Sr. Process / R&D Engineer

Company: ReShape Lifesciences Inc.
Location: Irvine
Posted on: March 10, 2023

Job Description:

ReShape Lifesciences Inc. is America's premier weight-loss solutions company, offering an integrated portfolio of proven products and services that manage and treat obesity and metabolic disease. Our team is driven by a passion to help patients learn how to make long-term healthy living a part of their everyday lives. Our portfolio includes the FDA-approved Lap-Band - program, the investigational ReShape Vest--- System and the recently launched reshapecare--- virtual health coaching program.
Join us as we partner with clinicians to implement our innovative, non-invasive weight loss procedure and one-on-one support that helps inspire patients on their journey towards successful, long-lasting weight loss.


THE ROLE
ReShape Lifesciences has a fantastic opportunity for a Sr. Process / R&D Engineer to join our growing team. This role is responsible for being the project leader and technical liaison for all of the Company's manufacturing processes. Develop new product concepts and products. Project support includes overall design, requirement development, design for manufacturing, test method development, and product verification and validation testing.

The Sr. Process / R&D Engineer will work with suppliers and manufacturers to produce parts, own the design history file, support design phase reviews, and take on other responsibilities as needed. She/he must be able to apply engineering principles to perform design, fabrication, modification, and evaluation in support of manufacturing operations and will lead validations and qualifications of processes using statistical methods. The position will also work closely and partner with cross-functional teams to achieve Company objectives.WHAT YOU'LL DO

• Support the development of new or improve products with a hands-on approach, including writing or verifying specifications; designing new products and fixtures; testing processes and equipment; and specifying raw materials to ensure the concepts and/or prototypes meet specified requirements.
  
• Develop complex catheter system devices or mechanical devices, which will include developing design requirements, generating design concepts, hands-on prototyping, and design evaluation
  
• Works closely and provides technical support to third-party assembly house(s). Assists with product/manufacturing issues with third-party providers.
  
• Follows Company's design control procedure to conduct phase reviews and design reviews.
  
• Works closely with other R&D staff to transfer designs to manufacturing.
  
• Study specifications, engineering blueprints, tool orders, and manufacturing data and confer with engineering and manufacturing personnel to resolve design problems related to material characteristics, dimensional tolerances, service requirements, manufacturing procedures and cost
  
• Support or lead quality improvement initiatives such as process and product characterizations that lead to continuous / cost improvements.
  
• Conducts analysis and/or tests pertaining to the development of new methods, materials, processes, or standards and provides recommendations accordingly.
  
• Maintains working knowledge of product development elements, including specification development, failure analysis/root cause investigation, risk analysis/FMEA, DMFA and PFMA, statistics, process control, inspection methods, process validation, and test methods.
  
• Participates in product non-conformance process.
  
• Develops and executes IQs, OQs, PQs, and any other process qualification requirements.
  
• Supports ongoing supplier qualification and new supplier development.
  
  WHAT YOU'LL NEED
  

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• Minimum 5 years of work experience with catheter products and process development experience or equivalent working experience with electromechanical products
  
• Experience analyzing complex data and preparing reports, including Minitab
  
• Experience with SolidWorks
  
• Experience with IQs, OQs and PQs
  
• Ability to understand CAD/CAE drawings and schematics
  
  WHAT WE OFFER
  
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  • Hybrid work environment
    
  • Half-Fridays
    
  • Business casual dress code
    
  • Corporate-sponsored virtual team building events
    
  • Medical, dental, vision and life insurance
    
  • FSAs, HSAs, long-term and short-term disability
    
  • 401(k) plan
    
  • Employee assistance plan (EAP)
    
    
    
    #LI-HybridPI203589355

Keywords: ReShape Lifesciences Inc., Irvine , Sr. Process / R&D Engineer, Engineering , Irvine, California