Design Quality Engineer

Job Title: Design Quality Engineer Location: Sandy, UT (Onsite) Duration: 6–12 Months Experience Required: 6+ years

Job Description:

We're looking for a Design Quality Engineer who will lead and contribute to Design Verification, Sustaining Engineering, and New Product Development (NPD) projects. This role blends technical expertise with project leadership and requires hands-on engagement across the entire product lifecycle.

Key Responsibilities:

Lead Design Verification, Sustaining Engineering, and NPD projects using sound engineering practices and tools.

Act as the R&D representative in cross-functional teams, managing project tasks professionally and on time.

Build strong working relationships with internal stakeholders, consultants, and vendors to meet project goals.

Review project deliverables to ensure accuracy, completeness, and adherence to Good Documentation Practices (GDP).

Train teams on GDP, Good Laboratory Practices (GLP), IQ/OQ processes, calibration, and preventive maintenance.

Contribute to or create Design Verification protocols—advise on test methods, equipment selection, accuracy, sample sizes, and acceptance criteria.

Run weekly status meetings, track project progress, and manage self-utilization effectively.

Continuously seek improvement opportunities in test methods, processes, or tools that reduce cost or time, or improve quality.

Ensure timely completion and approval of documentation (memos, MSA, DV protocols/reports, IQ/OQ documents, etc.).

Maintain compliance with Quality System requirements through accurate documentation and adherence to procedures.

Collaborate cross-functionally based on project needs.

Support IP strategy by documenting unique, patentable experimental outcomes.

Take on additional tasks related to Sustaining Engineering or NPD as needed.

Required Education:

Bachelor’s degree or higher in Mechanical Engineering or related fields such as Mechatronics, Polymer Science, Biomedical, or Plastics Engineering.

Required Experience and Skills:

5–7 years in product development and design

2–3 years specifically in medical devices or regulated product development

Proven experience leading cross-functional teams in regulated environments

Strong grasp of quality systems, QMS processes, and regulatory compliance

Solid project or program management background

Excellent communication and leadership skills

Ability to influence and align stakeholders across teams

Experience managing technical documentation and product compliance