Design Quality Engineer

Job Description

As a Senior Design Quality Engineer, you will be responsible for leading the creation and implementation of all design control deliverables. You will play a key role in ensuring on-time design verification, validation, and process validation planning and execution. Your efforts will be central to translating user requirements into measurable and verifiable product requirements. Additionally, you will oversee risk management activities throughout the device lifecycle, from concept to post-launch.

Responsibilities

• Lead the creation and implementation of design control deliverables.
• Plan and execute design verification and validation activities, including process validation IQ/OQ/PQ/PPQ.
• Actively participate in core team and customer-facing meetings.
• Translate user requirements into discrete, objective, measurable, verifiable, and traceable product requirements.
• Oversee risk management activities throughout the device lifecycle.
• Create accurate and repeatable test and inspection methods.
• Support biocompatibility and sterilization qualifications.
• Analyze data and prepare product test reports.
• Maintain the completeness and integrity of the Design History File.
• Define and evaluate component specifications, including creating sampling plans and conducting First Article Inspections.
• Support supplier management activities and external audits.
• Resolve components issues and other manufacturing barriers.
• Oversee and approve document change requests, non-conformances, deviations, and special work order processes.
• Lead root cause analysis and resolution activities.
• Review and approve equipment specifications and qualification.

Essential Skills

• 5 years of experience in medical device quality engineering.
• Proficiency in design control and quality assurance.
• Experience with validation and verification processes.
• Knowledge of ISO standards and root cause analysis.
• Familiarity with first article inspection and supplier management.
• Ability to manage audits and document change orders.

Additional Skills & Qualifications

• Experience working in Contract Manufacturing Organizations (CMO) is preferred.
• Familiarity with catheter and delivery systems.
• Ability to wear multiple hats and thrive in a fast-paced environment.
• Previous experience being part of a core team in development is an advantage.

This is a Permanent position based out of Minneapolis, MN.

The pay range for this position is $48.00 - $60.00/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)

This is a fully onsite position in Minneapolis,MN.

This position is anticipated to close on Dec 22, 2025.

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 due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.

Salary : $48 - $60