Sr. Biomedical Engineer

Pmt Corporation - Chanhassen, MN

Full-time - Mid Level

Chanhassen, MN

Merchant Wholesalers, Durable Goods

About the position

PMT Corporation, located in Chanhassen, Minnesota, is seeking a Senior Biomedical Engineer to join our innovative team. This role is pivotal in leading the design, development, and testing of cutting-edge medical devices and accessories. The ideal candidate will possess a strong background in product development and will be responsible for ensuring that our products not only meet regulatory standards but also address real-world medical needs. The position requires a blend of independent work and collaboration with cross-functional teams, including Research and Development, Quality Assurance, Regulatory Affairs, and Production. As a Senior Biomedical Engineer, you will lead projects from concept through production, ensuring compliance with regulatory requirements. You will perform rigorous test procedures to verify and validate product quality and efficacy, documenting all developments meticulously in scientific notebooks. Your role will also involve creating design drawings using AutoCAD or similar drafting programs and developing prototypes to advance the design process. Additionally, you will assist in training PMT personnel, including technicians, engineers, and sales representatives, in the processes associated with the design and development of medical devices. Your responsibilities will extend to developing efficient manufacturing processes that are user-friendly and cost-effective. You will also play a key role in addressing product complaints, coordinating corrective and preventative action activities, and ensuring compliance with regulatory agencies such as GMP, ISO, and FDA. Effective communication with strategic vendors and suppliers will also be a critical aspect of your role, as you work to ensure that our products are of the highest quality and meet the needs of our customers.

Responsibilities

• Lead the design and development of medical devices from concept through production
• Collaborate with cross-functional teams such as R&D, Quality Assurance, Regulatory Affairs, and Production to ensure product compliance within regulatory requirements
• Perform test procedures to verify and validate product quality and efficacy
• Document all developments in scientific notebooks and complete Engineering Change Orders (ECOs)
• Lead and/or oversee assigned projects, collaborating with stakeholders to achieve targeted outcomes
• Complete design drawings in AutoCAD or similar drafting program and create prototypes to progress development through its design stages
• Assist in training PMT personnel such as Technicians, Engineers, Sales Representatives, and Customers in processes associated with design and development of medical devices and accessories
• Develop efficient, user-friendly manufacturing processes
• Assist in the resolution, documentation, and customer responses of product complaints
• Coordinate and assist in corrective and preventative action activities and solutions
• Comply with appropriate regulatory agencies (i.e. GMP, ISO, FDA) and associated quality systems
• Communicate with strategic vendors and suppliers

Requirements

• 4 year degree in applicable field of study, Master's degree preferred
• 5-10 years' work experience in the medical device industry
• Strong product development skills, specifically ability to work with Production throughout design, development, and testing of devices and accessories
• Excellent written and verbal communication skills
• Self-starter and self-organizer
• Successful with project management
• Exceptional problem solving and design skills
• Strong personal computer skills, including experience with MS Office, Solidworks, AutoCAD, MS Project
• Able to pass background and drug screenings