Auris Health Inc., part of the Johnson & Johnson family of companies, is recruiting for a Senior Manufacturing Engineer- Capital Equipment NPI, 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/.
Auris is seeking for a Sr NPI Manufacturing Engineer to work with and across all functional areas of the company to enhance customer experience by improving product quality and usability. The right candidate will contribute his/her technical manufacturing and project management skills to a dynamic development team creating surgery assisted robotic systems and New Product Innovation team. The role requires active participation in process development and refine electro-mechanical components, assemblies, process documentation, tooling and test methods while challenging new product designs to improve efficacy, reliability, manufacturability and cost for robotic components and subassemblies.
The right candidate will be an empowered self-starter familiar with working in a fast pace environment.
Core Job Responsibilities:
- Actively participate with the engineering team, providing manufacturing leadership throughout the product development process
- Develop, maintain and improve "mid-volume" manufacturing assembly line, specifying and/or refining BOMs, workflow processes, and detailed work instructions.
- Work with outside suppliers to specify, document, procure, qualify, implement, and improve fixtures, hand tools and equipment.
- Support product launch with labor estimation, equipment needs and packaging requirements
- Determine, incorporate and validate critical tests used in manufacturing.
- Validate manufacturing processes and providing production support through successful and sustained project launch.
- Identify and implement continuous improvement projects with respect to first pass yield, cycle time reduction, product reliability, capacity enhancement and cost reduction.
- Takes responsibility for maintaining compliance with ISO13485 quality system including corrective action closure, discrepant material dispositions and ECO implementation.
- Responsible for PFMEA, risk mitigation and corrective actions.
- Provides technical support analyzing and /or performing failure analysis for discrepant production components, assemblies and field returns.
- Work collaboratively with the Support and other cross functional Organizations for product and process improvements.
- Work with the Manufacturing floor on solving any technical issues
- Work with the Manufacturing floor on CIP projects.
- Bachelor’s degree in Manufacturing, Mechanical, Electrical or Industrial Engineering or related field is required
- Medical device experience preferred but not required.
- A minimum of 3 years’ experience as process design or manufacturing engineer supporting product with significant mechanical / electro-mechanical products is required
- A minimum 1 years CAD experience with SolildWorks or related application for tooling for mechanical assembly and fixture design.
- Ability to work in a regulated environment in compliance to ISO 13485 and 21 CFR 820.
- Must possess strong communication skills to interface with technicians, product development, planning, purchasing, compliance, quality, inspection, customer support and marketing teams.
- Ability to train and develop work instructions is required
- Prior responsibility for process, manufacturing tool design, equipment or product validation/verification.
- Prior experience designing automated equipment, complex mechanism manufacturing is a plus
- New product introduction/development is required with Robotics knowledge a plus.
- Manufacturing Assembly line and layout design as required
- In depth knowledge of purchasing processes
- Experience in a high-volume ECO environment
- MS Office skills (MS Outlook, PowerPoint, Excel)
- ‘Can do’ attitude to work within cross-functional teams
- Strong problem-solving abilities and capable of articulating specific technical topics or assignments.
- Identifies opportunities for innovation and offers new ideas.
- Experience in JIT, Demand Flow Technology, or Lean Manufacturing techniques.
- Project Management experience
- Ability to meet a 10% travel requirement, international and domestic
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-
Auris Health, Inc. (6267)