Process Development Contractor

Process Development Contractor in Minnetonka, MN

Experience

Required:

3–5 years

Industry

Experience:

Medical Device (Required)

• Author and execute process validation activities including TMV, IMV, IQ, OQ, PQ, and PPQ.
• Lead process development efforts, including equipment specification, acquisition, and implementation.
• Design and execute experiments (DOE); analyze data to support validation and continuous improvement.
• Evaluate current manufacturing equipment and recommend improvements for process suitability and efficiency.
• Develop and revise manufacturing documentation including SOPs, specifications, validation protocols, risk assessments, and safety procedures.
• Support tooling development, process optimization, and technical troubleshooting.
• Present validation and performance data to cross‑functional teams.
• Recommend new methods, materials, and technologies to improve quality and operational efficiency.
• Provide technical training and process expertise to engineering and manufacturing teams.
• Collaborate cross‑functionally to ensure compliance, safety, and continuous improvement initiatives.

• 3–5 years of process development experience in medical device manufacturing.
• Strong understanding of engineering principles and problem‑solving methodologies.
• Experience with validation documentation and regulated environments.
• Knowledge of quality systems and compliance standards.
• Excellent analytical, documentation, and communication skills.