Senior Medical Device Product Development Engineer

PMT Corporation; Chanhassen (MN); On-site; USD 90,000 - 120,000; Full time

Job summary

PMT Corporation, located in Chanhassen, Minnesota, seeks a Product Development Engineer II to lead the design, development, and continuous improvement of medical devices and manufacturing processes across neurological, orthopedic, and plastic surgery areas.

You will own medium- to large-scale projects from concept through commercialization, mentor junior engineers, and ensure compliance with GMP, ISO 13485, and FDA QSR. Up to 10% travel may be required.

Qualifications

• Bachelor's degree in Biomedical Engineering, Mechanical Engineering, Chemical Engineering, or related field.
• 3–5 years of medical device engineering experience with ownership of product development cycles.
• Proficient in SolidWorks and AutoCAD; strong working knowledge of MS Office and MS Project.
• Demonstrated experience with project management, risk analysis (FMEA), and validation/verification methodologies.
• In-depth understanding of medical device regulations (FDA GMP, ISO 13485) and design control processes.
• Excellent communication, technical writing, and presentation skills.
• Self-motivated and capable of working independently and within cross-functional teams.
• Experience supporting customer and supplier communications in a technical capacity.

Responsibilities

• Lead and manage complex product development projects from concept through verification, validation, and production launch.
• Design, develop, and optimize medical devices, accessories, and manufacturing processes that align with market needs and regulatory standards.
• Develop design concepts and engineering drawings in 3D CAD (SolidWorks, AutoCAD); build prototypes and iterate designs.
• Utilize engineering software to 3D print prototypes.
• Document all design activities in accordance with SOPs and regulatory requirements.
• Lead/design verification and validation protocols; analyze results and report findings.
• Plan sample sizes and perform statistical analysis of test data.
• Manage qualification/validation testing by third-party labs; coordinate equipment qualifications.
• Generate and manage design history files and related technical documentation.
• Lead or participate in risk management activities, including FMEA and risk assessments.
• Collaborate with Manufacturing to scale production methods and improve quality/cost.
• Support Regulatory Affairs with FDA submissions and other filings.
• Mentor junior engineers and technicians; train PMT personnel on manufacturing and inspection processes.

Skills

SolidWorks

AutoCAD

MS Office

MS Project

Qualio

Education

Bachelor's degree in Biomedical/Mechanical/Chemical Engineering or related field

Tools

SolidWorks

AutoCAD

MS Office

MS Project

Qualio

Job description

PMT Corporation, located in Chanhassen, Minnesota, seeks a Product Development Engineer II to lead the design, development, and continuous improvement of medical devices and manufacturing processes across neurological, orthopedic, and plastic surgery areas.

You will own medium- to large-scale projects from concept through commercialization, mentor junior engineers, and ensure compliance with GMP, ISO 13485, and FDA QSR. Up to 10% travel may be required.