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Staff Quality Engineer, NPD
Requisition ID: 6575171211
Johnson & Johnson Vision Care, a member of Johnson & Johnson's Family of Companies, is recruiting for a Staff Quality Engineer, NPI 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 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 Quality Engineer, NPI 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, and advanced engineering.
You, the Staff Quality Engineer, NPI will:
- Define complex issues; manages projects day-to-day operations within area of responsibility.
- Be a technical expert for functional area; makes the complex clear and compelling; conceptual knowledge of all responsible functions and business areas.
- Represent the function in providing solutions to difficult technical issues.
- Help creates innovative and simple design quality and reliability engineering systems by working closely with the project teams.
- Mentor and facilitate successful team behavior within and across functional area and typically serves in a technical leadership role on the team especially in the area of Design Control and Risk Management.
- Be a key advocate for continuous improvement of the Design Control and Risk Management systems to more effectively and efficiently deliver business and quality objectives.
- Provide consulting, training and guidance on Design Control and Risk Management activities throughout the NPQE team, as well as, with key partners.
- Plan and provides support for FDA and other governmental or ISO Notified Body inspections conducted at JJVS locations, including pre- and post-inspection support, as requested.
- Perform other related duties as assigned by management.
- Quickly learn surgical procedures and map the product solutions into potential areas of risk and liability.
- Support on-market design changes.
- Provide leadership and expertise in the practical implementation of Design Control systems to support the development and risk management of refractive and cataract equipment, with focus on effectively and efficiently delivering the Target Product Profile (TPP) and complying with the appropriate Quality System Regulation requirements.
- A Bachelor’s Degree in Statistics/Engineering/Electronics or other related technical or medical discipline and a minimum of 6 years related experience is required.
- A Master’s Degree or PhD is preferred.
- Advanced Technical Training in Quality Engineering principles, Risk Management, 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.
- Software development support is required
- Experience in ISO 14971 is required
- A minimum of 4 years technical medical device product development experience is required.
- Capital equipment experience is preferred.
- Excellent communication, interpersonal and organizational skills are required.
- This position will be located in Milpitas, CA and may require up to 20% domestic and/or international travel.
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.
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