Senior Design Assurance Engineer CRM

Additional Location(s): US-MN-Arden Hills

The Senior Design Assurance Engineer will directly support medical device product development from concept through commercialization and sustainment within the Cardiac Rhythm Management and Diagnostics (CRMDx) division. This role supports the Design Quality Assurance team in a variety of quality‑related activities on high‑visibility issues and projects impacting active implantable and accessory devices, as well as combination products with a drug component and overall product performance.

This is an on‑site role based in Arden Hills, Minnesota. Boston Scientific will not offer sponsorship or relocation assistance for this position.

• Apply sound, systematic problem‑solving methodologies to identify, prioritize, communicate and resolve quality issues.
• Act as an effective team member and mentor in supporting quality disciplines, decisions and practices.
• Support Design Assurance acquisition integration activities related to risk management remediation, Design Control Quality System integration and other Design Assurance integration priorities.
• Support verification, validation and usability testing activities to meet or exceed internal and external requirements.
• Develop, update and maintain Design History File and Design Input/Output documentation, including product specifications, component specifications and prints.
• Generate, update and maintain product risk management tools, including hazard analyses and FMEAs.
• Partner with Research and Development to determine and implement design controls based on risk management, customer needs and manufacturing input.
• Create, maintain and enhance cross‑functional team partnerships. Provide guidance regarding technical strategies and approaches while working across functions and multiple sites to identify and resolve technical issues.
• Perform additional duties as required.

• Minimum Bachelor’s degree with a minimum of 5 years’ experience, or Master’s degree with a minimum of 3 years’ experience, in design assurance, new product development or related medical device experience. Degree must be in an engineering discipline or related field of study.
• Understanding of ISO 13485, ISO 14971 and Quality System Regulations, with a focus on design controls and risk management.
• Demonstrated experience using quality tools and methodologies.
• Hands‑on experience and approach to product development.
• Willingness to travel up to 10%.

• Proven experience supporting quality integration activities.
• Boston Scientific experience preferred.
• Proven risk management and ISO 14971 experience.
• Proven experience with Class III medical devices, including electrical medical equipment or active implantable medical devices.
• Proven experience with products incorporating materials of animal origin.
• Proven experience with combination products that include a drug component.
• Proven ability to influence without direct authority.

Boston Scientific Corporation has been and will continue to be an equal opportunity employer. To ensure full implementation of its equal employment policy, the Company will take steps to assure that recruitment, hiring, assignment, promotion, compensation and all other personnel decisions are made and administered without regard to 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.

Candidates may be required to provide proof of COVID‑19 vaccination status, if applicable to the role.

This role is deemed safety‑sensitive and candidates will be subject to a prohibited substance test.