Job Description SummaryThe Product Development Lead Developer'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 Responsibilities 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. + 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 8 years of post-educational professional experience Desired Qualifications: + Graduate degree (MS or Phd) in Mechanical Engineering, Biomedical Engineering or similar + 10+ years of post-educational experience in Medical Device Design Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status. #LI-Pro # Primary Work LocationUSA NJ - Franklin Lakes # Additional Locations # Work Shift Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.