Process Development Engineer – Medical Device

Location: Minnetonka, MN

Employment Type: Contract (W2/1099/C2C)

Duration (if contract): 6 months contract with possible extension

Salary: The salary range for this position is $35/hr - $40/hr

Benefits: This is a contract position and does not include employer-provided benefits.

Job Description:

We are seeking a Process Development Engineer with medical device industry experience to support process development, equipment qualification, validation, and continuous improvement activities.

Responsibilities:

• Author and execute validation protocols, including IQ, OQ, PQ, PPQ, TMV, and IMV.
• Support process development, equipment specification, installation, and implementation.
• Conduct experiments, testing, data analysis, and process optimization.
• Troubleshoot manufacturing processes and equipment and recommend improvements.
• Prepare and revise SOPs, validation protocols, reports, risk assessments, and technical documentation.
• Collaborate with engineering, manufacturing, quality, and R&D teams to ensure product quality and regulatory compliance.

Required Qualifications:

• 1–3 years of relevant engineering experience in the medical device industry.
• Bachelor's degree in Mechanical Engineering, Biomedical Engineering, Manufacturing Engineering, Industrial Engineering, or a related technical discipline preferred.
• Experience with manufacturing process development, process validation, or equipment qualification in a regulated environment.
• Familiarity with validation methodologies such as IQ, OQ, PQ, PPQ, TMV, and/or IMV.
• Experience preparing or executing validation protocols, test procedures, technical reports, or manufacturing documentation.
• Strong analytical, troubleshooting, and problem-solving skills.

Benefits: Eligible employees may have access to benefits offered by Intellectt Inc. in accordance with the applicable benefit plans and eligibility requirements.

Equal Employment Opportunity:

Intellectt Inc. is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, disability, genetic information, veteran status, or any other characteristic protected by applicable federal, state, or local law.