Design Quality Engineer

Design Quality Engineer

The Design Quality Engineer leads design control efforts to develop new and improve existing medical devices. This role involves close collaboration with various functions, including R&D and Product Development core teams, to ensure appropriate design controls are established and achievable. Additionally, the position supports process development, manufacturing-related design changes, maintaining regulatory compliance, manufacturability improvements, and cost reduction efforts.

Responsibilities:

• Own the creation and implementation of all design control deliverables.
• Lead on-time Design Verification and Design Validation and support Process Validation IQ/OQ/PQ/PPQ planning and execution.
• Actively participate in and contribute to core team and customer-facing meetings.
• Drive the meaningful translation of user requirements into discrete, objective, measurable, verifiable, and traceable product requirements.
• Oversee risk management activities throughout the device life cycle, from product concept through post-launch.
• Create accurate and repeatable test and inspection methods.
• Support the creation and execution of biocompatibility and sterilization qualifications.
• Analyze data and prepare product test reports.
• Oversee the content of the Design History File, ensuring its completeness and integrity.
• Ensure component specifications are properly defined and evaluated through the creation of supplied component sampling plans, First Article Inspections, and supplier process qualifications.
• Support supplier management activities and external audits.
• Support external audit and certification efforts conducted by customers and regulatory bodies.
• Support manufacturing lines by resolving component issues or other manufacturing barriers in a timely manner.
• Oversee and approve document change requests, non-conformances, deviations, and special work order processes.
• Lead root cause analysis and resolution activities.

Essential Skills:

• 10+ years of experience in medical device quality engineering and design control.
• Strong background in risk management, particularly early-phase risk management (dFMEA).
• Proficiency in design verification and test method validation.
• Experience with IQ/OQ/PQ processes.
• Familiarity with ISO standards and root cause analysis.
• Experience in catheter-related projects.

Additional Skills & Qualifications:

• Electrical experience is a bonus but not required.
• Ability to manage and approve document change requests and resolve non-conformances.
• Strong analytical skills for data analysis and report preparation.

Job Type & Location:

This is a Contract to Hire position based out of Minneapolis, MN.

Pay and Benefits:

The pay range for this position is $58.00 - $72.00/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision • Critical Illness, Accident, and Hospital • 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available • Life Insurance (Voluntary Life & AD&D for the employee and dependents) • Short and long-term disability • Health Spending Account (HSA) • Transportation benefits • Employee Assistance Program • Time Off/Leave (PTO, Vacation or Sick Leave)

Workplace Type:

This is a fully onsite position in Minneapolis, MN.

Application Deadline:

This position is anticipated to close on Jan 23, 2026.