Design Quality Engineer II

Design Quality Engineer II

Boston Scientific Urology division has an opportunity for a Design Quality Engineer II to join our prosthetic Urology team. This position supports a major product category with high visibility which will provide the right candidate with excellent growth potential and product development/sustaining experience. Design Quality Engineer II will work cross-functionally to ensure safety, performance, and compliance of our device while delivering the highest quality product to the customer. This role will serve as a Quality team member on New Product Development (NPD), Sustaining, and/or Integration projects and will utilize quality engineering methodologies and practices which meet BSC, customer, and regulatory requirements.

This hybrid role is based in Minnetonka, MN and requires being on-site at least three days per week. This position will start off at our Minnetonka, MN facility but will be transferred to our Weaver Lake campus Maple Grove, MN facility in 2026.

Your responsibilities will include:

• Be a part of an extended project team to identify and implement effective controls to support development or maintenance of products to meet internal and external requirements.
• Develops understanding of Design Controls, Risk Management and Usability for Medical Devices.
• Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
• Supports departmental, functional, and divisional design quality goals and priorities.
• Executes methodologies to effectively meet individual and team objectives.
• Utilizes methodologies such as Statistical Analysis, Risk Management, and Root Cause Analysis in support of project activities.
• Ensures adherence to the quality system Policies, SOPs, and work instructions following Boston Scientific's Product Life Cycle Process (PLCP).

Required qualifications:

• Bachelor of Science in Mechanical / Biomedical Engineering or related discipline in the sciences.
• Minimum of 2+ years experience in Design Quality Assurance, related experience in quality engineering or NPD design within a regulated industry.
• Understanding of Quality tools and methodologies with an emphasis on Design Controls, Root Cause Analysis and Risk Management.
• Strong communication skills (verbal & written)
• Ability to work independently and as part of a team.
• Comfortable with complaint data reviews and interpretation
• Ability to travel up to 10%.

Preferred qualifications:

• Experience with pharmaceutical or combination medical device development
• Working knowledge of key regulatory requirements, including ISO 14791 (Risk Management), 21 CFR 820, 210, 211 (US QS Regulation), ISO 13485 (Quality Management Systems), EU MDR, and IEC 62366-1 (Usability).
• Experience with medical device development for single use device
• Experience with Electronic Medical Equipment.

Compensation will be commensurate with demonstrable level of experience and training, pertinent education including licensure and certifications, among other relevant business or organizational needs.