Job Title: Sr. Design Assurance Engineer

Job Description

The Senior Design Assurance Engineer is a quality engineer that directly supports medical device product development from concept through commercialization. Working with cross-functional development teams, you will establish and maintain design control deliverables, risk management activities, and DHF compliance to ensure the delivery of the highest quality product to the customer.

Responsibilities

• Create and ensure on-time execution of Quality Plans for internal development, OEM-based, Clinical Product Development (CPDP), and design change projects.
• Lead and ensure the on-time completion of protocols, reports, and assigned project deliverables.
• Accountable for Design Verification and Validation planning and execution, including active cross-functional root-cause analysis investigation and resolution activities.
• Lead Risk Management activities from product concept through commercialization.
• Support design test and inspection method development, and lead method validation activities.
• Ensure DHF content integrity, completeness, and regulatory/standards compliance; collaboratively communicate and resolve gaps.
• Support and ensure internal and external audit responses and on-time product re-certifications.
• Establish objective, measurable, discrete, and verifiable customer and product requirements.
• Define objective component specifications, develop supplied component sampling plans, and qualify vendors.
• Provide support for biocompatibility and sterilization qualifications.
• Develop and lead other team members, providing work direction to 2-3 technicians assigned for inspection, testing, and project support.
• Perform other functions as required.

Essential Skills

• BS in Industrial Engineering, Engineering, or Business Degree
• 8-15 years of experience in medical device Quality Operations or equivalent experience
• Comprehensive understanding of FDA regulations
• 1-3 years of direct or indirect supervisory experience

Additional Skills & Qualifications

• Statistical and data analysis skills
• Supervisory, solid management, and strong leadership experience

Work Environment

This role offers significant growth opportunities, with the team projected to expand by 5% in 2024. You will be working at a senior to principal level, requiring the ability to work independently with little to no direction. The role is on the development side, addressing project work that is currently overburdening the existing team of four engineers. You will be responsible for taking on tasks and projects to alleviate the workload of other engineers.

Pay and Benefits

The pay range for this position is $50.00 - $65.00/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 Fridley,MN.

Application Deadline

This position is anticipated to close on Mar 31, 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.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

• Hiring diverse talent
• Maintaining an inclusive environment through persistent self-reflection
• Building a culture of care, engagement, and recognition with clear outcomes
• Ensuring growth opportunities for our people

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

Salary : $50 - $65