Careers

     

 Contact

     

 877-639-2673

Program Manager – Rochester, NH

Medical Device Manufacturing Jobs

Growing contract manufacturer for single use, disposable medical devices is looking for a dependable individual to join our team. The Program Manager should be a self-driven team player who has strong organizational and communication skills. This position reports to the Vice President of Engineering.

 

Responsibilities

  • Manage technical projects as assigned involving complex disposable medical products with total responsibility in program success and maintaining a high level of customer satisfaction
  • Support the quotation process by developing engineering NRE activities list and estimating costs
  • Development of project timeline and managing of project tasks ensuring deliverables to the customer are on time and on budget
  • Maintain accuracy of time sheets and billable tasks against the project for customer invoicing
  • Produce results and meet milestones in a resource challenged environment
  • Minimize project conflicts and challenges with customer, but resolve should they occur
  • Must have demonstrated effectiveness in prioritizing tasks and managing multiple priorities
  • Lead and/or assist in the development of documentation required under Design Control requirements as determined by the customer or Next Phase Product Development SOP’s, including but not limited to;
    • Product Drawings and Specification (component, sub-assembly, final assembly)
    • Control Plans
    • Master Validation Plan, Validation Protocols and Reports
    • Risk Assessments, Hazard Analysis, DFMEA, PFMEA
    • Test Procedures and Reports
    • IQ/OQ/PQ documentation
    • Manufacturing Assembly Instructions
    • Labeling
  • Conduct analysis of raw data and develop statistical analysis with appropriate conclusions
  • Develop Calibration and Preventive Maintenance programs for equipment supporting project
  • Manage, review and approve product design changes
  • Consult and negotiate with customers on all product design specifications and any product or project scope changes
  • Must maintain training to all current Next Phase Quality Documents, including the Quality Manual and all SOP’s as assigned
  • All other duties as assigned

Requirements

  • Familiarity and prior experience working under ISO 13485:2016, ISO 14971:2007, 21CFR Section 820 (FDA QSR)
  • Previous work experience in a contract manufacturing environment with strong business acumen preferred
  • Use of statistical software, Minitab preferred
  • Proficient in Microsoft Office Suite (Word, Excel, PowerPoint, Project), Visio and CAD software (SolidWorks preferred)
  • Must be a self-starter requiring minimal direction
  • Previous experience and proficiency in Design Control under 13485 and FDA QSR requirements

Experience

  • Bachelor of Science degree in an engineering discipline required
  • 7-10 years in the medical device industry with a proven track record of successfully managing projects involving development of new medical device disposable products with successful migration to manufacturing
  • Must have demonstrated success in project management and new product introductions into a cleanroom environment
  • Project Management certification (PMP, PMI-ACP, SMC, SAFe, SA) desired

Benefits

  • Competitive benefits offered; However, NextPhase Medical does not offer relocation packages.

Unsolicited, Non-Contracted Agencies not subject to “finder’s fee”

START YOUR APPLICATION