Associate Process Engineer — Medical Device (12-Month Contract)

Impact Business Group; Mahwah (NJ); Presencial; USD 70.000 - 90.000; Jornada completa

Descripción de la vacante

Impact Business Group is seeking an on-site Associate Process Engineer for a 12-month+ contract in Mahwah, NJ. The role is Monday–Friday, 8:00 AM–5:00 PM ET, with collaboration across manufacturing, quality, and R&D to drive process improvements.

You will develop and modify process formulations, draft IQ/OQ/PQ protocols for production lines, collect and analyze data, and support ECO evaluations to ensure quality, efficiency, and compliance in a fast-paced medical device environment.

Responsabilidades

• Developing and modifying process formulations, methods, and controls to meet quality standards.
• Recommending and implementing improvements, modifications, and additions to process documentation.
• Reviewing product development requirements for compatibility with processing methods and determining costs and schedules.
• Integrating equipment and material capabilities to meet process module and technology target specifications.
• Drafting and executing Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols for production lines and equipment.
• Collecting, compiling, and analyzing experimental and process data using statistical methods and authoring clear, concise validation reports.
• Supporting the evaluation of Engineering Change Orders (ECOs) and process modifications to determine validation impacts and execution requirements.
• Drafting and updating work instructions, preventive maintenance procedures, and equipment operating manuals based on validated parameters.

Descripción del empleo

Impact Business Group is seeking an on-site Associate Process Engineer for a 12-month+ contract in Mahwah, NJ. The role is Monday–Friday, 8:00 AM–5:00 PM ET, with collaboration across manufacturing, quality, and R&D to drive process improvements.

You will develop and modify process formulations, draft IQ/OQ/PQ protocols for production lines, collect and analyze data, and support ECO evaluations to ensure quality, efficiency, and compliance in a fast-paced medical device environment.