We are hiring a Research & Development (R&D) Engineer to lead and drive medical product developments from concept to commercialization. Projects include new product development and introduction, and maintenance of existing product lines. This role is part of our growing Medical business, which is one of our high value segments.

This role provides an opportunity to work on our most recently launched product line of Medical Adhesives.

Primary Responsibilities and Essential Job Functions:

  • Translate product requirements into product specifications by selecting and testing appropriate materials, product designs, and manufacturing processes.

  • Prepare technical documents fulfilling regulatory requirements for medical devices (e.g. 510k, CE mark).

  • Understand and stay in sync with cGMP, ISO 13485, and FDA 21 CFR Part 820 regulations.

  • Assist in the investigation of customer complaints and nonconformance as the need arises.

  • Prepare project plans and decide timeline and resources for project.

  • Support product maintenance, including raw material substitutions and line extensions.

  • Follow a stage-gated New Product Development Process and/or Design Controls.

  • Use internal and external specialists in network to accomplish goals.

  • Conduct literature and patent searches.

  • Work closely with design engineers.

  • Work under general direction, independently identifying and developing approaches to solutions. Work is then reviewed upon completion for adequacy in meeting objectives.

  • Represent R&D within the company and with outside customer contacts.

  • Perform other tasks as assigned.

  • Ph.D. degree in biomedical, biomechanical, chemical engineering, polymer science & Engineering, or related education is required. Candidates with a Bachelor's or Master's degree in a related field with at least 3 years of product development experience within the medical device field would also be considered.

  • Consistent track record of successfully developed products.

  • Ability to interface effectively with multi-functional groups to define and execute overall requirements.

  • Independent problem solver, hands-on scientist, highly upbeat, great teammate, and proactive.

  • Able to travel domestically and internationally on as needed basis.

  • Familiarity with the following areas would be strongly preferred:

    • Transport phenomena

    • Thermodynamics of Solubility

    • Analytical Methods

    • Principles of Materials Science

    • Statistics

Position Id