Senior Manufacturing Development Engineer

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.

Job Function: R&D Product Development Job Sub Function: Biomedical Engineering Job Category: Scientific/Technology All Job Posting Locations: Cincinnati, Ohio, United States of America Job Description: Johnson & Johnson is recruiting for a Senior Manufacturing Development Engineer to be located in Cincinnati, OH. 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: This job description covers job responsibilities and skills for the LCM, Life Cycle Management, Development Engineer position within the GTO, Global Technical Operations organization.

LCM Development Engineers are responsible for: Leading and executing change control activities associated with active products across the portfolio Functioning as an integral member of the Product Focus Teams within Life Cycle Engineering in support of manufacturing operations performed by both Internal and External Manufactures and Suppliers Duties & Responsibilities: In accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position: Policies : Know and follow Ethicon policies and procedures related to work activities performed in area of responsibility Training : Complete training in areas of responsibility within allowed time. Training is required for changes to existing policies and procedures, for new assignments and for implementation of new policies and procedures.

Complete required periodic re-training in areas such as safety and environmental. Safety : Follow all company safety policies and other safety precautions within work areas.

Promote safety to all associates that enter work area. Assistant through Primary: Coordinate and execute all activities pertaining to development engineering responsibilities for given projects or initiatives Create and perform engineering studies & analyses on existing manufacturing processes to improve process reliability, problem solve, or to improve product quality & cost Key liaison between design team, quality, supply chain, planning, internal and external sites and suppliers to maintain the life cycle of the products in the marketplace meeting quality, cost, and capacity goals Structure and execute change control activities supporting products in the Life cycle portfolio in accordance with the following processes including but not limited to: CP0150, CP0235, CP000636, WE001510, and 501442889 Assess and communicate project updates, resource needs, opportunities and risks to management or partner organizations Adhere to EES Quality System Requirements and Legal Hold Notices Develop strategy for validation of components and devices across assembly, packaging, and sterilization.

Provide performance feedback for/to other team members. Participate in customer interface events as needed Consultant to New Product Development engineering for design, manufacturing, and quality issues Key responsibilities of Senior level in addition to all above responsibilities: Apply comprehensive & diverse knowledge of engineering / business principles to a broad range of assignments Plan, conduct, communicate & direct engineering / business projects to completion with minor support and oversight Coordinate & direct activities of other technical support staff & delegate their assignments as required Collaborate with multiple functions in order to structure project execution plans identifying DRI’s and partners Execute phase in and phase out of components on a finished good device Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures Responsible for following all Company guidelines related to Health, Safety and Environmental practices as applicable.

For those who supervise or manage a staff, 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 Performs other duties assigned as needed EXPERIENCE AND EDUCATION* Minimum of a Bachelor’s Degree is required, preferably in Engineering. Master’s Degree or MBA Preferred Minimum of 4 years of manufacturing / development experience required REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/LICENSES and AFFILIATIONS * General knowledge / awareness of: Surgical procedures and human anatomy Ethicon documentation systems CFR820, GMP (Good Manufacturing Practices), knowledge of operating in a regulated industry, ISO 9000 (International Organization for Standardization), and EUMDR (European Union Medical Device Regulation) Standard manufacturing performance metrics such as: Manufacturing cycle time, Yield, Throughput, Capacity Utilization, Overall Equipment Effectiveness (OEE), WIP inventory / turns, Cost of Goods (COGS); Lead time Process Excellence methodologies Design Excellence methodologies Process Excellence methodologies – Belt certification preferred Analytical problem solving Applied Statistics related to process controls, capability studies, and process validation Effective oral, written and presentation communications Self-managed; work with minimal supervision Technical writing: protocols, test results, procedures, and special reports Project and Portfolio Management tool utilization and application Risk Analysis and contingency planning Resource management of projects Engineering drawing interpretation including GD&T (Geometric Dimensioning and Tolerancing) Rapid Prototyping Component / assembly inspection technologies Component manufacturing technologies Knowledge of materials manufacturing (metals, plastics, chemical, etc.) Device assembly technologies and processes Negotiating skills Global mindset; able to understand all inputs/risks and outputs/benefits involving project and business DOE (Design of Experiments) DFMA (Design for Manufacturing, Assembly and Cost) Validation processes consisting of but not limited to: IQ, OQ, PQ, TMV’s and Software Validations Change Control procedures including but not limited to: CP0150, CP0235, CP000636, WE001510, and 501442889 E2E supply chain knowledge consisting of but not limited to: inventory management, demand planning, Phase in/Phase out, back order Computer skills Windows based personal computer software including word processing, spreadsheet, e-mail, project planning and presentations Preferable proficiency in manufacturing simulation and analysis software Preferable proficiency in CAD software PLM system navigation (ie.

Windchill) Navigation within EES based data visualization and reporting (ie. Tableau, Power-BI, etc.) Leadership Skills Ability to demonstrate and inspire the behaviors that reinforce Our Credo [CREDO] Ability to develop deep insights into the needs of our patients, customers, markets and communities [CONNECT] Ability to drive innovation; anticipate and shape industry and market changes to advance health care globally [SHAPE] Ability to create an environment where leadership and talent development is top priority [LEAD] Ability to develop one’s self and motivate others to become their best [GROW] Johnson & Johnson