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Job Description:

Under guidance of senior engineering staff, this position will be responsible for medical device design and development consisting of, but not limited to, instrumentation, packaging, test methodology, and related components to support a major new product development initiative and platform. This individual may also develop concepts, drawings and prototypes for new products and product platforms and may also work with vendors and customers and surgeons to further development activities.

 

Essential Duties and Responsibilities:

  • Have a basic understanding of medical device development including intended use, user needs and functional requirements;
  • Ability, with assistance, to identify and develop novel in-vitro test methods that simulate the clinical application to verify device functional requirements with a focus on material and chemical characteristics;
  • Write technical documentation to support design control requirements, including test protocols, test reports and/or detailed CAD drawings;
  • Interfaces with project leader, team and outside contractors to develop device prototypes to support clinical trials;
  • Work with engineering team to develop prototypes and test protocols that conform to the applicable standards and the intended uses;
  • Interface with surgeons, customers, vendors, contractors, investors, and other internal and external constituents;
  • Support the development of production processes;
  • Think creatively, problem solve, develop innovative solutions based on sound engineering skills; and
  • Perform other tasks as may be required from time to time.

 

Essential Education, Skills, Environment Education and Work Experience:

  • 4th or 5th year Bachelor’s candidate in Chemical, Biomedical or Materials Engineering;
  • Master’s or PhD candidate preferred;
  • Relevant experience to consist of product development & design within the medical device industry in accordance with regulated design controls;
  • Must be a driven, entrepreneurial self-starter with the capability to work independently and intimately with project team;
  • Extremely creative, resourceful and analytical;
  • Must be a risk-taker and not afraid to fail, try new things, and pursue “outside the box” ideas;
  • Must have excellent computer skills (MS Project, Word, Excel, etc.);
  • Must have persuasive oral and written communication skills;
  • Must be comfortable working on high-risk, early stage technologies in a fast paced, high pressure start-up environment driven by deadlines; and
  • Must have a persistent hands-on approach in a lab setting.

 

Specialized Knowledge and Skills:

  • Experience with analytical testing using X-ray diffraction, HPLC, SEM;
  • The ability to work in a multi-cultural, multi-discipline teams in developing medical products;
  • The ability to assist in the development and perform product testing to include physical, chemical and mechanical testing;
  • The internal motivation to drive towards project goals;
  • The ability to build positive relationships inside and outside the Company; and
  • The willingness to do “whatever it takes” to help a start-up business “get off the ground” and assist in all necessary areas to achieve success.