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Sr. Program Manager, Product Lifecycle Management

Apply Now Job ID R-355258 Date posted 12/12/2019

Locations

Franklin Lakes, New Jersey

Job Description Summary

Reporting to the Director of Program Management, Specimen Management within the Integrated Diagnostic Solutions Business Unit, the Product Lifecycle Management Team Leader will drive execution of a dynamic and complex project portfolio, aimed at supporting existing product lines. This person will lead a cross-functional team to prioritize, scope, plan and execute all sustaining engineering projects for the WW Specimen Acquisition business line in categories such as supply continuity, capacity expansion, cost reduction, product quality improvements, line extensions, and customer support. This role will also work closely with the Business Line Leader to identify and implement solutions to improve specimen management within the existing portfolio, maintaining customer focus and ensuring consistent delivery of a high quality product for accurate downstream clinical testing.

Job Description

  • Lead design and development activities for all products within the current Acquisition product portfolio (blood collection needles, wingsets, transfer devices, lancets), supporting growth of the Vacutainer® Product Line

  • Support all current products in terms of quality, manufacturing, supply continuity and cost improvement.
  • Utilize depth and breadth of cross-functional knowledge to assess project scope, possible execution strategies, and cross-functional resource needs.
  • Facilitate ongoing project prioritization process within Platform Team, weighing scope versus impact
  • Ensure timely resolution of CAPAs, specification deviations, and customer-related field issues
  • Maintain prioritized list of projects for WW Acquisition & Emerging Specimen Management Business Lines including resource allocation tracking
  • Lead execution of cross-functional project work including collaboration with external vendors and manufacturing facilities.
  • Embed practices within the team to drive improved execution efficiency
  • Engage with external customers and key stakeholders to gain insights into product performance, conduct root cause analysis, perform technical assessments, and gain feedback regarding product improvements.
  • Maintain ongoing communication with business and functional leadership
  • Contribute to a culture of innovation by proactively generating novel concepts to improve current product performance or enhance current products' ability to address customer needs.
  • Provide training and mentorship to junior engineers and assist in assessing their performance.

Requirements

  • Minimum of 10 years combined experience as a product development engineer and/or project manager in the medical device or other regulated industry (experience with FDA class II or III medical devices preferred);
  • Bachelor's Degree in a technical field required.  Master's Degree in technical field and/or MBA preferred. 
  • Demonstrated experience leading cross-function teams to complete product changes through all phases of Design Control;

Additional Preferred Req'ts:

  • Demonstrated experience in a technical leadership role on a cross-functional team
  • Demonstrated understanding of the requirements management process, with demonstrated experience in developing design inputs, design verification strategy and implementation;
  • Demonstrated understanding of medical device product development risk management methodologies;
  • Experience with designing for high-volume manufacturing methods such as injection molding, and automated assembly and packaging processes;
  • Demonstrated understanding of product development considerations for tightly controlled, high-volume manufacturing processes;
  • Clear understanding of manufacturing process validation including FAI/FAT, process development and IQ/OQ/PQ;
  • Proficiency in Microsoft Project or equivalent project planning software;
  • Strong analytical and problem-solving skills;
  • Demonstrated ability to clearly and effectively communicate (verbal & written) concepts; and

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Primary Work Location

USA NJ - Franklin Lakes

Additional Locations

Work Shift

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