Process Engineer — Medical Device (Onsite — Maple Grove, MN) Contract

Pharmavise Corporation; Maple Grove (MN); On-site; USD 90,000 - 120,000; Full time

Job summary

Pharmavise Corporation in Maple Grove, MN seeks a Process Engineer to lead the clinical build line and own process development deliverables. The role focuses on process validation documentation and supporting commercialization activities.

You will collaborate with R&D, QA, Production, Regulatory, and Equipment Engineering on complex projects, designing tests, analyzing results, and communicating findings to the technical community.

Qualifications

• Leads process development and validation activities.
• Experience with Six Sigma methodologies and robust data analysis.
• Ability to work across R&D, QA, Production, Regulatory, and Engineering teams.

Responsibilities

• Leads clinical build line and owns process development deliverables.
• Manages process validation documentation from development through commercialization.
• Supports technology development, test of materials, and specification preparation.
• Selects process improvement techniques and recommends equipment changes.
• Summarizes and analyzes complex test results and communicates conclusions.

Skills

Process development

Six Sigma

Cross-functional collaboration

Tools

Keyance

Sensofar

Job description

Process Engineer — Medical Device (Onsite — Maple Grove, MN) Contract

Maple Grove, United States | Posted on 12/09/2025

From development to commercialization, we partner with Pharmaceutical, Medical Device and Biotechnology clients to provide solutions to complex compliance issues. We collaborate with our partners by providing technical expertise in Quality, Regulatory Compliance and Manufacturing Science and Technology. Our business mission is to ensure our clients exceed their compliance goals while improving patient health and safety. Visit us at www.pharmavise.com and follow us on LinkedIn: https://www.linkedin.com/company/pharmavisecorp

Job Description

Our F500 Medical Device client has an exciting opportunity for a Process Engineer.

Job Summary: Leads clinical build line, own process development deliverables such as process validation documentation, characterize process, support commercialization activity.

Key Responsibilities:

• 1. Works cooperatively with R&D, Process Development, Quality, Production, Regulatory, Equipment Engineering, Supply Chain, and Marketing on complex projects to ensure project success.
• 2. Consistently generates innovative and unique solutions to meet department goals.
• 3. Successfully completes complex engineering work and contributes to new product development teams and product support, typically including the following activities: technology development, test of materials or products, preparation of specifications, Six Sigma, process study, process improvements, and report preparation.
• 4. Selects process improvement techniques to solve complex problems and make sound equipment and process recommendations.
• 5. Summarizes, analyzes, and draws conclusions from complex test results.
• 6. Designs and prepares complex reports and communicates results to the technical community.
• 7. Designs and coordinates complex engineering tests and experiments.
• 8. Coordinates, manages, and documents project goals and progress and recommends appropriate revisions.
• 9. Assesses the feasibility and soundness of proposed engineering evaluation tests, products, or equipment.
• 10. Completes and manages complex Capital Equipment Request Authorizations (CERA’s).
• 11. Leads cross-functional project teams.
• 12. Leads in the identification, implementation, and management of production goals.
• 13. Trains, develops, and/or provides work direction to operators, technicians, and engineers.

Quality Systems Duties and Responsibilities:

Build Quality into all aspects of their work by maintaining compliance to all quality requirements.

Qualifications:

• 5+ years of experience

Additional Job Specific Requirements:

• Knowledge of electropolishing
• Experience with Keyance and Sensofar measurement technology

Other Details:

Pharmavise Corporation is an Equal Opportunity Employer and does not discriminate on the basis of race or ethnicity, religion, sex, national origin, age, veteran disability or genetic information or any other reason prohibited by law in employment.