Staff Manufacturing Engineer, NPI - United States
Using Lean principles, develops the cellular manufacturing and facility layouts for a new electro-mechanical medical device currently being developed. Establishes the material flow across the facility from receiving through finished goods storage and develops the standard work for the assembly, test and packaging cells. Identifies opportunities to mistake-proof the new product design as well as the manufacturing, assembly and test processes. Supports manufacturing and supply chain leaders in developing short and long-term capacity planning as well estimate the footprint and labor required to receive, inspect, assemble, test, package, and store devices.
PRINCIPAL RESPONSIBILITIES AND DUTIES:
Develops manufacturing cell concepts and performs detailed layouts using Lean principles to assemble, test and package a new electro-mechanical medical device during the product development, validation, launch and full-rate production stages Determines manufacturing footprint and labor needs for the new product based on the demand requirements for each of the stages of the new product development and introduction process Establishes standard work across facility and within manufacturing cells to balance the lines; develops detailed work instructions for each work station Coordinates with Supply Chain and other functions to establish material flow across the manufacturing facility from receiving through finished goods storage Works with Suppliers and Supply Chain to establish parts presentation approaches to efficiently deliver components the manufacturing cells Assists Supply Chain and Manufacturing leaders with developing short and long-term capacity plans for manufacturing facility based on demand estimates Identifies and implements assembly aids to mistake-proof assembly, test and packaging operations Coordinates with other functions to ensure information flows are accurate and efficient to and from manufacturing operations Other duties as assigned
Scope of Responsibilities:
Experience designing, developing and implementing Lean manufacturing operations for regulated, electro-mechanical medical devices in a cGMP environment Experience deploying Lean manufacturing techniques in the early stage product development cycle and scaling volumes through full-rate production Incumbent executes responsibilities with a large degree of autonomy requiring minimal oversight by immediate supervisor Incumbent must engage and gain the support of associates in various positions of responsibility and in various functions within MMS Operations, Supply Chain, Quality, R&D and Sourcing. This includes associates in these functions who occupy positions of authority that is equal to, greater than or less than the incumbent. Incumbent must clearly communicate project plans and resource requirements to gain the support of these individuals Incumbent deals with a wide variety of manufacturing, supply chain and transactional processes including assembly, test and inspection methods, packaging, receiving inspection, spare parts management, change control, and sustaining engineering of which any combination must meet the requirements of regulated medical device manufacturing
Impact of Results: Develops facility and manufacturing layouts and determines footprint and labor requirements for the verification, scale-up and full-rate production environments Establishes standard work and work instructions for the manufacturing operations Builds MMS Lean manufacturing capability and processes to introduce, qualify, launch and scale new products
- Bachelor's Degree in Mechanical, Electrical, Industrial Engineering or other technical equivalent may be considered, however, a combination of 8+ years of work experience and/or education will be taken into consideration.
- Strong Lean Six Sigma knowledge (Lean Leader, Green Belt, Black Belt)
- Experience establishing cellular manufacturing and flow for electro-mechanical assembly and test operations
- Facilitation & Change management leadership skills/experience.
- Excellent planning, organization, analysis, and problem solving skills.
- Excellent written and oral communication skills.
- Proven track record of delivering tangible results
- FDA/Medical device experience preferred
- Ability to travel up to 25%
Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status