Director, Design Engineering

Job Summary:

The Director, Design Engineering will be responsible for the development of new products and processes for orthopedic joint implant and instrumentation products. Requires a familiarity with a variety of manufacturing concepts, practices, and procedures, particularly related to metalworking, packaging, and sterilization.

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.
  • Researches, evaluates, and recommends investments in production technology, capital equipment and systems to improve process efficiencies and product quality.
  • Establishes the information and reporting to evaluate manufacturing performance and capacity plans in the context of increasing sales forecasts and evolving product lines.
  • Determines resource needs, develops plans, tracks progress to those plans, resolves conflicts and delivers scheduled milestones to projects.
  • Collaborates with Research & Development and Operations to develop schedules, project plans, and cost estimates for implementing new product introductions and significant product enhancements.
  • Reviews and evaluates product quality, cost effectiveness and manufacturing performance to standards and takes action as necessary to correct variances.
  • Mentors less experienced staff on technical issues and handling projects and responsibilities; considered a strong leader and role model for the engineering department.
  • Ensures design engineers follow appropriate design history file guidelines per FDA requirements and hold design reviews in accordance with product development procedures.
  • Leads team in developing, validating, and documenting product and process requirements.
  • Work with senior management in the prioritization and assessment of future projects and company and department goals.
  • Other responsibilities as assigned.

Qualifications:

  • Strong project management skills required. Capable of overseeing multiple cross-functional teams in all project activities for multiple concurrent projects necessary for the successful commercial launch of new products.
  • Comfortable driving multiple initiatives at a rapid pace, making thoughtful recommendations with available data.
  • Active, high-energy communicator who drives a company vision/mission to align teams, critical resources, management, and stakeholders.
  • Demonstrated track record of developing and launching successful, innovative medical products; has a thorough understanding of a variety of manufacturing processes and how they affect design decisions.
  • Proven experience in Lean Process Implementation.
  • Familiar with mainstream competitive products and procedures.
  • Demonstrated ability to develop business, operational and financial strategies, plans and programs that foster and achievement of organizational objectives.
  • Experience in technical report writing and verbal and oral communication skills.
  • Bachelor’s Degree in Mechanical Engineering or equivalent is required. Master’s Degree in Engineering or Material Science is preferred.
  • Comfortable driving multiple initiatives at a rapid pace, making thoughtful recommendations with available data.
  • Active, effective communicator who drives a company vision/mission to align teams, critical resources, management and stakeholders.
  • Direct and write the documentation to comply with QSR and CE guidelines.
  • Communicate with customers, marketing and independent entities to gain knowledge into product design requirements.
  • Develop test protocol with research labs to complete required testing.
  • Establish component acquisition plans to meet testing and project requirements.
  • Direct and/or develop design documentation for the manufacture of product including drawings, product specifications, and product validations.
  • Develop innovative processes in CAD to streamline design and production processes.

Skills, Abilities, and Competencies Required:

  • Able to monitor the work of direct reports to ensure quality, accuracy and thoroughness.
  • Excellent written and verbal communication skills; able to communicate effectively and appropriately with internal and external stakeholders.
  • Willingness to make decisions; builds commitment for decisions and overcomes resistance from others.
  • Able to work independently as well as part of a team; demonstrated experience building a strong team environment.
  • Demonstrated original thinking and able to generate creative solutions; identifies and resolves problems in a timely manner.
  • Able to excel in a high-pressure, fast paced, and ever changing environment, adapts to frequent changes, delays, or unexpected events while meeting objectives, budgets, and timelines.
  • Computer engineering system including FEA and CAD/CAM.
  • Packaging and sterilization systems.
  • Demonstrated ability to create concepts from brief customer requirements.
  • The ability to predict market trends and create solutions to meet demands.
  • Demonstrated ability to meet project objectives and timelines.
  • Demonstrated ability to adapt quickly to changes in a fast-paced environment.

ConforMIS is an Equal Opportunity Employer

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