Process Development Engineer

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.