At Boston Scientific, we value collaboration and synergy. This role follows a hybrid work model requiring employees to be in our local office at least three days per week. In this position, you can work in Arden Hills, Maple Grove, or Minnetonka, MN, Marlborough, MA, or Irvine, CA.

Relocation assistance is available for this position.

Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position.

• Participate in the implementation of new product software, including risk management (per ISO 14971), hazard analysis, software FMEAs, security risk analysis, software design V&V.
• Apply software application development procedures and provide support to demonstrate compliance through technical documentation generation.
• Have a thorough understanding of system and software design controls, participate in cross‑functional team meetings, and software bug triage meetings to investigate and appropriately disposition internal software bugs and field issues.
• Apply systematic problem‑solving methodologies to identify, prioritize, 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 (e.g., Hazard Analysis, FMEAs).
• Participate in cybersecurity discussions and assist with 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.
• Serve 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 documented quality processes and procedures.

• Bachelor’s degree in engineering or a related discipline.
• A minimum of five 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.

• 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 in conducting and participating in code reviews.

Requisition

Minimum Salary: $82,600

Maximum Salary: $156,900

The anticipated…