Job Description
The Principal Design Assurance Engineer is responsible for supporting the development of new products as well as overseeing commercial products. This role involves collaboration with internal personnel, third-party contractors, and potentially external contract manufacturers.
ResponsibilitiesParticipate in New Product Development Phase Reviews and lead or participate in Design Reviews.Partner with R&D to define and determine design inputs, outputs, and their relationships.Ensure the application and satisfaction of relevant design standards.Create and support the validation of new test methods.Determine and document risks through Hazard Analysis, DFMEA, PFMEA, and UFMEA.Support the execution of design verification and validation, including usability.Generate and manage test protocols, execute tests, investigate issues, analyze data, and create reports for design verification and validation testing, including shelf life and stability.Drive improvement in Design Assurance specific quality system deliverables and processes.Support regulatory approvals and respond to regulatory questions.Manage the stability testing and execute design and process changes to commercialized products.Support the transfer of new products from development to production.Support internal and external audits.Manage statistical support for test method validations and sample size requirements.Interact with external contract manufacturers and suppliers.Provide technical support for product development in compliance with design controls, international standards, and regulatory guidelines.Manage product stability programs to ensure adequate heat-age and real-time aging for shelf life support.Conform with the Code of Conduct and all local Compliance Standards.Comply with Q/EHS Policy.Other duties as assigned.Essential SkillsExperience in the medical device industry.Expertise in design control and risk management.Bachelor's degree in Engineering or equivalent, with preference for Biomedical or Mechanical.Minimum of 7 years of related experience and/or training.Additional Skills & QualificationsASQ Certified Quality Engineer preferred.Pay and Benefits
The pay range for this position is $50.00 - $90.00/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 Aug 14, 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.