Medical Device Product Development Engineer – Impactful

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

Job summary

PMT Corporation in Chanhassen, Minnesota seeks a Product Development Engineer to design and develop medical devices and accessories across neurology, orthopedics, and plastics. You will train technicians and engineers, perform IQ/OQ/PQ, and support the Quality System.

The role requires a 4-year engineering degree, 2+ years of industry experience, strong communication and problem solving skills, and proficiency with SolidWorks and MS Office.

Qualifications

• 4 yr degree in applicable field of study, preferably engineering (ME, ChE, EE, BioMed)
• Minimum 2 years work experience in industry
• Good written and verbal communication skills
• Project management, self-starter and self-organizer. Excellent problem solving and design skills.
• Strong personal computer skills, including experience with SolidWorks, and Microsoft software; Word, Outlook, Excel and etc.

Responsibilities

• Design and develop medical devices and accessories.
• Complete design drawings in SolidWorks and create feasibility prototypes.
• Use established procedures to improve existing medical devices and accessories.
• Perform statistical analysis of test data and required sample sizes.
• Execute test procedures to verify and validate current product quality and efficacy.
• Perform equipment qualifications (IQ, OQ, PQ), ensure tools are calibrated and complete process validation testing.
• Accomplish new or updated product design verification and validation testing.
• Document all testing results in scientific notebooks and design history files.
• Complete Change Controls (CC) to document procedures and designs.
• Ensure new product development is document through the required design stages.
• Complete design input and design output verifications.
• Continually optimize manufacturing procedures to produce less expensive, higher quality medical devices.
• Design new and / or repair existing tooling and equipment.
• Assist in training PMT personnel with manufacturing and / or inspection processes.
• Develop efficient (i.e. cost, material, time, etc.), user-friendly manufacturing processes.
• Support Regulatory Affairs with FDA 510K submissions and audits of the Quality System.
• Assist with maintenance of required documentation and the Quality System.
• Investigate root causes of product complaints and assist in resolution, documentation, customer responses and corrective actions, (as needed).
• Investigate root cause of non-conformity reports (NCR), product rejects and assist in resolution, documentation, and corrective actions, (as needed).
• Coordinate, manage and assist in corrective and preventative actions.
• Comply with appropriate regulatory agencies (i.e. GMP, ISO, FDA, MDR, etc.) and associated quality systems described in PMT's documentation.
• Support PMT customers and Sales representatives from a technical standpoint and attend trade shows, as needed.
• Design customer requested non-standard or custom devices.
• Communicate with surgeons and suppliers.
• Design team leader or team member.
• Risk Management team leader or team member.

Skills

Communication

Project management

Problem solving

Education

Bachelor's degree in engineering

Tools

SolidWorks

Microsoft Office

Job description

PMT Corporation in Chanhassen, Minnesota seeks a Product Development Engineer to design and develop medical devices and accessories across neurology, orthopedics, and plastics. You will train technicians and engineers, perform IQ/OQ/PQ, and support the Quality System.

The role requires a 4-year engineering degree, 2+ years of industry experience, strong communication and problem solving skills, and proficiency with SolidWorks and MS Office.