Johnson & Johnson Careers
Principal NPI Engineer
Requisition ID: 1485190805
Auris Health, Inc. is recruiting for a Principal NPI 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 Principal NPI Engineer, the individual participates in all product development phases as manufacturing engineering liaison and strategist with an emphasis on flexible instrument product lines. At this level, it is expected the individual both leads projects and teams as well as performs as an individual contributor. This individual is an expert in their field and is passionate about inspiring others and taking responsibility to ensure projects are executed successfully. The position is embedded in R&D to work closely with design engineers, operations and contract manufacturers to enable excellence in rapid product development, and to ensure delivery of differentiating and innovative devices for robotic procedures. This role is the lead liaison between R&D design and operations, suppliers and contract manufacturers. This position is responsible for formulating manufacturing strategy across instruments and accessories. The position is responsible for assessing and providing design for manufacturing (DFM) input to the product design team, assessing, qualifying and managing component and contract manufacturers, managing development build plans and schedules, participating in builds, designing and deploying manufacturing fixtures and tooling, developing manufacturing processes, setting up manufacturing prototype and manufacturing lines, internal and external line transfers, establishing manufacturing procedures, leading process and mold validation.
Core Job Responsibilities:
Develop manufacturing strategies to minimize time to market and cost of novel medical devices.
Lead cross-functional teams to bring novel medical devices from initial design builds through full production. Collaborate with supply chain, R&D and quality to develop supplier landscapes to ensure supplier quality and launch readiness.
Oversee and lead complex manufacturing projects from individual component manufacturing through full device assembly.
Provide technical leadership to ensure new devices are optimally designed for manufacturability, and with acceptable manufacturing, inspection and testing processes.
Develop plans and milestones for manufacturing engineering and manufacturing deliverables to support and adhere to the program schedule.
Establish a reporting system that monitors project status and cost targets, and communicate them to the project team and upper management in a timely manner.
Plan and set up manufacturing pilot lines, work stations, process flow, and assure capacity (both manpower and facilities) and quality production of new products.
Provide mentoring and technical leadership to more junior engineers.
Remain current with advances in manufacturing and emerging technologies.
Represent Auris in trade and industry forums.
Design, document, qualify and release manufacturing processes and assembly equipment, fixture and process aids.
Develop, document and execute project plans.
Conduct process DOE to optimize process windows and perform process capability analysis.
Lead 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. Lines may be internal or external assembly lines.
Create required documentation to support the development of products and manufacturing processes. Lead process validation activities, including timelines, responsibilities, and validation protocols/reports.
Lead mold validation activities, including timelines, responsibilities, and validation protocols/reports.
Leads and participates in pilot production and production and provides inputs to drive new product introduction schedules, resolve manufacturability issues, and drive improvements for process yield and efficiency.
Develops and manages pilot build schedules. Leads integration meetings, participates in design reviews.
Provides training to production staffs for assembly, testing, and the use of released equipment, methods and procedures.
Support R&D and manufacturing team in maintaining compliance with medical device quality system requirements, including corrective/preventive action closure, disposition of non-conforming materials, etc.
Perform failure analysis for discrepant production components, assemblies or field returns, and troubleshoot manufacturing line issues.
Lead supplier assessments and line transfers.
Lead continuous improvement projects to improve assembly touch time, production efficiency, and reduce cost.
Other manufacturing engineering duties or support as assigned or requested.
Visit suppliers to lead molding, assembly, line set-up and qualification; support audits, assessments. Travel is to local, domestic and international suppliers.
Required Knowledge/Skills, Education, And Experience
- BS degree in Mechanical, Industrial, Chemical, Biomedical, Materials Engineering or equivalent experience is required.
- Principal: 10+ years’ experience as manufacturing engineer with focus on new product introduction and design transfer. MS degree with 8+ year experience is also considered.
- Strong knowledge of a wide range of manufacturing processes including understanding of key input variables for quality, cost and capacity
- Strong technical skill in materials, process development, plastic injection molding, BOM structure and best practice for flexible instrument or catheter devices and rigid assemblies.
- 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.
- Strong interpersonal skills working with a wide variety of people, skills, backgrounds. Experience with being vendor-facing and supplier management.
- Can do attitude, highly results focused.
- Ability to work alone and collaboratively with others.
- Agile PLM experience is preferred
- Ability to manage multiple priorities in fast-paced environment.
- Ability to manage and execute projects on schedule.
- Ability to travel up to 25%. During critical product design phases, travel may be higher.
- 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)