Staff Component Engineer
- Redwood City, CA
The Auris Robotics & Digital Solutions (RAD) group, part of the Johnson and Johnson family of companies is recruiting for a Staff Component Engineer, located in Redwood City, CA
Auris is a technology company defining the future of 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.
As a Staff Manufacturing Engineer, the individual will participate in product development core team as a manufacturing engineering lead. This position will be responsible to provide internal and external (vendor) design for manufacturing (DFM) input to product design to enhance manufacturability and reduce cost. The individual will work with supply chain to guide the development team in choosing suppliers, determine make vs. buy strategy, and support supplier process development effort. Drive suppliers to continuously improve business and manufacturing processes.
Core Job Responsibilities:
- Select and evaluate suppliers by leading efforts to find new suppliers in an existing or new commodity and works with Engineering to maximize use of the production supply base.
- Works with supply chain, engineering, and supplier for the new product introduction to
- Create supplier landscapes to determine launch readiness
- Develop supplier ramp readiness plans by judging business risk based on forecast, supplier capacity, quality performance, and process capability.
- DFM by engaging suppliers early in development cycle to feedback manufacturability improvements in the designs prior to production
- Guide Engineering in choosing suppliers by determining selection criteria for preferred suppliers and leading the team effort to evaluate preferred suppliers.
- Deliver the following Quality deliverables: pFMEA, Process Validations, FAI, and Cpk by leading suppliers through the pFMEA development, determining process validation requirements, evaluating process capability with supplier as well as judging FAI suitability.
- Leads/participates in continuous improvement initiatives focused on material cost reduction, capacity/efficiency improvement, and streamlining of supply chain.
- Design and develop production equipment, fixtures and tests as needed to build the production line internally or as needed at suppliers.
- Ensure compliance to quality management system and regulatory requirements by leading and mentoring auditors for QMS audits
- Manage detailed projects of design transfers internally and/or externally by leading efforts with little guidance/mentoring from management.
- Drive suppliers to continually improve their business and manufacturing process performance to meet business requirements for supplier excellence using a collection of best practices in project management, Six Sigma, Lean, SPC and negotiation by leading these efforts without managerial guidance at several suppliers simultaneously.
- Support corrective actions for supplier process by driving suppliers to true root cause analysis and corrective and Preventive actions.
- Driving change to specifications as necessary by understanding and changing specifications and drawings including driving the ECO process to implementation.
- Identify and investigate opportunities for cost reduction and/or quality improvement by evaluating opportunities and creating strategies and provides data-driven plans to management.
Required Knowledge/Skills, Education, And Experience
- BS degree in Engineering or equivalent required, Master's degree preferred
- Minimum 10 years related experience in manufacturing engineering with focus on Supplier Quality and/or Supplier Development or related field
- Demonstrable knowledge of a wide range of manufacturing processes including understanding of key input variables for quality, cost and capacity (specialization can be in metal fabrication, plastics, electronics, and/or contract manufacturing)
- Demonstrated knowledge of mechanical assembly, testing, and inspection processes and Lean principles.
- A proven history of implementing Lean/6 Sigma/SPC Programs at suppliers is a plus
- Excellent Project Management skills
- Excellent analytical skills along with good judgment
- Demonstrable knowledge in evaluating and challenging supplier technical, quality, and business capabilities
- Excellent knowledge of 21 CFR part 820 and ISO 13485
- Significant computer experience using Windows, Word, Excel, Access and ERP Information Systems, preferably SAP
- Ability to read and interpret detailed mechanical drawings and communicate technical information. CAD experience with 3D modeling tools is a plus
- Proven ability to motivate suppliers
- Experience in a high-volume medical device company is a plus
- Ability to travel up to 10% of the time to suppliers on an as needed basis - domestic and international
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.
United States-California-Redwood City-150 Shoreline Dr
Auris Health, Inc. (6267)
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