Job description

Requirements

  • Entry level
  • No Education
  • Salary to negotiate
  • Milpitas

Description

Johnson & Johnson Vision Care, a member of Johnson & Johnson's Family of Companies, is recruiting for a Staff Engineer, New Product Quality to be located in Milpitas, CA.
 
Johnson & Johnson Vision (JJV), is a worldwide company with operations in the United States, Japan, Latin America, Asia-Pacific and Europe/Middle East/Africa regions. Research, innovation and new-product development are the focus of our organization. Since we introduced soft disposable contact lenses in 1988, and through the acquisition of Abbott Medical Optics in 2017, no other manufacturer has matched the aggressive expansion of our wide-ranging Surgical Vision (Cataracts and Lasik portfolio) and Vision Care (ACUVUE and Consumer Eye Health solutions) family of products. Our associates around the world are committed to expanding the J&J Vision brands brand, and fortifying our position as the worldwide leader in total eye healthcare solutions.
 
Caring for the world, one person at a time has inspired and united the people of Johnson & Johnson for over 125 years. We embrace research and science -- bringing innovative ideas, products and services to advance the health and well-being of people. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people every day, throughout the world.
 
•You, the Staff Engineer, New Product Quality will provide Quality Engineering leadership and support in the design of new equipment products used in the refractive and cataract surgeries, as well as, associated accessories. 
•The scope includes equipment development activities situated in Milpitas and also includes supporting design changes throughout the entire product life cycle, including, manufacturing and obsolescence.
•These support activities include research and new product development of software controlled electro-mechanical-laser-optical medical devices and accessories in accordance with design controls, risk management and reliability engineering. 
•Regularly interfaces with members of product development, clinical operations, regulatory, QA and marketing.  
•The individual will also play an important role with respect to the leadership and support of the Equipment Surgical product line.
•The role will provide Quality Engineering support in the design and launch of new products from J&J Albuquerque site.
•The scope includes quality engineering support for instrument/software development activities and includes supporting design changes throughout the entire product life cycle, including, manufacturing and obsolescence.
•Regularly interfaces with members of product development, clinical operations, regulatory, QA and marketing.  
•Ensure design control execution as per procedural requirements. (Phase 0 to product launch). 
•Driver of risk assessment on product. 
•Provide training and guidance on Design Control, Risk Management and Independent review testing activities to site and ensure correct implementation.
•Highlight opportunities for continuous improvement of the Design Control and Risk Management systems to more effectively and efficiently deliver business and quality objectives.
•Ensure defendable science and engineering principles are supported with objective evidence and proper documentation.
•Provide expertise in the practical implementation of Design Control systems to support development and risk management.
•Support CAPA, Auditing and quality system activities as required. System Regulation requirements


Qualifications
•A Bachelor’s Degree is required. A technical degree - Statistics/Engineering/Electronics or other related technical or medical discipline and/ or a Master’s Degree is preferred.
•A minimum of 6 years of relevant work experience is required
•Experience in Medical Device Industry Design Assurance is required.
•A minimum of 3 years of experience in technical medical device product development/ New Product Quality is required.
•Experience in the support of Product Software Development, software quality etc. is preferred.
•Advanced Technical Training in Quality Engineering principles, Risk Management, Product Testing, Ophthalmic Sciences and Technology, Systems Engineering and/or Process Excellence (Certified Six Sigma Black Belt or master Black Belt) is preferred.
•Exposure to reliability engineering and design for reliability is preferred.
•Knowledge on ISO 14971, IEC 60601-1, IEC 62366, IEC

About the company

If you’re thinking about taking your career to a place where you can be seen for the talent you bring to your work, where you’ll have a chance to be the driver of your own career, and where others share your passion for caring and success, then we invite you to explore Johnson & Johnson. BE VITAL in your career and make a unique mark. Join the approximately 129,000 men and women who work within our companies and touch the lives of more than a billion people around the world every day.

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