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Sr. Staff - Product Development Lead

Apply Now Job ID R-346980 Date posted 09/10/2019

Job Description Summary

The Product Development Lead’s role is to serve as the Lead and Key Technical Point of Contact (POC) for development projects. He/she will apply critical thinking and advanced knowledge of systems, reliability, risk management, industry standards, requirements, engineering principles and practices to support development projects.

He/She will be expected to interpret requirements and rationalize the design choices with the multi-disciplinary team, leverage quantitative approaches and knowledge of both mechanical design and manufacturing considerations in order to assess technical feasibility of various solutions.

Job Description


Strategy & Planning

  • Plan and execute medical device product development and commercialization utilizing a phase gate approach.
  • He/She is responsible for leading a team that has primary accountability for both the definition and management of requirements and for characterization of those systems/devices that leads to verification and validation.
  • Participates in Design and Technical Reviews to ensure customers’ needs are satisfied and designs are consistent with the system-level requirements.

Operational Management

  • Works closely with program managers and cross functional team members to ensure proper resourcing, expertise and functional support and to identify and mitigate technical issues to reduce programmatic risks.
  • Frequently interacts with senior functional leaders, including Marketing, Program Management, Operations, Quality, Business Platforms, Medical, and Regulatory to ensure that the system/device under development meets overall business needs.
  • Conduct bench studies, tolerance stack up analysis, FMEAs, design verification, validation, vendor interactions, materials specifications and component specifications.
  • Ensure compliance with BD quality policies, procedures, best practices; all applicable local, state, federal and BD laws and regulations.

Knowledge & Competencies

  • Proven experience in overseeing the design, development, and implementation of medical device systems, applications, and related products.
  • Excellent understanding of the organization’s goals and objectives.
  • Working knowledge of regulatory standards applicable to design of medical devices, including FDA QSR 21 CFR 820, ISO 13845, ISO 14971 and ISO 80369 and collateral standards
  • Expertise in common risk management techniques (FMEA).
  • Experience in modeling, simulations and sensitivity analyses.
  • Proficiency with basic statistical techniques including familiarity with analysis of variance (ANOVA) and design of experiment (DOE) methodologies.
  • Experience with design best practices, including advanced tolerance design, and design for reliability. 
  • Good project management skills.
  • Excellent written, oral, and interpersonal communication skills.
  • Ability to conduct research into systems issues and products as required.
  • Ability to communicate ideas in both technical and user-friendly language.
  • Highly self-motivated and directed, with keen attention to detail.
  • Proven analytical and creative problem-solving abilities.
  • Ability to work in a team-oriented, collaborative environment.

Minimum Qualifications:

  • Bachelor’s degree in Mechanical Engineering, Biomedical Engineering or similar
  • Minimum of 10 years of post-educational professional experience  

Desired Qualifications: 

  • Graduate degree (MS or Phd) in Mechanical Engineering, Biomedical Engineering or similar 
  • 15+ years of post-educational experience in Medical Device Design


Primary Work Location

USA NJ - Franklin Lakes

Additional Locations

Work Shift

NA (United States of America)
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