Design Assurance Engineer

Job Description

As a Design Assurance Engineer, you will guide the Design Control process for product development projects, setting strategies and driving towards compliant and efficient solutions to complex problems. You will be responsible for Design Verification and Validation planning and execution, leading root-cause investigations and resolution activities.

Responsibilities

• Guide the Design Control process for product development projects.
• Set strategies and drive towards compliant and efficient solutions to complex problems.
• Responsible for Design Verification and Validation planning and execution.
• Lead root-cause investigations and resolution activities.
• Review, provide feedback, and approve project design and development deliverables as the quality lead.
• Lead Risk Management and Usability program activities from product concept through commercialization.
• Perform risk and impact assessments for design changes to products.
• Ensure DHF content integrity, completeness, and regulatory/standards compliance; collaboratively communicate and resolve gaps.
• Support design test and inspection method development, and lead method validation activities.
• Write risk management plans, design verification and validation plans, and author associated reports.
• Co-own, with the project manager, the processes and documentation for design reviews, DHF content structure, and project Design Reviews.
• Review and approve development build records.

Essential Skills

• 5+ years' experience in medical device design assurance.
• Proficiency in design verification and quality assurance/testing.
• Knowledge of validation, new product development, project management, quality engineering, design control, and risk management.
• Experience with ISO standards, non-conforming processes, CAPA, root cause analysis, supplier quality, and quality management systems.

Additional Skills & Qualifications

• Bachelor's Degree (BS) in life science discipline or equivalent combination of education and experience.
• 2+ years of experience in medical device development, with experience primarily in quality assurance/design verification.
• Experience working in quality systems as defined in 21 CFR 820 and ISO standards.
• Experience working on sterile, single-use products such as catheters and implantable leads.
• Familiarity with ISO -1, ISO , ISO -1, ISO standards.

Pay and Benefits

The pay range for this position is $55.00 - $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)

Workplace Type

This is a fully onsite position in Maple Grove,MN.

Application Deadline

This position is anticipated to close on Jun 27, 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.