$90,000–$125,000 Per Year
Analysis Skills, Artificial Intelligence (AI), Candidate Screening, Cardiology, Catheterization, Code of Federal Regulations, Communication Skills, Data Analysis, Data Collection, Dental Insurance, Design Verification, Detail Oriented, Establish Priorities, FDA Requirements, Genetics, Implants, Interpersonal Skills, Leadership, Manufacturing, Manufacturing Engineering, Manufacturing/Industrial Processes, Maple, Medical Equipment, Microsoft Excel, Microsoft Office, Microsoft Outlook, Microsoft Word, Multitasking, Organizational Skills, Presentation/Verbal Skills, Problem Solving Skills, Product Development, Product Management, Quality Assurance Methodology, Quality Engineering, Quality Management, Regulations, Regulatory Compliance, Requirements Management, Risk Management, Statistics, Team Player, Test Case, Validation Testing, Vision Plan, Writing Skills
Senior Manufacturing Quality Engineer
Job Description
The Senior 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 29, 2026.
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 process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.
San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records.
Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.