Job Title: Engineer - Quality Engineer II
Location: Maple Grove MN 55311
Duration: 12+ Months
Job Description: Hybrid - 3 days onsite in MG.
Possible travel between MG & AH, on occasion.
Job Purpose:
- The Design Assurance Engineer is a quality engineer that directly supports medical device product development from concept through commercialization.
- This role will work within high-performance, cross-functional teams to ensure the safety, quality, and compliance of commercialized products while continuously improving their value through end-of-life.
- Design Assurance drives the ISO 14971 risk management process and the Verification & Validation (V&V) process. This includes quality plans, risk management plans and reports, hazard analysis, product risk management workbook (user FMEA and design FMEA), sampling systems/procedures and statistical techniques, verification protocols/testing/reports, validation protocols/testing/reports.
- This role will be responsible for ensuring quality and compliance through product development and commercialization for medical electrical equipment/systems (MEE) within the Interventional Cardiology (IC) division.
- This person will be helping with the sustainment of CAPA work and solutions - on the development side.
Key responsibilities will include:
- Apply sound, systematic problem-solving methodologies to identify, prioritize, communicate, and resolve quality issues
- Act as an effective team member in supporting quality disciplines, decisions, and practices
- Work within a cross-functional team to identify and implement effective controls and support commercial design changes, specifically with regard to quality and risk management
- Support the verification, validation, and usability testing to meet or exceed internal and external requirements
- Perform regulatory standard assessments and support regulatory submissions to notified bodies
- Demonstrate good working knowledge and application of validation and statistical techniques in order to comply with associated regulatory requirements and internal standards
- Develop, update, and maintain Design History File and Design Input / Output documentation (Product Specification, Component Specifications, and Prints)
- Update and maintain product risk management tools (e.g., Hazard Analysis, Fault Tree, FMEAs)
What we’re looking for in you:
Minimum qualifications:
- Bachelor’s degree in biomedical, Mechanical, or Electrical Engineering, or related field of study
- Plus 2+ years of experience in design assurance, new product development, or related experience in a highly regulated industry
- Demonstrated use of Quality tools/methodologies
- Strong verbal and written communication skills
- Self-motivated with a passion for solving problems and a bias for action
- Effectively work and collaborate in a hybrid (onsite plus remote) environment
Preferred qualifications:
- Prior medical device industry experience, particularly with medical electrical equipment
- Working knowledge of US and International regulations including ISO 13485, ISO 14971, IEC 60601-1, EN 62366, and Quality System Regulations
- Experience in managing multiple projects across multiple organizational disciplines
Job Type: Contract
Schedule:
Application Question(s):
- Are we specifically Looking green card holders and citizens are eligible to work on a W2 basis? No C2C
- We are not looking C2C.
Education:
Experience:
- CAPA: 3 years (Preferred)
- Manufacturing Quality: 3 years (Required)
- Medical Device: 3 years (Preferred)
Work Location: On the road