Fractyl is looking for a Senior Mechanical Engineer with experience in the development of single use disposable products. As a member of a small, cross functional team of capable and experienced engineers, together we will work on developing a novel therapeutic system that includes both durable and disposable components. The Senior Mechanical Engineer will be key contributing member on the full product life cycle from concept to commercialization. This includes, but is not limited to, product design and development for reliability, manufacturability, and cost of goods for the next generation medical device products. S/he will work closely with other teams such as Clinical Affairs, Manufacturing Operations, Quality & Regulatory Affairs, and Commercial, to meet product performance, quality, and cost goals, while optimizing time to market.
- Design, develop, and verify performance of novel medical devices that comprise both durable and disposable components.
- Develop design specifications, verification methods, and acceptance criteria.
- Perform and document complete product risk analysis throughout the life cycle of product development.
- Develop and execute design verification protocols.
- Develop and manage vendor relationships, including design consultants and component/assembly manufacturers.
- Conduct design reviews and effectively communicate and collect feedback on the impact and risks of design changes throughout the stages of product development.
- Participate in the development of patents and other intellectual property related to the company products.
- Guide and mentor junior team members on their projects, ensuring compliance with established Company procedures.
- Working with key clinicians and industry thought leaders, ensure understanding of the clinical needs and capturing optimal product design concepts from the onset and on a continuous basis.
- Coordinate design changes and documentation, working within the company’s ECO process.
- Bring a “can do” spirit to work and deliver on other responsibilities as assigned.
Education or Certification Requirements
- Bachelor’s degree in engineering required. Mechanical or Biomedical engineering preferred.
Professional Work Experience
- 4+ years of experience in new product research and development.
- Experience in biotech, pharmaceutical and/or medical device industries preferred.
- Prior vocational experience in related fields a plus (i.e. Co-Ops, Internships, Fellowships, etc.).
Qualifications and Skills
- Experience in catheter-based technology (extrusions, molding, novel/advanced bonding techniques) preferred.
- Experience with developing medical devices through commercialization, including design for cost of goods and manufacturing.
- Experience with single use disposables.
- Experience with single use disposable manufacturing process development, validations and qualifications.
- Successful track record of driving development of complex medical device projects, making risk-based decisions, and utilizing cross-functional team members to achieve various elements.
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
- May be required to travel globally on a limited basis and as needed.
The description and requirements outlined above are general; additional requirements may apply.