Senior Quality Manufacturing Engineer

Job Title:

Sr. Manufacturing Quality Engineer Job Description The Sr. Manufacturing Quality Engineer is a vital member of an innovative team working on advanced technologies in the field of cardiology. The main responsibility of this role is to ensure design assurance for a heart valve and a delivery catheter system. Responsibilities 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, design assurance activities, and compliance requirements. 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. Adapt rapidly and flexibly to design and strategy changes. Essential Skills Experience in the medical device industry, particularly with cardiological devices, including implantable heart valves and transcatheter delivery systems. Strong understanding of regulations and standards such as 21 CFR 820. Meticulous attention to detail, strong analytical skills, and robust problem-solving capabilities. Superior communication skills and the ability to collaborate effectively within a team. Experience in CAPAs, risk management, verification and validation, and quality management systems. Additional Skills & Qualifications 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. Capability to multitask in a dynamic, fast-paced work environment. Ability to work collaboratively across all organizational levels. Strong leadership skills to manage subordinates, projects, and workflow. Exceptional organizational skills and the ability to prioritize multiple tasks. Ability to handle confidential and sensitive information professionally. Knowledge in statistics, data collection, analysis, and presentation techniques. Excellent interpersonal, communication, and problem-solving skills. Ability to work autonomously with minimal supervision and proactively seek guidance when necessary. Work Environment This position is based on-site in Maple Grove, MN. The role is part of a small, culture-oriented team with exciting innovations ahead. Job Type & Location This is a Permanent position based out of Maple Grove, MN. Pay and Benefits 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 Workplace Type This is a fully onsite position in Maple Grove,MN. Application Deadline This position is anticipated to close on May 13, 2026. Diversity, Equity & Inclusion At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I is embedded into our culture through: Hiring diverse talent Maintaining an inclusive environment through persistent self-reflection Building a culture of care, engagement, and recognition with clear outcomes Ensuring growth opportunities for our people Actalent is an equal opportunity employer. About Actalent Actalent is a global leader in engineering and sciences services. For more than 40 years, we've helped visionary companies advance their goals. Headquartered in the United States, our teams span 150 offices across North America, EMEA, and APAC—with four delivery centers in India led by 1,000+ extraordinary employees who connect their passion with purpose every day. Our Bangalore, Hyderabad, Pune, and Chennai delivery centers are hubs of engineering expertise, with core capabilities in mechanical and electrical engineering, systems and software, and manufacturing engineering. Our teams deliver work across multiple industries including transportation, consumer and industrial products, and life sciences. We serve more than 4,500 clients, including many Fortune 500 brands. Learn more about how we can work together at actalentservices.com.