Job Description Summary
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.
Responsibilities Strategy & Planning
Plan and execute medical device product development and commercialization utilizing a phase gate approach.
He/She will be an extended member of 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.
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
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
Graduate degree (MS or Phd) in Mechanical Engineering, Biomedical Engineering or similar
Primary Work Location
USA NJ - Franklin Lakes
NA (United States of America)