Product Development Engineer II

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

Find Fulfillment in Work Every Day! We Offer Careers that Make a Difference.

PMT Corporation, located in Chanhassen, Minnesota, is known for manufacturing and distributing high end, innovative products within the Orthopedic, Neurosurgery, and Plastic Surgery markets. Our workplace is a community of innovators who are passionate about creating an impact. We recognize that the collective power of our team is what propels us forward. Together, we celebrate successes, learn from challenges, and continuously evolve in our pursuit of excellence.

Join us at PMT Corporation if you're ready to be a part of a collaborative, idea-driven, and communicative environment. Your innovation matters, and together, we can continue to shape the future of the medical device industry.

PRODUCT DEVELOPMENT ENGINEER II OVERVIEW:

This position is responsible for leading the design, development, and continuous improvement of medical devices, device accessories, and manufacturing processes for the current product lines in neurological, orthopedic, and plastic / reconstruction surgery areas. The Product Development Engineer II takes ownership of medium- to large-scale projects from concept through commercialization, ensuring products are safe, effective, high quality, and compliant with applicable regulatory standards. This position also mentors junior engineers and technicians, provides technical training across cross-functional teams, and serves as a technical resource for Sales, customers, surgeons, and suppliers. This position can have up to 10% travel time to attend tradeshows, industry events, or other relevant events.

DUTIES OF THE PRODUCT DEVELOPMENT ENGINEER II (include but not limited to):

• 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 through each phase of development.
• Utilize engineering software to 3D print prototypes.
• Ensuring and completing all documentation in accordance with internal standard operating procedure, external standards and regulations.
• Ensure new product development is documented through all required design control stages, including design input and design output verification.
• Create, review, and execute design verification and validation protocols; analyze, document, and report results.
• Determine required sample sizes and perform statistical analysis of test data.
• Manage qualification and validation testing conducted by third party testing labs
• Plan and execute equipment qualifications (IQ, OQ, PQ) and process validations; ensure tools and equipment are calibrated.
• Generate and manage technical documentation, including but not limited to Change Controls (CC) , design history files, IFU/product manuals, technical files, test validation protocols & reports, risk management files, biological evaluation plan & reports, clinical evaluation plan & reports, clinical literature review, and scientific notebooks.
• Lead or participate in risk management activities, including FMEA and risk assessments.
• Partner with Manufacturing to develop scalable, cost-effective, user-friendly production methods; continually optimize procedures to reduce cost and improve quality.
• Design new, maintain, and / or repair existing tooling and equipment.
• Assist the manufacturing supervisor with ensuring weekly product output is maintained.Drive root cause analysis, corrective and preventive actions (CAPA), and resolution of complex product complaints, non-conformance reports (NCRs), and product rejects, including documentation and customer responses.
• Support Regulatory Affairs with FDA 510(k) submissions and other regulatory filings.
• Support and participate in internal and external audits; maintain compliance with GMP, ISO 13485, FDA QSR, MDR, and PMT's Quality System.
• Mentor and support junior engineers and technicians; provide technical training to PMT personnel on manufacturing and inspection processes.
• Interface with Sales, Marketing, Regulatory, and Quality to align technical deliverables with business objectives.
• Provide technical support to customers and Sales representatives; attend trade shows, as needed.
• Design customer-requested non-standard or custom devices; communicate with surgeons and sales representatives on device requirements.
• Maintain communication with strategic vendors and suppliers to ensure quality and timely execution of development projects.
• Other duties and responsibilities as required. Duties, responsibilities and activities may change at any time with or without notice.

QUALIFICATIONS:

• Bachelor's degree in Biomedical Engineering, Mechanical Engineering, Chemical Engineering, or related technical field.
• Minimum 3-5 years of engineering experience in the medical device industry, including ownership of product development cycles.
• Proficient in SolidWorks and AutoCAD; strong working knowledge of MS Office and MS Project. Experience using Qualio software is preferred, but not required.
• 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.
• Proven problem-solving and critical thinking capabilities.
• Self-motivated and capable of working independently and within cross-functional teams.
• Experience supporting customer and supplier communications in a technical capacity.

PMT is an Equal Opportunity Employer