Senior Design Assurance Engineer

Additional Location(s): N/A

This Senior Design Assurance Engineer will work on the Axonics Integration project, specifically supporting product Design Control integration under the direction of the Design Control Workstream lead. This position 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. This Design Quality role supports the active implantable design process for both existing and new products.

At Boston Scientific we value collaboration and synergy. The 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. Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position.

• Apply sound, systematic problem‑solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
• Acts as an effective team member in supporting quality disciplines, decisions, and practices.
• Works within a cross‑functional team to identify and implement effective controls and support integration of design control related products, records, and processes.
• Writes various technical documentation for procedure execution, technical rationale, and evidence of the development process.
• Supports Design Assurance activities related to Risk Management remediation, Design Control Quality System integration, and other DA related integration priorities.
• Supports Post Market activities, as necessary, of risk based on post‑market signals.
• Actively participates in the Design Change process to ensure the proposed changes to the products are systemically and thoroughly analyzed and assessed.
• Demonstrates good working knowledge and application of validation and statistical techniques in compliance with associated regulatory requirements and internal standards.
• Supports the verification, validation, and usability testing to meet or exceed internal and external requirements.
• Develops, updates, and maintains Design History File and Design Input / Output documentation (Product Specification, Component Specifications, and Prints).
• Generates, updates, and maintains product risk management tools (e.g., Hazard Analysis, Fault Tree, FMEAs).
• Partners with R&D to determine and implement Design Controls based on Risk Management, Customer Needs, and Manufacturing Input.
• Partners cross‑functionally to identify and support value improvement efforts to support business goals.

• Minimum of a bachelor's degree in mechanical, electrical, or biomedical engineering (or other 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 communication skills (verbal & written).
• Demonstrated use of Quality tools/methodologies.
• Ability to effectively work and collaborate in a mixed onsite + remote environment.
• Demonstrated experience creating detailed technical documents.

• Experience working with medical electrical equipment and/or active implantables.
• Quality Integration experience.
• ISO 13485, ISO 14971 and Quality System Regulations understanding 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.

Minimum Salary: $82,600
Maximum Salary: $156,900

The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) will vary based on actual location of the position and other pertinent factors considered in determining actual compensation for the role. Compensation will be…