Senior Quality Engineer

The Senior Manufacturing Quality Engineer is a key member of our innovative team working on cutting-edge technologies in the field of cardiology. The primary responsibility of this role is to ensure the design assurance of a heart valve and a delivery catheter system. This position requires a background in the medical device industry, particularly in cardiological devices, including implantable heart valves and transcatheter delivery systems, along with a strong understanding of regulations and standards such as 21 CFR 820.

• Lead the product development process including key design assurance activities, design reviews, verification and validation activities, development and validation of testing methods, management of product requirements, test case tracing, and risk management.
• Facilitate the transition of new product development into production.
• Conduct reviews and enhancements of Quality Management System (QMS) processes related to design controls and design assurance activities.
• Gather, analyze, and present data using statistical tools and other analytical methodologies.
• Engage actively with team members, contributing to discussions with strong verbal and written communication skills.
• Demonstrate adaptability for rapid iteration and flexibility in design and strategy changes.

• Minimum of a Bachelor's degree in a technical field or equivalent professional experience.
• 8 years of experience in the medical device industry with 3 to 5 years in Quality.
• Deep understanding of CE Marking, EU MDR, FDA Medical Device Regulation (MDR), and FDA requirements.
• Extensive knowledge of manufacturing processes and practices relevant to the company's products.
• Proficiency in Microsoft Office applications including Excel, Word, and Outlook.
• Ability to work collaboratively across all organizational levels.
• Strong leadership skills to manage subordinates, projects, and workflow effectively.

• Meticulous attention to detail, strong analytical skills, and robust problem-solving capabilities.
• Superior communication skills and the capacity to collaborate effectively within a team setting.
• Experience in CAPAS functions, risk management, verification, and validation aligned with industry standards.
• Knowledge in statistics, data collection, analysis, and presentation techniques.
• Ability to handle confidential and sensitive information with professionalism.
• Exhibits exceptional organizational skills and the ability to prioritize multiple tasks.

The position is based on-site in Maple Grove, MN, within a small culture-oriented team that values collaboration and innovation. The work environment is dynamic and fast-paced, requiring multitasking and adaptability to evolving needs.

This is a Permanent position based out of Maple Grove, MN.

The pay range for this position is $90000.00 - $125000.00/yr.

Medical, dental, vision plans which are effective on your hire date. Health Care Savings Account (HSA) Employee Stock Ownership Program (ESOP) Company Paid Long-Term Disability (LTD) Paid Parental Leave Paid Bereavement Leave Paid Time Off Paid Holidays Employee Assistance Program

This is a fully onsite position in Maple Grove,MN.

This position is anticipated to close on Dec 19, 2025.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.

Salary : $90,000 - $125,000