Process Development Engineer

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

Job Description

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, 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.
• Partner with Quality, Regulatory, Manufacturing, and Supply Chain teams.
• Support engineering builds, pilot runs, and supplier engagement.

• 2 to 12 years of experience in medical device process development or validation.
• Hands‑on experience with medical device assemblies, particularly valves or delivery systems.
• Strong expertise in IQ/OQ/PQ and TMV.
• 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.

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

• 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 May 27, 2026.

Actalent 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.