Senior Mechanical Engineer - Catheter
- Employer
- Fractyl Health
- Location
- Lexington, Massachusetts
- Start date
- Sep 9, 2021
View more
- Discipline
- Engineering, Mechanical/Manufacturing Engineer
- Required Education
- Bachelors Degree
- Position Type
- Full time
- Hotbed
- Genetown
Position Summary
Reporting to the Engineering Manager, the Senior Catheter / Mechanical 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 Catheter / Mechanical Engineer works closely with Fractyl Stakeholders to develop, test and introduce superior, highly effective and safe products. The Catheter / Mechanical Engineer brings to Fractyl hands-on experience with designing and testing single use disposable products, catheter design experience a plus.
Primary Responsibilities
- Perform design and product development duties on catheters & components to support existing and future generation products.
- Develop, implement, & optimize manufacturing processes and methods in accordance with product specifications and quality standards.
- 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 catheter manufacturers.
- 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
- 5+ years hands-on experience in new product research and development in a regulated industry (work experience in the Medical Device field preferred)
- Experience with developing medical devices through commercialization; includes design for cost of goods and manufacturing. Experience with high volume catheter manufacturing a plus.
- A preference for a candidate with experience in catheter based technology (extrustions, molding, novel bonding techniques).
- Experience in single use disposable manufacturing process development, validations and qualifications.
- 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
- 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 for manufacturability and reliability
- Design, development and support of commercial products
- SolidWorks (CAD design)
- Test method development and execution
- Knowledge of statistical methodologies
- 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.
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