Auris Health, Inc. is recruiting for a Sr. Manufacturing Engineer, This position will be located in Redwood City, CA.
Auris Health, Inc., part of the Johnson & Johnson family of companies, is transforming medical intervention. By combining advancements in medical robotics, instrumentation, navigation and data science, Auris is building a platform technology capable of expanding the applicability of robotics to a spectrum of medical procedures. Learn more about Auris Health at https://www.aurishealth.com/.
As a Sr. Manufacturing Engineer, the individual participates in product development phases as manufacturing engineering liaison. The position will be responsible to assess and provide design for manufacturing (DFM) input to the product design team, and responsible to design and deploy manufacturing fixture and tooling, develop manufacturing processes, establish manufacturing procedures, and lead process validation and design transfer to manufacturing internally or externally.
Core Job Responsibilities:
- Design, document, qualify and release manufacturing process and assembly equipment, fixture and process aids.
- Conduct process DOE to optimize process windows and perform process capability analysis.
- Provide product and process DFM (Design for Manufacturing) input to product development core team to enhance manufacturability and reduce product cost.
- Develop and set up manufacturing assembly line, release and/or refine BOMs, work flow processes and detailed MPI work instructions.
- Create required documentation to support the development of products and manufacturing processes. Lead process validation activities, including timelines, responsibilities, and validation protocols/reports.
- Leads or participates in pilot production or production phase, resolve manufacturability issues, and drive improvements in yield and efficiency through lean manufacturing, fixture/tooling design or automation.
- Provide training to production staffs for assembly, testing, and the use of released equipment, methods and procedures.
- Support manufacturing team in maintaining compliance with medical device quality system requirements, including corrective/preventive action closure, disposition of non-conforming materials, and etc.
- Perform failure analysis for discrepant production components, assemblies or field returns, and troubleshoot manufacturing line issues.
- Other manufacturing engineering duties or support as assigned or requested.
Required Knowledge/Skills, Education, And Experience
BS degree in Mechanical, Industrial, Chemical, Biomedical, Materials Engineering or equivalent experience is required.
BS/BA and 5+ years or MS and 3+ years of experience designing and engineering manufacturing processes, supporting new product introductions or pilot production lines required.
Strong technical skill in materials, process development, BOM structure and best practice for flexible instrument or catheter devices preferred.
Strong knowledge and hands on experience with process validation planning/execution, IQ/OQ/PQ protocols and reports preferred.
Strong knowledge and experience in creating PFMEA, process control plan, SPC, or other statistical analysis tools for MFG assembly lines preferred.
Agile PLM experience is preferred
Ability to manage multiple priorities in fast-paced environment.
Prior experience in medical device or other highly regulated industry is preferred.
Excellent Project Management skills. Experience in Agile product development is a plus.
Excellent knowledge of 21 CFR part 820 and ISO 13485
Working knowledge in Solidworks, prototyping, tooling/fixture development is a plus
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer.
Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
United States-California-Redwood City-
Auris Health, Inc. (6267)