Be part of something bigger at BD. Here, you’ll join a driven, agile engineering team working in a startup-like environment that has the backing and resources of a Fortune 500 company. In engineering, you could be involved in everything from operations, production and construction to information technology and maintenance environments, all while analyzing and developing solutions to further our engineering capabilities. You’ll use your talent and track record of solving complex problems to achieve one singular goal: advancing the world of health™. At BD, you can make a true difference of one.
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.
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.
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.
Bachelor’s degree in Mechanical Engineering, Biomedical Engineering or similar
Minimum of 8 years of post-educational professional experience
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.
Primary Work LocationUSA NJ - Franklin Lakes
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Advancing the world of health™
BD is one of the largest global medical technology companies in the world and is advancing the world of health™ by improving medical discovery, diagnostics and the delivery of care. BD helps customers enhance outcomes, lower costs, increase efficiencies, improve safety and expand access to health care.
As a new employee what I like most about BD are the many learning and professional developmental opportunities for growth offered. It is good to know that there are so many resources to choose from.
Since joining BD, I really have liked the people I work with on a daily basis and the collaboration towards common goals.
Senior Program Manager
BD is full of passionate, loyal, and driven people that have a common goal of advancing healthcare without sacrificing quality or service.