Design Engineer II

ConforMIS in Billerica, MA

  • Type: Full Time
position filled
Job Summary: The Design Engineer II will be responsible for the design of orthopedic joint implants and instrumentation systems and the creation of documentation in the support of quality systems. Essential Duties and Responsibilities: Develop and maintain strong internal working relationships across Conformis. Understand the objectives, responsibilities, and mission of the Engineering department and work towards those goals. Prioritize and plan work activities; adapt for changing conditions. Using CAD software, create product designs to product and marketing specification. Communicate with customers, sales, marketing, and independent entities to gain knowledge of product design requirements. Develop protocols for design verification and validation (V&V), including outside test and research labs. Complete corresponding test reports. Conduct risk analysis, such as FMEAs; to determine required testing for design V&V. Oversee prototype fabrication internally and at suppliers. Develop design documentation for the manufacture of product including drawings, BOMs, product specifications and product validations. Develop innovative CAD techniques to streamline design and production processes. Work with project plans to execute assigned projects. Other responsibilities as assigned. Qualifications: BS in Mechanical Engineering or equivalent degree. 2-5 years of product development experience (or 1-4 years with MS degree). 2+ year experience in the design of medical devices, orthopedic experience preferred. Intermediate to advanced 3D CAD skills ProEngineer or Solidworks (Modeling & Drawings). Rapid prototyping knowledge preferred. Orthopedic and other biocompatible materials. GMP, Packaging, and sterilization systems. Good understanding of Design Control and QSR. Experience drafting biomechanical test protocols and test reports. Skills, Abilities, Competencies Required: Excellent written and verbal communication skills. Able to work accurately in a fast-paced, hectic, ever-changing environment with strong attention to detail. ·      Demonstrated ability to monitor own work to ensure quality, accuracy and thoroughness. Strong organizational, analytical and time-management skills. Able to self-motivate and work both independently and as part of a team. Demonstrated ability to create concepts from brief customer requirements. Excellent research, problem-solving and learning skills. Able to work in changing environments (reduced lighting, increased noise, temperature variances, unpleasant odors, etc.). Busy work environment with frequent interruptions. Must be aware of hazards within the company; adhere to quality and safety standards established by FDA and other regulatory agencies. Conformis is an Equal Opportunity Employer

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