Design Quality Engineer III — Medical Device (Hybrid — Maple Grove, MN) Con at Pharmavise Corporation

Maple Grove, Minnesota, United States -

Full Time

Start Date

Immediate

Expiry Date

19 Dec, 25

Salary

0.0

Posted On

20 Sep, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Design Quality, Design Assurance, Risk Management, Problem Solving, Regulatory Compliance, Manufacturability, Cost Reduction, Design Verification, Design Validation, Usability Protocols, Corrective Actions, Preventive Actions, Cross-Functional Collaboration, Medical Device Experience, Quality Systems, Design History File

Industry

Business Consulting and Services

Description

Job Summary: The Design Quality Engineer will support the application of design controls to projects focusing on design changes, material continuity, regulatory and standards compliance, corrective and preventive actions, and improvements for manufacturability and cost reduction. This individual will work with a cross-functional team to ensure safety, quality, and compliance of products. Imaging diagnostic catheter design changes Working with a team of 5 Design Assurance engineers Total team of 20 Key Responsibilities: • Ownership of design change projects including scoping, assessment, and implementation. • Develop, update, and maintain Design History File and Design Input / Output documentation • Develop, update and maintain risk management files, such as the Hazard Analysis, Task Analysis, and Design FMEA. • Develop and execute Design Verification, Design Validation, and Usability protocols and reports to meet or exceed internal and external requirements. • Provide design quality support in the resolution of PIRs, CAPAs, and NCEPs. • Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues. Quality Systems Duties and Responsibilities: Build Quality into all aspects of their work by maintaining compliance to all quality requirements. Qualifications: • Bachelor’s degree in an engineering discipline • Experience in design assurance, quality, or related medical device or regulated industry experience • 5 - 7 Years experience with BS, 3 - 5 Years with MS • Medical device experience preferred • Must have worked in a regulated space • Design quality experience • Design assurance experience • Risk management experience • Good problem-solving ability Other Details: • Schedule: 08:00 AM - 04:30 PM • Work Setup: Hybrid – Maple Grove, MN, will transition at the end of Oct to Arbor Lakes facility (1.5 miles away) • Contract Length: 12 Months (10/20/2025 - 10/20/2026)

Responsibilities

The Design Quality Engineer will own design change projects, ensuring compliance with design controls and quality requirements. They will work with a cross-functional team to enhance product safety, quality, and manufacturability.