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Project Manager

Apply Now Job ID R-325785 Date posted 12/17/2018

Job Description Summary

Within BD Preanalytical Systems (PAS), the PMO is looking for a highly talented and driven individual with a passion and proven track record for product development and engineering. The incumbent will provide leadership to a large cross-functional team responsible for executing on a diverse portfolio of projects in support of sustaining engineering including line extensions, continuous improvement, capacity expansion, supply continuity, global compliance & remediation, and customer support.

Job Description

The role will require cross-functional leadership, influencing and negotiation skills, and project/program management proficiency in addition to the ability to directly lead associates in project execution. More specifically, your responsibilities may include:

  • Lead a cross-functional team, including R&D, Quality, Regulatory, Medical, and Manufacturing resources in managing and executing projects in support of global medical products.
  • Lead and support execution of technical and/or cross-functional project work
  • Support the portfolio of current products in terms of quality and regulatory compliance, manufacturing, and supply continuity
  • Ensure implementation and rigor of product development processes and design control procedures
  • Demonstrate strong and clear accountability for operational and program success
  • Demonstrate leadership, learning agility, and action orientation when facing uncertainty. Instill confidence through leadership and actions
  • Motivate the team to achieve individual and program objectives
  • Foster the development of team members to excel in their performance, both functionally and cross-functionally
  • 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.
  • Ensure compliance with BD quality policies, procedures, and practices
  • Ensure compliance with all local, state, federal, and BD safety regulations, policies, and procedures

Requirements

  • Minimum of 6 years experience as a product development engineer or program 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 a structured, phase-gated, product development process;
  • Demonstrated experience in a technical leadership role on a cross-functional team;
  • Demonstrated experience with all phases of the Design Control process;
  • Demonstrated understanding of the requirements management process  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;
  • Experience with design optimization for multi-component mechanical assemblies or systems involving injection molded and compression molded components;
  • Understanding of fixture design including basic machining considerations, Measurement Systems Analysis (MSA)
  • Proficiency with statistical techniques and experience utilizing statistical analysis software (e.g. Minitab);
  • Proficiency in Microsoft Project or equivalent project planning software;
  • Basic understanding of intellectual property (IP) considerations;
  • Strong analytical and problem-solving skills;
  • Demonstrated ability to clearly and effectively communicate (verbal & written) concepts; and
  • Good understanding of business / finance concepts (e.g., payback, rate of return, cashflow, income statement)

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Primary Work Location

USA NJ - Franklin Lakes

Additional Locations

Work Shift

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All applicants should complete the on-line application process. BD is committed to working with and providing reasonable accommodations to individuals with disabilities. If you require assistance or an accommodation because of a disability to participate in the application process, please call 855-BD-HELPS (855-234-3577) or email asc.americas@bd.com