Process Development Engineer

Process Development Engineer 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.

Responsibilities:

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.

Essential Skills:

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.

Additional Skills & Qualifications:

Bachelor's degree in Mechanical, Biomedical, Manufacturing Engineering, or related field. Familiarity with Minitab or JMP. Job Type & Location This is a Contract to Hire position based out of Maple Grove, MN. Pay and Benefits The pay range for this position is $53.00 - $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 Maple Grove,MN.

Application Deadline This position is anticipated to close on Apr 14, 2026. Diversity, Equity & Inclusion At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I is 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 Actalent is an equal opportunity employer. About Actalent Actalent is a global leader in engineering and sciences services. For more than 40 years, we've helped visionary companies advance their goals. Headquartered in the United States, our teams span 150 offices across North America, EMEA, and APAC—with four delivery centers in India led by 1,000+ extraordinary employees who connect their passion with purpose every day. Our Bangalore, Hyderabad, Pune, and Chennai delivery centers are hubs of engineering expertise, with core capabilities in mechanical and electrical engineering, systems and software, and manufacturing engineering. Our teams deliver work across multiple industries including transportation, consumer and industrial products, and life sciences. We serve more than 4,500 clients, including many Fortune 500 brands. Learn more about how we can work together at actalentservices.com.