Staff Engineer for Medical Device Development

18 hours ago

Brockton, Massachusetts, United States BD Full time
Job Description Summary

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.
  • 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.

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