Michael Page
Medical Device Manufacturing - Project Engineer - Dover, NH
Michael Page, Dover, New Hampshire, us, 03821
Medical Device Manufacturing - Project Engineer - Dover, NH
1 day ago Be among the first 25 applicants
This range is provided by Michael Page. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.
Base pay range $100,000.00/yr - $135,000.00/yr
Lead full‑cycle new product development (NPD) and manufacturing transfer projects from concept through production, ensuring compliance with FDA QSR and ISO 13485 standards. Perform hands‑on design and prototyping using SolidWorks, 3D printing, and precision tooling while coordinating cross‑functional teams to deliver innovative medical device solutions.
Our client is a rapidly growing medical device manufacturer committed to delivering innovative, high‑quality solutions that improve patient outcomes. They pride themselves on precision, collaboration, and an entrepreneurial culture where engineers play a direct role in shaping the company's success.
Description
Lead and manage full‑cycle medical device NPD and manufacturing transfer projects.
Perform hands‑on design and development using SolidWorks, CAD, and manual or automated machining tools.
Coordinate cross‑functional activities between R&D, Quality, Regulatory, Manufacturing, and Supply Chain teams.
Develop and maintain detailed project documentation including schedules, budgets, and risk assessments.
Oversee the launch of new production lines and provide operator training and support.
Support validation efforts (IQ/OQ/PQ/PPQ/TMV) and ensure regulatory compliance with FDA QSR and ISO 13485.
Mentor junior engineers and contribute to process improvement initiatives across the organization.
Profile
Bachelor's degree in Mechanical, Biomedical, or Systems Engineering (or related discipline).
7+ years of experience in regulated medical device manufacturing or product development.
Proficient in SolidWorks and project management tools (PMP certification preferred).
Strong working knowledge of FDA, ISO 13485, GMP, and validation practices.
Hands‑on approach with experience in thermoforming, sealing, labeling, and packaging processes.
Demonstrates ownership, problem‑solving, and leadership in fast‑paced, small‑team environments.
Job Offer
Opportunity to lead complex, high‑impact medical device projects from concept to commercialization.
Collaborative, innovative work culture with direct access to leadership.
Competitive compensation and benefits package.
Professional growth within a company dedicated to technical excellence and continuous improvement.
MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.
Seniority level
Entry level
Employment type
Full-time
Job function
Medical Equipment Manufacturing and Packaging and Containers Manufacturing
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This range is provided by Michael Page. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.
Base pay range $100,000.00/yr - $135,000.00/yr
Lead full‑cycle new product development (NPD) and manufacturing transfer projects from concept through production, ensuring compliance with FDA QSR and ISO 13485 standards. Perform hands‑on design and prototyping using SolidWorks, 3D printing, and precision tooling while coordinating cross‑functional teams to deliver innovative medical device solutions.
Our client is a rapidly growing medical device manufacturer committed to delivering innovative, high‑quality solutions that improve patient outcomes. They pride themselves on precision, collaboration, and an entrepreneurial culture where engineers play a direct role in shaping the company's success.
Description
Lead and manage full‑cycle medical device NPD and manufacturing transfer projects.
Perform hands‑on design and development using SolidWorks, CAD, and manual or automated machining tools.
Coordinate cross‑functional activities between R&D, Quality, Regulatory, Manufacturing, and Supply Chain teams.
Develop and maintain detailed project documentation including schedules, budgets, and risk assessments.
Oversee the launch of new production lines and provide operator training and support.
Support validation efforts (IQ/OQ/PQ/PPQ/TMV) and ensure regulatory compliance with FDA QSR and ISO 13485.
Mentor junior engineers and contribute to process improvement initiatives across the organization.
Profile
Bachelor's degree in Mechanical, Biomedical, or Systems Engineering (or related discipline).
7+ years of experience in regulated medical device manufacturing or product development.
Proficient in SolidWorks and project management tools (PMP certification preferred).
Strong working knowledge of FDA, ISO 13485, GMP, and validation practices.
Hands‑on approach with experience in thermoforming, sealing, labeling, and packaging processes.
Demonstrates ownership, problem‑solving, and leadership in fast‑paced, small‑team environments.
Job Offer
Opportunity to lead complex, high‑impact medical device projects from concept to commercialization.
Collaborative, innovative work culture with direct access to leadership.
Competitive compensation and benefits package.
Professional growth within a company dedicated to technical excellence and continuous improvement.
MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.
Seniority level
Entry level
Employment type
Full-time
Job function
Medical Equipment Manufacturing and Packaging and Containers Manufacturing
#J-18808-Ljbffr