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Intellectt Inc
Process Development Engineer Medical Device
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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.
Pay:
$35.00 - $38.00 per hour Expected hours: 40.0 per week
Work Location:
In person