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Job Title: Senior Process Development Engineer

Employment Type: Full-Time

Salary Range: $90k-$130k DOE

About the Role:

We are seeking a hands-on Senior Process Development Engineer with a strong background in injection molding to join our growing team in Brooklyn Park, MN. The ideal candidate will lead the development, optimization, and validation of molding processes for new and existing products, supporting both R&D and manufacturing. Experience in medical device manufacturing or other highly regulated industries is a strong plus.

Key Responsibilities:

+ Lead process development for new injection molding programs, from concept through production.

+ Develop and optimize molding parameters to ensure part quality, consistency, and efficiency.

+ Collaborate closely with tool design, quality, and production teams to resolve process issues and drive continuous improvement.

+ Lead DOE (Design of Experiments), process capability studies, and root cause analysis.

+ Support validation activities (IQ/OQ/PQ) and documentation per internal and regulatory standards.

+ Provide technical mentorship and training to engineers and technicians.

+ Evaluate new materials, equipment, and technologies to enhance process capability and efficiency.

+ Support scale-up activities from prototype to full production.

Qualifications:

+ Bachelor’s degree in Plastics Engineering, Mechanical Engineering, or related field (advanced degree preferred).

+ 5+ years of hands-on injection molding experience, ideally in medical device or precision molding environments.

+ Strong knowledge of mold design, tooling, and polymer materials.

+ Proficient in scientific molding principles, DOE, and validation protocols.

+ Proven ability to troubleshoot complex molding and equipment issues.

+ Excellent communication, documentation, and leadership skills.

Preferred:

+ Experience working under ISO 13485 and FDA regulatory environments.

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