Pre ID candidate
IntePros
Bergen County, NJFresher1h agovia LinkedIn
Associate Process Engineer (Medical Devices)
Location: Bergen County, NJ
Type: 12-month contract (starts early-to-mid November 2026)
About the Role
IntePros is hiring an Associate Process Engineer for a leading medical device manufacturer. This is an opportunity for an early-career mechanical engineer to gain hands-on experience in validation and process engineering in a regulated industry. You will work alongside experienced engineers to develop and improve manufacturing processes, qualify new equipment and production lines, and create documentation to support new technologies and processes.
Key Responsibilities
- Validation protocols: Write, execute, and close out Installation, Operational, and Performance Qualification (IQ/OQ/PQ) protocols for production lines and equipment.
- Data analysis and reporting: Collect and analyze process and experimental data using statistical methods, and write validation reports.
- Change control: Evaluate Engineering Change Orders (ECOs) and process changes to determine the need for re-validation.
- Documentation: Draft and update SOPs, work instructions, preventive maintenance procedures, and equipment manuals.
- Process development: Develop and refine process methods and controls to meet quality standards, and recommend improvements.
- Collaboration: Review product development requirements with the team to ensure alignment with manufacturing processes, costs, and timelines.
Requirements & Tech Stack
- Bachelor’s degree in Mechanical Engineering
- Strong technical writing skills, especially SOPs and validation documents
- Ability to work well under pressure and meet deadlines
- A collaborative approach to working with other engineers
Qualifications
- Hands-on and mechanically inclined
- Validation experience, including internships or co-ops
- Experience with OnePLM/Windchill
- Exposure to design reviews