Senior Medical Device Project Engineer

Michael Page; Somersworth (NH); On-site; USD 120,000 - 140,000; Full time

Benefits offered by this job

Competitive salary ranging from $120,000 to $140,000 per year

Comprehensive benefits package available

Job summary

A medical device manufacturing company in Somersworth, New Hampshire, is looking for a Project Engineer to lead and execute medical device manufacturing and product development projects. This role emphasizes timely project delivery within budget and compliance with FDA Quality System Regulations. Candidates should possess at least a Bachelor's degree in engineering and have a solid background in regulated medical device environments, ideally with 7+ years of experience in the field.

Qualifications

• At least 7 years of experience in regulated medical device manufacturing or product development.
• Knowledge of FDA regulations, ISO 13485, GMP, and common medical device manufacturing processes.
• Hands‑on approach with a strong sense of ownership and craftsmanship.

Responsibilities

• Manage all phases of new product development and manufacturing transfer projects.
• Perform hands‑on design work for products and tooling using CAD.
• Act as the main point of contact between internal teams and customers.

Skills

Project management

Design work using CAD (SolidWorks)

Excellent documentation skills

Strong communication skills

Education

Bachelor's degree in Mechanical, Biomedical, Systems Engineering, or related field

Tools

SolidWorks

Microsoft Office

Project management tools

Job description

A medical device manufacturing company in Somersworth, New Hampshire, is looking for a Project Engineer to lead and execute medical device manufacturing and product development projects. This role emphasizes timely project delivery within budget and compliance with FDA Quality System Regulations. Candidates should possess at least a Bachelor's degree in engineering and have a solid background in regulated medical device environments, ideally with 7+ years of experience in the field.