Staff Engineer Technical Life Cycle Management (US)

Johnson & Johnson•Irvine, CA

19h

About The Position

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through 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 humanity. Learn more at jnj.com As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit. Johnson & Johnson is currently recruiting for a Staff Engineer Technical Life Cycle Management to be based at Irvine , CA, with consideration for Galway, IRE. Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s): (Ireland) - Requisition Number: R-059254 Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission. Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Are you passionate about improving and expanding the possibilities of surgery? Ready to join a team that’s 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 world’s most prevalent conditions such as obesity, cardiovascular disease and cancer. Patients are waiting. Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech JOB SUMMARY The position requires the use of multidisciplinary engineering and supply chain knowledge to assist in the execution of cross-functional projects in support of the company’s strategies, goals, objectives, and product portfolio. Uses knowledge of scientific techniques and process excellence to design, develop and validate safe, effective, and efficient processes. Provides technical support to ensure continuity of supply.

Requirements

A minimum of a Bachelor’s degree is required.
A minimum of 10 years of professional experience.
Familiarity with ISO 13485 Design Control, and manufacturing process IQ, OQ, PQ qualifications as related to medical devices.
Knowledge in some special processes such as polymer processing (compounding, extrusion, fusing), metal processing (machining, laser cutting, polishing), welding, coil winding, equipment & tool design
Strong project management skills required (Microsoft Project, FPX and/or other project management tools).
A highly regulated industry knowledge.
Six Sigma Process Excellence knowledge is required with certification at the Black belt level preferred.
Knowledge of Design for Manufacturability in plastics, metals and small scale assembly process.
Strong communication, team buidling, and cross functional coordination skills.
A Working knowledge of applicable requirements related to the MDSAP jurisdiction.

Nice To Haves

An advanced degree.
Previous supervisory experience.
PMP certification or equivalent
Medical device industry experience.
Process automation knowledge for small scale assembly.

Responsibilities

Execute Life Cycle Management projects in a cross-functional setting.
Work on unusually complex problems and provides solutions which are highly innovative and ingenious.
Apply scientific and engineering knowledge to the development and improvement of medical device products, associated processes, and manufacturing equipment as well as associated validations.
Work independently and in cross-functional teams (both internal and external) to determine root cause, develop mitigations and corrective and preventative actions for processes and manufacturing related issues.
Exercise judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.
Evaluate manufacturing processes / products and collaborates with R&D, NPI, Sourcing, QA, MFG and Finance teams to lead projects / initiatives to improve quality, productivity and reduce costs.
Utilize the application of six sigma and lean tools and methodologies.
Design and develops troubleshooting guides and decision-making matrices to ensure the standard application of methods in the resolution of process/ manufacturing technical issues.
Provide technical training and guidance to manufacturing and engineering personnel.
Ensure quality conduct of projects including design, data summary and interpretation, report and manuscript preparation and review compliance to applicable regulations.
Generate written reports and provide technical expertise to related projects.
Maintain accurate documentation of concepts, designs, drawings, processes, test methods, data analysis and conclusions or rationales.
Provide technical support for outside suppliers, vendors, and/or consultants as required, inclusive of supplier visits and identification / implementation of process improvements.
Provide guidance and work direction to lower-level engineers and related project team members.
Responsible for communicating business related issues or opportunities to next management level.
Responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable.
Responsible for ensuring personal and Company compliance with all International, Federal, State, local and Company regulations, requirements, policies, and procedures.
Performs other duties assigned as needed.

Benefits

Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
This position is eligible to participate in the Company’s long-term incentive program.
Vacation –120 hours per calendar year
Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
Holiday pay, including Floating Holidays –13 days per calendar year
Work, Personal and Family Time - up to 40 hours per calendar year
Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
Caregiver Leave – 80 hours in a 52-week rolling period
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year