Job Summary:

 

Conformal Medical is looking for a hands-on Sr. Development Engineer to lead (and support) new product development (NPD) programs from early concepts through verification/validation, manufacturing transfer, and product launch.  This position will report to the Sr. Director of Engineering.

 

The role will be in the thick of multiple projects and assignments.  You will use a wide variety of technical skills and reasoning to analyze mechanical systems, oversee and execute design and testing, improving product features and documenting findings.  This role is well suited for someone who thrives in small team environments, brings long experience in product design and associated process development, and has been a part of multiple product launches during their career.

 

You will have ownership, influence, and the opportunity to directly impact the success of life-changing medical technologies.  We are looking for someone who will take initiative, think critically, and work collaboratively with our team to deliver results.

 

Essential Functions / Job Responsibilities:

  • Excellent team-leading abilities and interpersonal skills are required for satisfying internal and external customers
  • Leadership qualities must include the ability to mentor colleagues and make critical judgements and decisions
  • Expected behavioral qualities include a positive outlook and affinity for teamwork, logic, innovation, initiative, influence, and self-sufficiency
  • This Sr. Development Engineer will be required to (at a minimum):
    • Demonstrate an ability to make critical judgements and decisions
    • Lead and support engineering projects
    • Demonstrate technical proficiency commiserate with the level of the role
    • Conduct analysis of physical systems (e.g. in terms of stress and strain, heat transfer, kinematics, etc.)
    • Design physical systems including products, fabrication tooling, and test fixtures.
    • Lead, coordinate, and conduct verification and validation testing
    • Maintain a modern understanding of new technologies, commercial fabrication techniques, etc.
    • Appropriate application of theory and commercial or custom software tools
    • Lead and support root cause investigations related to technical problems
    • Integrate academic and experiential knowledge in design and development solutions
    • Effectively and persuasively communicate work product to the entire organization

 

 

  • Lead NPD technical activities from concept through development, V&V, manufacturing, transfer, regulatory approval, and launch
  • Drive execution across multiple projects to meet critical milestones, identify risks and take action to resolve them
  • Ensure compliance with design controls and internal processes, including the creation and maintenance of project documentation such as:
    • Design History Files (DHFs)
    • Phase-gate and design review preparation and execution

 

 

Qualifications

  • Education: A bachelor’s degree is required (mechanical engineering or equivalent is preferred).
  • Experience: 7+ years of experience leading new product development projects in a regulated and cross-functional environment.  Medical Device experience is required.  Experience with at least one product launch is required.
  • Technical Skills: Strong technical fundamentals with the ability to adapt plans as conditions change.  Fundamental understanding or experience with technical fields including engineering and manufacturing to establish credibility with the cross-functional teams.
  • Leadership Skills: Excellent team-leading abilities and interpersonal skills.  A positive outlook and affinity for teamwork, logic, innovation, and initiative.
  • Problem-Solving: Excellent problem-solving and analytical skills with a demonstrated ability to make critical judgements and drive decision making within teams
  • Communication: Clear, confident communicator with a bias toward action and continuous improvement