Senior Design Assurance Engineer - Axonics Integration

About the Role

This Senior Design Assurance Engineer will work on the Axonics Integration project, supporting product Design Control integration under the direction of the Design Control Workstream lead. The role ensures that during the integration of products and Design Control quality system processes, the product and processes remain safe, of high quality, and compliant with BSC and regulatory requirements. The Design Quality function supports the active implantable design process for both existing and new products.

The position follows a hybrid work model requiring presence in the local office at least three days per week, with possible locations in Arden Hills, Maple Grove, or Minnetonka, MN, Marlborough, MA, or Irvine, CA. Relocation assistance is available. Please note that Boston Scientific will not offer sponsorship for employment visas for this position.

• Apply systematic problem‑solving methodologies to identify, prioritize, communicate, and resolve quality issues.
• Act as an effective team member supporting quality disciplines, decision‑making, and practices.
• Work within a cross‑functional team to implement controls and support integration of design‑control related products, records, and processes.
• Write technical documentation for procedure execution, technical rationale, and evidence of the development process.
• Support Design Assurance activities related to Risk Management remediation, Design Control Quality System integration, and other related integration priorities.
• Support Post Market activities, as necessary, based on post‑market signals.
• Participate in the Design Change process to ensure proposed product changes are systematically analyzed and assessed.
• Demonstrate good working knowledge of validation and statistical techniques in compliance with regulatory and internal standards.
• Support verification, validation, and usability testing to meet or exceed internal and external requirements.
• Develop, update, and maintain Design History Files and Design Input/Output documentation (Product Specification, Component Specifications, and Prints).
• Generate, update, and maintain product risk‑management tools such as Hazard Analyses, Fault Trees, and FMEAs.
• Partner with R&D to determine and implement Design Controls based on Risk Management, Customer Needs, and Manufacturing Input.
• Partner cross‑functionally to identify and support value improvement efforts that align with business goals.

• Minimum of a bachelor’s degree in mechanical, electrical, biomedical engineering, or another related technical discipline.
• 5+ years of experience in design assurance, new product development, or related medical device/regulated industry experience.
• Self‑motivated with a passion for solving problems and a bias for action.
• Strong verbal and written communication skills.
• Demonstrated use of Quality tools and methodologies.
• Ability to effectively work and collaborate in a mixed onsite and remote environment.
• Experience creating detailed technical documentation.

• Experience working with medical electrical equipment and/or active implantables.
• Quality Integration experience.
• Knowledge of ISO 13485, ISO 14971, and Quality System Regulations with a focus on Design Controls and Risk Analysis.
• Experienced problem solver capable of facilitating the problem‑solving process.
• Adaptable and effective collaborator in a team environment or in self‑directed work.
• Experience with design changes, complaint reduction, and corrective action.

Requisition : 628585

Minimum Salary: $85,000

Maximum Salary: $161,500

Boston Scientific Corporation is an equal opportunity employer. All employment decisions are based on merit, without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, gender expression, veteran status, age, mental or physical disability, or genetic information. Candidates may be required to provide proof of COVID‑19 vaccination status and to submit to prohibited‑substance testing for safety‑sensitive positions.