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April 29, 2021

Job Description

Embody, Inc.

Product Development Engineer II – Sports Medicine

Located in Norfolk, VA, Embody is pioneering the next generation regenerative platform for the repair of tendon and ligament injuries with novel collagen-based bio-fabrication techniques and products for the fast-growing sports medicine market. Founded in 2014 and funded with $20 million in DARPA & DOD funding, the company is developing unique biomaterials with an initial focus on orthopedic applications including foot & ankle, shoulder, and knee tendon and ligament repair.

Job Description:

The role of Product Development Engineer II will be responsible for the product design, maintenance, and Medical Device Registration of surgical implants, instrumentation for sports medicine applications including arthroscopic soft tissue and shoulder repair. This role will include all technical development aspects of the project, while working closely with other members of the project cross-functional partners, and surgeons to define design inputs through verification & validation plans and testing and will support regulatory processes for global registration efforts. The Product Development Engineer II will lead all functional design, prototyping, tolerance studies and perform design evaluations (FEA, simulated use testing, dry labs and wet tissue labs etc.), and will support generating documentation of clinical and surgical technique observations to create meaningful solutions to surgical challenges.

Key Responsibilities:

  • Provide leadership, direction and execution of engineering projects and tasks related to programs
  • Design and develop medical device components and assemblies as well as associated test and fabrication fixtures
  • Establish product requirements, design inputs and specifications
  • Identify and mitigate design and product risks
  • Plan and execute verification and validation activities
  • Work with product marketing, physicians and other medical personnel to obtain feedback on concepts
  • Use empirical, numerical and experimental methods to analyze physical systems and designs
  • Perform tolerance analyses of complex assemblies
  • Define test methods and conduct testing
  • Explore and understand the root cause of technical problems and proposing solutions
  • Make critical judgements and decisions, documenting these decisions with supporting evidence cross-functionally with internal groups and external vendors to obtain prototype parts and to understand their capabilities and limitations
  • Conduct pre-clinical and clinical testing of devices
  • Conduct detailed design reviews at various design stages
  • Work with manufacturing engineering and/or suppliers to optimize designs for manufacturability and assembly
  • Expand the intellectual property portfolio through with novel ideas and concepts
  • Demonstrate strong verbal and written communication skills with the ability to effectively communicate at multiple levels within the organization
  • Have a detailed understanding of the clinical environment (i.e. current treatment methods, surgical techniques, and emerging clinical needs, etc.)
  • Perform other related duties or responsibilities
  • Support all company initiatives as identified by management and in support of quality management systems (QMS) or other regulatory requirements
  • Others not defined herein, on occasion or as assigned

Experience and Skills:

  • BS in Mechanical Engineering (or similar discipline) 5-7 years of relative experience
  • Proven ability to lead projects from inception to commercialization
  • Experience translating customer needs into product requirements/design inputs
  • Knowledge and practical application of medical device product development regulations (ISO, GMP, FDA, CE) and design controls
  • Experience with sports medicine products and techniques including suture development.
  • Travel Requirements: 10-20%
  • Ability to occasionally lift 35lbs

Job Type: Full-time

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