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August 21, 2021

Embody, Inc.

Senior Product Development Engineer

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 and delivery systems with an initial focus on orthopedic applications including foot & ankle, shoulder, and knee tendon and ligament repair.

Job Description:

The Product Development Engineer II will be responsible for the design and development of surgical implants and instrumentation for sports medicine applications including arthroscopic tendon and ligament repair. This role will include all technical aspects of new product development projects, from defining design inputs to creating and executing test methods for design verification and validation, while working closely with cross-functional project teams.  The Product Development Engineer II will also provide technical support for manufacturing process development, regulatory submissions and commercial operations.

Key Responsibilities: 

  • Provide leadership, direction and execution of design and engineering tasks related to medical device new product development initiatives
  • Establish product requirements, design inputs and specifications based on user needs
  • Work with sales & marketing, physicians and other medical personnel to obtain user needs and feedback on products in development
  • Identify and mitigate design and product risks, generate risk management documentation
  • Plan and execute verification and validation activities, including developing and validating test methods
  • Use empirical, numerical and experimental methods to analyze physical systems and designs
  • Perform tolerance analyses of complex assemblies
  • Explore and understand the root cause of technical problems and propose solutions
  • Conduct/provide technical support for pre-clinical and clinical testing of devices
  • Work with manufacturing engineering and/or suppliers to optimize designs for manufacturability and assembly
  • Demonstrate strong written and verbal communication skills with the ability to effectively communicate at multiple levels within the organization
  • 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, Biomedical Engineering or similar discipline
  • 3-5 years of medical device industry experience required, specific experience in orthopedics and sports medicine preferred
  • 3D modeling and 2D drawing experience required
  • Knowledge and practical application of FDA Quality System Regulations, ISO 13485, and Design Controls
  • Experience translating customer needs into product requirements/design inputs
  • Experience in the development, validation and execution of test methods for design verification and validation
  • Experience applying statistical techniques and analysis
  • Proven ability to lead medical device product development projects from concept to commercialization
  • Travel Requirements: 10-20%

Apply on LinkedIn – https://www.linkedin.com/jobs/view/2689395765/