Design Quality Engineer III

Design Quality Engineer III

Diversity - Innovation - Caring - Global Collaboration - Winning Spirit- High Performance At Boston Scientific, we'll give you the opportunity to harness all that's within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we'll help you in advancing your skills and career. Here, you'll be supported in progressing - whatever your ambitions.

About The Role

Boston Scientific Peripheral Interventions is seeking a Design Quality Engineer III to help advance our product portfolio. In this role, you will collaborate across functions to ensure device safety, quality, and regulatory compliance, delivering exceptional products to our customers. As a key member of the Quality team, you will support the design and development of a next-generation mechanical thrombectomy device within the AngioJet product family. You will apply robust quality engineering methodologies that align with Boston Scientific, customer, and regulatory standards.

At Boston Scientific, we value collaboration and synergy. This role follows a hybrid work model requiring employees to be in our Maple Grove office three days per week. Relocation assistance may be available for this position. Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position.

Your Responsibilities Will Include

• Be a part of 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.
• Supports departmental, functional, and divisional Design Quality goals and priorities.
• Executes methodologies to effectively meet individual and team objectives.
• Execute methodologies such as Statistical Analysis, Risk Management, and Root Cause Analysis in support of project activities.
• Ensure adherence to the quality systems and Design Assurance SOPs and Boston Scientific's Product Life Cycle Process (PLCP).
• Apply critical thinking and engineering analysis to solve problems.

What We're Looking For In You

Required Qualifications:

• Bachelor of Science in Mechanical / Biomedical Engineering or related discipline.
• 3+ years experience in design assurance or related field, or a combination of education and experience to perform at this level.
• Knowledge of key regulatory requirements, including ISO 14791 (Risk Management), 21 CFR 820 (US QS Regulation), ISO 13485 (Quality Management Systems).
• Ability to travel up to 10%.

Preferred Qualifications:

• Understanding of Quality tools and methodologies with an emphasis on Design Controls and Risk Management.
• Working knowledge and application of validation and statistical techniques to comply with associated regulatory requirements and internal standards.
• Strong technical knowledge, problem-solving abilities, collaborative mindset, and effective communication skills.
• Experience with Post Market Surveillance, EU MDR, and IEC 62366-1 (Usability).
• Ability to work independently and as part of a team.

Compensation will be commensurate with demonstrable level of experience and training, pertinent education including licensure and certifications, among other relevant business or organizational needs. At BSC, it is not typical for an individual to be hired near the bottom or top of the anticipated salary range listed above.

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 continue to 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.