NPI Manufacturing Engineering Manager

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are our expertise in Innovative Medicine and MedTech we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for more at

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Johnson & Johnsons Family of Companies is recruiting for a NPI Manufacturing Engineering Manager MONARCH within our Robotics & Digital Solutions (RAD) organization. This role is based in San Jose California.

At Johnson & Johnson MedTech we are working to solve the worlds most pressing healthcare challenges through innovations at the intersection of biology and technology. We harness our deep expertise in surgery orthopedics vision and interventional solutions to design healthcare solutions that are smarter less invasive and more personalized. The MedTech Surgery organization was recently established to combine our market-leading surgical portfolio with the Robotics & Digital portfolio.

Are you passionate about improving and expanding the possibilities of surgery Ready to join a team thats reimagining how we heal Our Surgery team will give you the chance to deliver surgical technologies and solutions to surgeons and healthcare professionals around the world. Your contributions will help effectively treat some of the worlds most prevalent conditions such as obesity cardiovascular disease and cancer. Patients are waiting.

MONARCH is looking for a motivated Manager to lead the NPI Manufacturing Engineering team in New Product Introduction (NPI) initiatives. Responsibilities include coordinating activities across manufacturing to ensure timely product launches. The role of Manufacturing NPI Engineering Manager will support the Instruments & Accessories (I&A) for the Monarch business unit.

Duties & Responsibilities

• Provides day-to-day tactical engineering direction and guidance for engineering associates supporting manufacturing to ensure short and long-term goals are met.
• Primary lead contact for other functions such as Operations PP&L (Packaging Processing & Labeling) QA R&D PM NPI as needed to achieve company goals and objectives.
• Provides training guidance coaching performance appraisals mentoring and career development for engineers.
• Owns the successful implementation of new technology processes and systems as well as continuous improvement to existing processes & technology.
• Medical device experience with Class II or equivalent experience in capital & I&A development is required.
• Demonstrate Credo based leadership.
• Grow the NPI (New Product Introduction) teams capabilities both by developing existing talent and hiring new talent as we continue to grow.
• Build strong teams through trust and mentorship.
• Develop NPI in the business and partner closely with leaders in other engineering teams design and product management to champion a shared advanced manufacturing vision.
• Craft data-driven strategies and action plans to deliver improvements to our manufacturing process.
• Ensure the work produced by the team follows industry-standard research methodologies and processes.
• Identifies designs and develops equipment related to new product development.
• Responsible for preparing and delivering process and test specifications.
• Responsible for purchasing and designing equipment that meets J&J standards of safety and environment requirements.
• Responsible for developing new manufacturing and assembly processes consistent with Design for Manufacturability and Assembly for new product introductions in accordance with regulatory industry and J&J standards.
• Continuously seeks automation opportunities to reduce costs and improve quality.
• Coordinates and performs qualification of new and improved manufacturing equipment and automation systems.
• Coordinate and technically support the work of engineers and technicians.
• Responsible for communicating business-related issues or opportunities to the next management level.
• Provides problem-solving and technical assistance to manufacturing engineers and operations to resolve process control issues.
• Partner multi-functionally to meet business objectives including quality financial EH&S and performance goals.
• Evaluates new technologies to improve process safety quality reliability and efficiency. Implements digital solutions to solve problems and enhance process performance.
• Coordinates training of personnel on equipment operation and maintenance.
• Submits Capital Appropriation Requests (CAR) for project funding and manages both capital and operational expense budgets.
• Plans & implements with the support of a team I&A manufacturing lines through development procurement fabrication and qualification (inclusive of lean line layout capacity planning material procurement build schedule management etc.).
• Responsible for ensuring personal and Company compliance with all Federal State local and Company regulations policies and procedures as it relates to medical devices.
• Adheres to J&J environmental and safety policies and guidelines.
• Accountable to the Johnson and Johnson Standards of Leadership (Credo Values customer/Marketplace Focus Innovation Interpersonal and People Development).

Qualifications

• A Bachelors degree in Engineering or related is required; Mechanical Biomedical or Mechatronics is preferred.
• Minimum of 8 years of relevant professional experience is required.
• Minimum of 2 years of work experience as a people leader developing direct reports is required.
• Manufacturing engineer background with experience in end to end equipment development in order to provide guidance and mentorship.
• Advanced skill level in process validation and test method validation preferred.
• Track record of influencing both strategic and tactical product decisions with insights derived from characterization studies is required.
• Experience improving manufacturing processes with process data and engineering studies is required.
• Effective organizational skills to advance research activities across multiple teams and projects is required.
• Knowledge of good manufacturing practices and documentation for production processes is required.
• Statistical Process Control (SPC) knowledge and management of statistical procedures is required.
• Excellent knowledge in Quality system QSIT and FDA guidelines 21CFR 820 21 CFR Parts 210 and 211 ISO 13485 ISO 14971 and relevant guidance preferred.
• Excellent verbal and written communication.
• Knowledge of Microsoft Office SAP Jira Teams and Minitab is require.
• Comprehension of standard costs and work standards management in SAP (ERP Systems) is required.
• Comprehension of engineering design documentation and drawing specification understanding as it relates to process controls; specific at the component and fixture level for identifying key drawing features to support DFM/A is required.
• Strong problem-solving skills.
• Experience in medical device manufacturing is required.
• Experience with Design of Experiments (DOE) preferred.
• Green Belt certification is required Black Belt certification is preferred.
• Ability and willingness to be based in San Jose CA and travel 10-20% domestic and international.

The anticipated base pay range for this position is 114000 - 197225 California Bay Area

Fueled by innovation at the intersection of health and technology were developing the next generation of smarter less invasive more personalized treatments. Your unique talents will help patients on their journey to wellness. Learn more at Johnson & Johnson were on a mission to change the trajectory of health for humanity. That starts by creating the worlds healthiest workforce. Through innovative programs and policies we empower the physical mental emotional and financial health of our employees and the ones they love! At Johnson & Johnson we offer a variety of outstanding health and financial benefits including competitive compensation 401k pension medical dental and vision insurance exercise reimbursement flexible time off paid volunteer and parental leave and more! For more information on how we support the whole health of our employees throughout their wellness career and life journey please visit.

Johnson & Johnson is an 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 disability protected veteran status or other characteristics protected by federal state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants needs. If you are an individual with a disability and would like to request an accommodationexternal applicants please contact us via internal employees contact AskGS to be directed to your accommodation resource.

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