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Project Engineer
- Posted: 05/05/2025
- Salary: Competitive
- Location: Somersworth, New Hampshire, United States
- Job Type: Permanent/Fixed Term
The Project Engineer will lead and manage medical device manufacturing and development projects at the New Hampshire facility. This role ensures projects are completed on time, within scope, and in compliance with FDA and ISO 13485 standards, contributing to company growth through strong cross-functional collaboration and project execution.
Responsibilities:
Responsibilities:
- Lead new product development and manufacturing transfer projects from concept to production.
- Perform hands-on product and tooling design using CAD and prototyping tools.
- Coordinate cross-functional teams and serve as the main point of contact for internal and external stakeholders.
- Manage project documentation, schedules, budgets, and risk assessments.
- Support production startup, validation activities (IQ/OQ/PQ, TMV), and regulatory compliance (FDA QSR, ISO 13485).
- Drive continuous improvement and mentor junior engineers.
- Collaborate with suppliers and identify cost-saving and process improvement opportunities.
- Ensure safety, quality, and accurate documentation throughout all phases.
- Bachelor’s degree in Mechanical, Biomedical, Systems Engineering, or related field.
- 5+ years of experience in regulated medical device manufacturing or product development.
- Strong project/program management experience with increasing responsibility.
- Proficient in Microsoft Office, project management tools, and SolidWorks.
- Skilled in documentation, organization, and communication.
- Knowledge of FDA regulations, ISO 13485, GMP, and medical device manufacturing processes.
- Familiar with thermoforming, thermal/ultrasonic sealing, labeling, and sterile barrier packaging.
- Design Engineering background