Manager, Design Engineering

Job Summary:

The Manager, Design Engineering will be responsible for leading design projects from initial concept stage through final shipment release, conducts brainstorming and design review meetings to develop and evaluate design, performs Risk Analysis evaluation and develop mitigation strategies, oversees testing requirements, testing and implantation of design to assist with product verification, oversees regulatory/design history documents for projects, management of entire engineering change life cycle, tracks projects progress and reports status.

Essential Duties and Responsibilities:

  • Manage, direct and support the Engineering team.  Hire, train, develop, teach, coach, mentor, motivate, discipline, and reward staff members.
  • Meet regularly with direct reports to review performance, identify any issues and set expectations of goals.
  • Investigates materials, processes and design options of highly innovative implantable medical device systems.
  • Develop and implement project plans.
  • Directs and/or develops documentation to comply with QSR and CE guidelines, design documentation for the manufacture of product including drawings, product specifications and product validations, test protocol with research labs to complete required testing.
  • Establishes component acquisition plans to meet testing and project requirements.
  • Develop innovative processes in CAD to streamline design and production processes.
  • Communicate with customers, marketing and independent entities to gain knowledge into product design requirements.
  • Supervisory responsibility will be required.
  • Mentoring of engineering staff in product and technology requirements.
  • Other responsibilities as assigned.

Qualifications:

  • BS in Mechanical Engineering or equivalent degree. MS in Engineering a plus.
  • Minimum of 8+ years of product development experience.
  • Minimum of 6+ years of experience in Orthopedics or other implantable medical products.
  • Experience leading a new product from concept through release.
  • Demonstrated ability to monitor the work of direct reports to ensure quality, accuracy and thoroughness.

Skills, Abilities, and Competencies Required:

  • Excellent written and verbal communication skills; able to communicate effectively and appropriately with internal and external stakeholders.
  • Able to work independently as well as part of a team; demonstrated experience building a strong team environment.
  • Able to excel in a high-pressure, fast paced, and ever changing environment; adapt to frequent changes, delays, or unexpected events while meeting objectives, budgets, and timelines.
  • Strong interpersonal skills and maturity in working with all levels of the organization.
  • Strong knowledge of Orthopedic hip surgical procedures and associated user needs, Orthopedic manufacturing methods, strong background in FEA and CAD/CAM, Rapid prototyping.
  • Understanding of packaging and sterilization systems as related to medical devices.
  • Understanding of the orthopedic marketplace.
  • Must excel in high pressure environments with aggressive deadlines; meet project objectives, budget and timelines.
  • Strong people management skills.

ConforMIS is an Equal Opportunity Employer

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