Manager Technical Lifecycle Management

Johnson & Johnson is recruiting for a Manager, Technical Lifecycle Management to join our team in Irvine, CA.

About MedTech

Fueled by innovation at the intersection of biology and technology, we’re 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 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 support changes required. Provides technical support to ensure continuity of supply while managing an engineering team.    

DUTIES & RESPONSIBILITIES   

Under general supervision and in accordance with all applicable international, federal, state and local laws/regulations/requirements and Corporate Johnson & Johnson, procedures and guidelines, this position:    

• Drive the execution of Life Cycle Management projects in a cross-functional setting.   

• Work under consultative direction toward predetermined long-range goals.    

• Work on unusually complex problems and provides solutions which are highly innovative and ingenious.    

• Apply broad scientific and engineering knowledge to the development and improvement of medical device products, associated processes, and manufacturing equipment as well as associated validations.      

• Work with 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.   

• Demonstrates leadership abilities within and across functions.   

• Demonstrates people skills to lead engineering team  

• Evaluate manufacturing processes / products and collaborate 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 engineering personnel.  

• Ensure the quality of projects including design, data summary and interpretation, report and manuscript preparation and review compliance to applicable regulations.  

• Evaluate progress and results against goals and objectives.  Recommends major changes in procedures or objectives.  

• 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.  

• Work out proposals and cost estimates of project/process related costs or cost improvements.  

• Provide guidance and work direction to direct reports 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.  

EXPERIENCE AND EDUCATION    

• A minimum of Bachelor’s degree in Engineering is required.    

• An advanced degree in preferred.    

• A minimum of 10 years of professional experience is required.   

• A highly regulated industry knowledge is required; Medical device industry experience is preferred.    

• Previous supervisory experience is required.    

• Familiarity with ISO 13485 Design Control, and manufacturing process IQ, OQ, PQ qualifications as related to medical devices is required.   

• Six Sigma Process Excellence knowledge and Black Belt Certification is preferred   

• Knowledge of financial accounting and analysis methods to assess product standard costs, project values, and capital requirements is required.    

• Leadership experience in managing technical relationships with external suppliers and OEMs is required.     

REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/LICENSES and AFFILIATIONS.   

•  Strong project management skills required (Microsoft Project, FPX and/or other project management tools).   

 •  Supplier development skills.   

 •  Strong communication, team building, and cross-functional coordination skills.