Principal Design Engineer

Summary of Primary Responsibilities:

Under the supervision of the Vice President, R&D, is responsible for developing and commercializing new products to support Anika’s commercial growth.  The Principal Engineer leads the design activities associated with new product and technology development projects. The ideal candidate will be a hands-on technical leader, considered a device subject matter expert (SME), and will provide project and engineering leadership in device and/or system identification, feasibility, development, qualification and launch readiness for sports medicine/orthopedic devices and instruments.

Specific Responsibilities:

  • Manage and execute the design process for innovative sports medicine/orthopedic devices and instruments from concept to clinic
  • Manage and mentor internal design engineers and external design consultants
  • Source vendors and oversee manufacturing for surgical instruments
  • Manage and execute verification & validation of new products (device/instruments)
  • Interact with surgeons and develop training on new devices and instruments
  • Communicate and interact with clinical advisory board and industry experts
  • Rely on experience and judgment to plan and accomplish goals
  • Help design and perform mechanical testing for proof of concept
  • Write testing protocols and reports
  • A wide degree of creativity and latitude is expected; will need to be resourceful to generate questions and come up with answers

Job Complexity:

Leads complex new product development activities and solves complicated engineering problems where in-depth analysis of situations or data is required. Contributes significantly to the concept, design and development of new products. Exercises judgment within broadly defined practices to select methods, techniques and evaluation criteria for obtaining desired results. Determines methods and procedures on new assignments.

Supervisory Responsibilities:

  • Provides coaching/mentoring to all technical levels
  • May direct the activities of technical and other cross functional resources

Experience, Knowledge, and Skills Required:

  • Bachelor of Science in Engineering/Mechanical Engineering required (MS preferred)
  • 12+ years of experience in medical device development (Orthopedics/Sports Medicine preferred)
  • A strong knowledge of developing and commercializing FDA regulated devices; a track record of gaining regulatory approval
  • Strong knowledge of project management techniques (project plans/priorities, tools and metrics
  • Proven track record of development and testing of surgical instruments and tools
  • Experience with Regulatory submissions (FDA and CE) and audit support
  • Creating DHFs and working within design controls (ISO 13485)
  • Fluent in OR environment – has attended a large number of surgeries and surgical labs
  • Experience managing surgeon and other health care professional (HCP) relationships
  • Design (CAD), analysis and prototyping skills (SolidWorks preferred)
  • Strong technical writing skills
  • Clear communicator capable of tailoring information for different audiences
  • Able to define problems, establish facts, and utilize critical and logical reasoning to draw valid, viable conclusions
  • Hands on with a bias for action, positive, energetic, self-motivated (very important)

Desired Experience, Knowledge, and Skills:

  • Finite element analysis (FEA) experience preferred


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