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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:
  1. Design for manufacturability and reliability
  2. Design, development and support of commercial products
  3. SolidWorks (CAD design)
  4. Test method development and execution
  5. Knowledge of statistical methodologies
  • Preferred Technical Expertise:
  1. Manufacturing methods and their selection
  2. Knowledge of injection molded part design
  3. Knowledge of extrusion process and part design
  4. Knowledge of Design for Manufacturing/Assembly methodologies
  5. Root-cause analysis and failure investigation
  • Other Essentials and Key Success Factors:
  1. Demonstrated record of intellectual curiosity, innovation and creative problem solving with an entrepreneurial spirit
  2. Ability to lead fast-paced projects with a keen sense of urgency to get the job done well
  3. Evidence of "hands-on" experience and expertise
  4. Proven and successful track record as a team-player and collaborator in small working environments
  5. Highly organized and detail oriented with a passion to deliver quality results
  6. Excellent verbal and written communication skills, with experience translating technical concepts into user-friendly documentation
  7. 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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