Senior Manufacturing Development Engineer

Johnson & Johnson Innovative Medicine • Cincinnati, OH

17h • $92,000 - $148,350 • Onsite

About The Position

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.

Requirements

• Minimum of a Bachelor’s Degree is required, preferably in Engineering.
• Minimum of 4 years of manufacturing / development experience required
• 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
• 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
• PLM system navigation (ie. Windchill)
• Navigation within EES based data visualization and reporting (ie. Tableau, Power-BI, etc.)
• 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]

Nice To Haves

• Master’s Degree or MBA Preferred
• Process Excellence methodologies – Belt certification preferred
• Preferable proficiency in manufacturing simulation and analysis software
• Preferable proficiency in CAD software

Responsibilities

• 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
• 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.
• Performs other duties assigned as needed

Benefits

• 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
• 10 days Volunteer Leave – 32 hours per calendar year
• Military Spouse Time-Off – 80 hours per calendar year

What This Job Offers

• Job Type: Full-time
• Career Level: Senior