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Staff Engineer for Medical Device Development

2 months ago

Trenton, New Jersey, United States BD Full time
Job Description

We are seeking a highly skilled and experienced Staff Engineer to join our dynamic Medical Delivery System new product development design team.

The ideal candidate will have a strong background in Mechanical Engineering, Biomedical Engineering, or Chemical Engineering, with a focus on medical devices or pharmaceuticals.

Responsibilities:
  • Lead the design and development of innovative medical devices.
  • Apply mechanical engineering theoretical principles and techniques to understand, develop, and design innovative solutions to complex technical challenges.
  • Collaborate with cross-functional team members to develop and evaluate technology solutions that address prioritized unmet needs.
  • Conduct research to identify new technologies and methodologies.
  • Drive technical research to understand customer and clinical needs, develop insights and recommendations through scientific literature review, technology landscaping, and ethnographic research.
  • Design, fabricate device embodiments for use in concept usability/simulated use studies.
  • Identify the best tools and approaches to develop/optimize device and system designs using an appropriate mix of first principles / analytical, computational, and experimental methods.
  • Translate clinical needs into device requirements, system architectures, and realistic and actionable design plans.
  • Demonstrate excellent understanding of medical device product development including risk management methodologies.
  • Develop and execute test methods and implement data acquisition systems, assembly methods, tooling, equipment, and processes for devices intended for bench, ex vivo, preclinical and simulated use evaluations.
  • Lead and conduct data and statistical analysis efforts of experimental results to generate conclusions and drive project direction.
  • Communicate relevant project information effectively (verbal and written) including project status, technical concepts and design details, and functional demonstrations to key internal and external stakeholders of varying technical abilities.
  • Provide technical expertise and mentorship to junior engineers and team members.
  • Oversee the implementation of engineering principles in the production process.
  • Ensure compliance with industry standards and regulations.
  • Publish research findings in peer-reviewed journals and present at conferences.
Requirements:
  • Degree in mechanical, biomedical or chemical engineering.
  • Experience: PhD + minimum of 4 years of medical device or pharmaceutical industry experience, MS + minimum of 8 years of medical device or pharmaceutical industry experience, or BS + minimum of 14 years of medical device or pharmaceutical industry experience.
  • Experience serving as an engineering lead to conceptualize, design, and develop medical devices that address clinical needs.
  • Proven track record of active communication and influencing without authority.
  • Strong analytical and problem-solving skills.
  • Excellent project management abilities.
  • Proficient in the use of Solid Works, Minitab or other statistical software, and other relevant engineering software.
  • Demonstrated track record of peer-reviewed publications and patents.
  • Experience presenting at conferences.
Preferred Qualifications:
  • Ph.D. in Mechanical Engineering, Biomedical Engineering, or Chemical Engineering is preferred.
  • Experience with FDA regulations and ISO standards.
  • Proven ability to lead and manage a team.
  • Excellent written and verbal communication skills.

BD 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.