Careers

Principal Development Engineer

Location: Sarasota, FL

Summary of Primary Responsibilities:

Under the supervision of the Director of R&D, is responsible for developing, commercializing, and cultivating products to support Anika’s commercial growth.  The Principal Engineer leads the design activities associated with new and existing 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 and foundational sports medicine/orthopedic devices and instruments from concept to clinic
  • Manage and mentor internal development engineers and external development consultants
  • Interact with surgeons and develop necessary training on devices and instruments
  • Manage and execute necessary verification & validation activities
  • Rely on experience and judgment to plan and accomplish goals
  • Help design and perform mechanical testing
  • Reviews, generates, and executes experimental protocols and reports to support product/process development
  • Create, update, and maintain Design History File for relevant products

Job Complexity:

Leads complex product development activities and solves complicated engineering problems where in-depth analysis of situations or data is required. Contributes significantly to the design, development, and improvement of new and existing 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)
  • 10+ 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
  • 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)

 

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We are an equal opportunity employer, and we do not tolerate discrimination based on characteristics such as age, gender, gender identity and expression, genetic status, sexual orientation, race, ethnicity, national origin, religion, disability, military status, family status, or any other protected category under federal, state, or local law.