Senior R&D Engineer

Position Summary

Reporting to the Engineering Manager, the Senior R&D Engineer works in a small, cross functional team of capable and experienced engineers who are working to develop a novel therapeutic system that includes both capital equipment and disposable components. Working with our team, this position is ideal for those seeking a unique opportunity to design the next generation of medical device products in a fast paced, dynamic and mission focused company. With skills and experience in development of single use disposable products, the R&D Engineer works closely with Fractyl Stakeholders to develop, test, and introduce superior, highly effective, and safe products. The R&D Engineer brings to Fractyl hands-on experience with designing and testing single use disposable catheter and other medical products.

Primary Responsibilities

• Perform design and product development duties on catheters & components to support existing and future generation products.
• Provide thorough and systematic root cause analysis expertise across the product development life cycle.
• Perform verification and validation testing including test method and fixture development, test execution, documentation and write-up/analysis of results.
• Conduct design reviews, effectively communicate and collect feedback on the impact of design changes throughout the stages of product development.
• Work with key clinicians and industry thought leaders to ensure understanding of the clinical needs and capture optimal product design concepts from the onset and on a continuous basis.
• Develop design specifications and acceptance criteria. Contribute to risk analysis and implementation of risk mitigations.
• Develop successful vendor relationships, including design consultants and medical device manufacturers.
• Develop, implement, and optimize design in relation to manufacturing processes and methods in accordance with product specifications and quality standards.
• Participate in the development of patents and other intellectual property related to company products.
• Work within company Quality System to coordinate design changes and documentation.
• Perform all activities in compliance with applicable regulations, Fractyl’s policies and guidelines, including, but not limited to, timely documentation of activities and maintaining all required applicable training.
• Develop and maintain relevant professional / technical knowledge through educational workshops/conferences; professional publications; professional networking; professional societies (Where applicable).
• Perform all activities in compliance with applicable regulations, Fractyl’s policies and guidelines, including, but not limited to, timely documentation of activities and maintaining all required applicable training. 
• Bring a “can do” spirit to work and deliver on other responsibilities as assigned.

Education or Certification Requirements

• Bachelor’s or Master’s degree in mechanical/biomedical engineering
• Professional Work Experience
• Minimum of 5 years hands-on experience in new product research and development in a regulated industry (work experience in the Medical Device field preferred)
• A preference for a candidate with experience with developing medical devices through commercialization; including design for cost of goods and manufacturing.  Experience with high volume medical device (e.g., catheter) manufacturing a plus.
• A preference for a candidate with experience in catheter based technology (extrusions, molding, novel bonding techniques).
• Experience in single use disposable manufacturing process development, validations, and qualifications.

Qualifications and Skills

• To perform this job successfully, you need to possess superb skills relevant to the medical product development life cycle and bring to the team a desire to design and develop such products toward commercialization. A combination of requirements and preferences listed below represent the knowledge, skills, and/or abilities that the successful candidate needs to possess.

 Required Technical Expertise:

• Design, development, and support of commercial products
• SolidWorks (CAD design)
• Test method development and execution
• Knowledge of statistical methodologies
• Design for manufacturability and reliability

Preferred Technical Expertise:

• Manufacturing methods and their selection
• Knowledge of injection molded part design
• Knowledge of extrusion process and part design
• Knowledge of Design for Manufacturing/Assembly methodologies
• Root-cause analysis and failure investigation

Other Essentials and Key Success Factors:

• 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

Travel

• Be able to travel nationally and internationally to a certain capacity.

The description and requirements outlined above are general; additional requirements may apply.