Process Development Engineer

We are seeking a Process Development Engineer to support the development, validation, and transfer of manufacturing processes for valve-based medical devices and associated delivery systems. This role focuses on early-stage manufacturing readiness, supporting product development activities prior to FDA submission, and ensuring robust, repeatable, and compliant manufacturing processes.

• Develop, characterize, and optimize manufacturing processes for valves, delivery systems, and related assemblies.
• Support new product introduction (NPI), design transfer, and early manufacturing builds.
• Define process flows, assembly methods, tooling concepts, and work instructions.
• Plan, author, and execute IQ/OQ/PQ process validations and Test Method Validations (TMV).
• Perform Design of Experiments (DOE), process characterization, and capability studies.
• Generate validation protocols and reports compliant with FDA and ISO standards.
• Collaborate with Quality, Regulatory, Manufacturing, and Supply Chain teams.
• Support engineering builds, pilot runs, and supplier engagement.

• 4 to 12 years of experience in medical device process development or validation.
• Medical device work history.
• Strong experience with IQ/OQ/PQ and TMV.
• Hands-on experience with medical device assemblies, preferably valves or delivery systems.
• Experience in FDA-regulated environments (21 CFR 820, ISO standards).
• Experience with catheter-based or minimally invasive delivery systems.
• Pre-FDA or early commercialization experience.
• Experience working with contract manufacturers.

• Bachelor’s degree in Mechanical, Biomedical, Manufacturing Engineering, or related field.
• Familiarity with Minitab or JMP software.

This role operates within standard working hours and embraces a casual dress attire. Our clinical-stage medical device company is committed to developing transcatheter valve solutions for the treatment of debilitating and life-threatening Tricuspid Regurgitation (TR). We utilize proprietary minimally invasive side-delivery technology to enhance patient treatment options, supported by multiple clinical studies in the United States, Europe, and Australia.

This is a Contract position based out of Maple Grove, MN.

The pay range for this position is $53.00 - $65.00/hr.

Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.

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 Maple Grove,MN.

This position is anticipated to close on Sep 1, 2026.

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 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service.

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.

San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records.

Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.

Salary : $53 - $65