Company Description:

RefleXion Medical is on a mission to create a new cancer treatment modality through biological guidance. By leveraging positron emission tomography (PET) in a novel way, RefleXion’s patented technology causes tumors to continuously signal their location during treatment, potentially revolutionizing cancer care.

We’re passionately committed to making dramatic changes to cancer care, and we believe that small, lean teams of brilliant people are the only way to do that. We need teammates with both the foresight and experience to avoid roadblocks, and the drive and creativity to steer around those that inevitably appear. We seek those who will unabashedly and relentlessly help us create a new modality in cancer care.

If you are bold and inventive – we want you.
If you combine passion with experience – we want you.
If you embrace iteration and constant learning – we want you.

Come and join a company on an incredible and meaningful mission.

Job Description:

The Manager of New Product Introduction (NPI) leads a team responsible for providing a smooth transition of new products from design to manufacturing.   This team will coordinate requirements, verification and validation testing activities during design and generates the initial manufacturing process controls during the transition from design to manufacturing.  The successful candidate will be a strong functional leader and motivator and will be expected to project manage both internal and external test efforts. He or she must possess a deep familiarity with quality system standards and have prior experience in the manufacture and test of complex mechanical, electrical and software systems. The NPI team will work closely with engineers in a variety of other disciplines to understand design requirements and test strategies for systems as complex as positron-emission sensing and radiotherapy x-ray generation. The Manager must possess the ability to teach and train others in the art of medical device quality systems and design control, including specification, risk analysis, and formal testing. He or she will engage the team on any and every issue necessary to ship products to customers of the highest quality and reliability.

Roles and Responsibilities:

  • Functional management of the RefleXion NPI team
  • Tight integration of NPI activities with overall development program management
  • Project management and coordination of the assembly and test of prototype units
  • Identification and resolution of design improvements for reliability, manufacturability and serviceability
  • Coordination and scheduling of resources required to efficiently utilize prototype units and bunkers during Design V&V testing
  • Technical review and feedback during design reviews, risk assessments, test plans and other Design Control deliverables
  • Organizing, managing and reviewing system verification and validation testing sufficient to support a 510(k) submission and clearance
  • Project management of design development projects with key suppliers
  • Organizing, managing and reviewing the development of efficient and high quality production processes 

 Skill/Job Requirements:

  • Engineering Bachelor’s degree, Master’s or above preferred
  • 5+ years of experience with complex, multi-disciplinary medical device design.  Prior experience with either radiotherapy or medical diagnostic systems preferred.
  • 3+ years of experience in a functional management role
  • 3+ years of experience with project, planning and change management
  • Demonstrated ability to inspire and lead other engineers by technical example
  • Significant experience with vendor interactions, for both piece-parts and complex assemblies
  • Some experience with software test methodologies highly desirable
  • Deep understanding of medical device design control concepts such as design input, design output, traceability, risk analysis, and V&V testing
  • Regulatory agency experience including UL, CE and FDA approval processes
  • Excellent communication skills across all levels of the organization
  • A passion for creating robust and reliable products

 

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