Reports to: Sr. Engineering Manager
The Sr. Systems Engineer is responsible for designing and developing all levels of complex medical systems and products. S/he conducts research and data analysis to bring together knowledge from many technical sources and leads the basic algorithm development. The Engineer assesses biomedical systems, such as capital equipment, disposables, and software, for effectiveness, efficiency, safety, and usability. With hands-on experience, s/he leads cross-functional teams in human-factors engineering practices and ensures compliance with IEC 62366. The Engineer develops processes in line with the medical procedures and actively maintains them on an ongoing basis. S/he creates and maintains design documentation and training materials, conducting training with internal and external teams as assigned.
- Identify and prioritize essential requirements for successful system-level design with internal and external stakeholders.
- Guide development teams to translate system level requirements into product architecture and system level designs, including, but not limited to, partitioning functionality into sub-systems, creating requirements and specifications for each sub-system and documenting the interface requirements among the sub-systems.
- Manage the Usability Engineering process with product development teams.
- Build and maintain the Usability Engineering File, and manage the efforts of cross-functional team members for deliverables.
- Manage the product validation process, inclusive of protocol and method development.
- Evaluate sensor systems and develop algorithms that ensure safe operation of the system before and during use.
- Create internal data collection, storage, and analysis processes for blinded clinical trials, turning product and procedure data into actionable insights.
- Regularly report key procedure / clinical metrics to senior management to drive decisions and progress related to the procedure and clinical sites.
- Plan, author, and execute pre-clinical protocols with IACUC approval.
- Conduct clinician training programs, ensuring procedure safety and consistency at clinical trial sites.
- Mentor or supervise less-experienced employees and engineering co-ops.
- Contribute to product development programs with a results-oriented, can deliver attitude using hands on engineering.
- Ensure compliance with Design Control regulations and requirements, including, but not limited to, specification development, risk analysis, and verification and validation protocols and reports for all contributions made to Fractyl projects.
- Bring a “can do” spirit to work and deliver on other responsibilities as assigned.
Education or Certification Requirements
- Master's Degree in electrical, biomedical or mechanical engineering, or Bachelor’s and equivalent work experience
Professional Work Experience
- 5+ years of engineering experience in research and product development
- Experience analyzing large data files and working proficiency with a scripting language preferred.
- Experience in biotech, pharmaceutical and/or medical device industries in pre-clinical and clinical settings preferred.
- Prior vocational experience in related fields a plus (i.e. Co-Ops, Internships, Fellowships, etc.).
Qualifications and Skills
- Working knowledge of IEC 62366 and FDA guidance on Usability Engineering in Medical Devices
- Statistical software proficiency preferred.
Other Essentials and Key Success Factors:
- Successful track record of working in high-growth and dynamic organizations
- Demonstrated record of intellectual curiosity, innovation and creative problem solving with an entrepreneurial spirit
- Ability to lead fast-paced projects with a keen sense of urgency to get the job done well
- Evidence of "hands-on" experience and expertise
- Proven and successful track record as a team-player and collaborator in small working environments
- Highly organized and detail oriented with a passion to deliver quality results
- Excellent verbal and written communication skills, with experience translating technical concepts into user-friendly documentation
- Highest levels of professionalism, confidence, personal values and ethical standards
- Will be required to travel up to 10% globally.
The description and requirements outlined above are general; additional requirements may apply.