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Sr. Manufacturing Engineer, Instrument Sustaining/Lifecycle Management

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Job Description


Auris Health Inc., part of the Johnson & Johnson family of companies, is recruiting for a Sr. Manufacturing Engineer, Instrument Sustaining/LCM, 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 sustains and improve the current production line as manufacturing engineer. The position will be responsible to improve yield and cycle time of current and future products, and responsible to design and deploy manufacturing fixture and tooling, develop manufacturing processes, establish manufacturing procedures, and lead or perform process validation and design transfer to manufacturing internally or externally.


Job Responsibilities:

• Develop, evaluate, and improve manufacturing assembly and test methods to ensure consistent quality and efficiency of manufactured products.

• Improve manufacturing processes and methods for cost-reduction, quality improvement, and efficiency.

• Develop and perform process validation for manufactured products and associated assembly equipment, test equipment, and processes including the development of protocols, procedures, and reports as necessary.

• Provide labor capacity and space requirement estimates for the establishment and maintenance of new and existing manufacturing lines.

• Troubleshoot process problems and identifies solutions that reduce downtime and conserve maintenance costs.

• Manufacturing process instructions (MPI) generation and implementation; verify builds process, visual aids, work instructions, and ensure templates are kept up-to-date.

• Identify opportunities for automation, and either develop or work with an outside resource to implement.

• 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.

• This position operates in a professional office environment. 

• This role routinely uses standard office equipment such as computers, phones, and photocopiers.

• While performing the duties of this job, the employee is regularly required to talk or hear. 

• The employee frequently is required to stand, walk; use hands to finger, handle or feel; and reach with hands and arms.

• This is a full-time position. 

• Days and hours of work are flexible Monday through Friday, generally 8:30 a.m. to 5:30 p.m. 

• Occasional evening and weekend work may be required as job duties demand.


Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.



Qualifications

Required 

Bachelor’s Degree in Mechanical, Industrial, Chemical, Biomedical, Materials Engineering or equivalent experience 

• 5 years’ experience as design or manufacturing engineer supporting product or production lines. 

OR 

• Master’s Degree with 3 years’ experience.

• Strong technical skill in materials, process development, BOM structure and best practice for flexible instrument or catheter devices.

• Strong knowledge and hands on experience with process validation planning/execution, IQ/OQ/PQ protocols and reports.

• Strong knowledge and experience in creating PFMEA, process control plan, SPC, or other statistical analysis tools for MFG assembly lines.

• Ability to manage multiple priorities in fast-paced environment.

• Excellent knowledge of 21 CFR part 820 and ISO 13485.

 

Preferred: 

• Advanced Degree 

• Prior experience in medical device or other highly regulated industry. 

• Excellent Project Management skills. 

• Experience in Agile product development.

• Working knowledge in Solidworks, prototyping, tooling/fixture development. 

• Agile PLM experience. 



Primary Location
United States-California-Redwood City-
Organization
Auris Health, Inc. (6267)
Job Function
Not Mapped
Requisition ID
7305191009