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 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.

Final date to receive applications

This position is anticipated to close on Jun 12, 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 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

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 actalentaccom 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.