Principal Engineer, New Product Quality


Johnson & Johnson Vision Care, a member of Johnson & Johnson's Family of Companies, is recruiting for a Principal 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 Principal 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.

You the Principal Engineer, New Product Quality will:

  • Define complex issues; recommend and guide implementation of system strategies; manage projects day-to-day operations within area of responsibility.
  • Be a technical expert for functional area; make the complex clear and compelling; conceptual knowledge of all responsible functions and business areas.
  • Represent the function in providing solutions to difficult technical issues. Communicate compliance policy and critical decisions to all levels of management.
  • Help creates innovative and simple design quality and reliability engineering systems by working closely with the Site Quality Management, R&D, Complaint Handling, Data Analytics, Product Safety, Clinical/Medical Affairs, Field Services, Clinical Education and Medical Safety Officer.
  • Mentor and facilitate successful team behavior within and across functional area and typically serves in a technical leadership role. Manage relationships externally and internally by influencing and persuading teams to bring about process, regulatory compliance and technical improvements. Build cross-functional and cross-departmental support.
  • 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, Risk Management and Independent review testing activities throughout the NPQE team, as well as, with key partners.
  • Plan and provide support for FDA and other governmental or ISO Notified Body inspections conducted at JJVS locations, including pre- and post-inspection support, as requested. Serve as company representative on Design Controls, Risk Management and Human Factors during regulatory inspections. Support activities may include actively and directly interacting with inspectors/auditors, obtaining required information, and assisting with corrective action and/or remediation plans, as necessary.
  • Perform other related duties as assigned by management.
  • Learn surgical procedures and map the product solutions into potential areas of risk and liability.
  • Challenge science and engineering principles from top level researchers, clinicians and medical affairs.
  • 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
  • May have some direct managerial responsibilities for the department.



Qualifications
Requirements
  • A Bachelor’s Degree and a minimum of 8 years of relevant work experience is required
  • Experience in Statistics/Process Engineering/Medical Device Industry is preferred.
  • A technical degree - Statistics/Engineering/Electronics or other related technical or medical discipline and/ or a Master’s Degree or PhD is preferred.
  • A minimum of 4 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.
  • Capital equipment experience 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 required.
  • Knowledge on ISO 14971, IEC 60601-1, IEC 62366, IEC 62304 and other specific product standards is preferred.
  • Strong leadership, coaching and teaching skills are required.
  • Demonstrated influencing skills and management abilities without people reporting is required.
  • Experience as an expert consultant and advisor to management and excellent communication, interpersonal and organizational skills are required.
  • Experience with Microsoft Office products, in particular Microsoft Project is required.
  • This position will be located in Milpitas, CA and may require up to 10% domestic 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.



Primary Location
United States-California-Milpitas
Organization
AMO Manufacturing USA, LLC (6240)
Job Function
Quality Assurance
Requisition ID
8692180802