The Sr. Manufacturing Engineer - NPI will drive the design transfer of a new product into the Instruments Manufacturing team. The Sr. ME at this level of experience is expected to show good judgment, with little supervision involved, in leading change, contributing new ideas, and finding innovative methods to accomplish goals, and have the ability to get things done through people that do not report to them. The added New Product Introduction (NPI) responsibility to the Sr. ME role requires collaborating with the engineering design team to develop a new product with DFX (Design for Excellence) in mind, followed by transferring such design to downstream operations including Production, Supply Chain, Service, Master Data, Documentation Systems and the customer.
- Supports the introduction of new products into manufacturing as a member of a NPI program team representing Operations. Engages in prototypes and pilots in order to establish processes and assembly documentation. Reviews engineering designs and documentation for completeness, clarity and manufacturability. Evaluates and qualifies new suppliers. Trains production personnel.
- Leads an extended team of Production, Supply Chain, Service, Document Control, Quality, Material Handling, Logistics, and Supplier representatives in transferring designs to manufacturing
- Supports sustaining engineering activities as a key member of, and sometimes leads, cross-functional project teams in Operations. After NPI launch, the manufacturing engineer’s follow-on objectives include: improving manufacturing operational efficiency, optimizing product design, qualifying replacement components or suppliers, improving product quality, improving customer satisfaction, maintaining a lean manufacturing environment, or reducing manufacturing costs.
- Provides manufacturing process requirements and best practices to other project teams in ensuring Production readiness.
- Provides hands-on support to the manufacturing assembly and test processes for flow cytometry instruments. Must be an adept and experienced problem solver who is able to determine root cause of difficult technical issues. Must be able to implement effective solutions in a timely manner. Issues are typically multi-disciplinary in nature: mechanical, optical, electrical, and fluidic.
- May engage in internal and field failure investigations, identifying root cause, and participating in corrective and preventative action efforts.
- Keeps abreast of the basic requirements for EMC, safety and environmental compliance in own area of work and complies with those requirements. Participates as required in training on regulatory issues affecting own area of work. Brings regulatory compliance questions/issues to the attention of management.
- Understands product structures, manufacturing models, engineering drawings, Bills of Materials, operational procedures, shop-floor and material movement controls and routings
- Authors and manages Engineering Change Orders from initiation to implementation.
- Requires a BS degree: ME, EE, IE, IT or equivalent
- 4-6+ years’ experience in a high-tech medical device manufacturing environment
- Excellent written and verbal communication and interpersonal skills: conflict resolution, negotiation, and time management skills
- Must be able to understand engineering drawings, Bills of Materials, and operational procedures
- Experience developing manufacturing processes, writing procedures, and training assembly personnel, working with quality and reliability teams to conduct risk analyses, FMEA reviews and able to define critical-to-quality criteria and present IQ/OQ/PQ test plans for proposed changes or solutions.
- Willingness to travel to suppliers up to 10%
- Proficiency with some of the following applications: SolidWorks, Creo/Pro-E, AutoCAD, MS Project, MS Access, SAP ERP, Minitab
- Experience resolving technical issues involving lasers, optical components, fluidic systems or digital/analog circuitry.
- Experience supporting some of the following commodities or supplier types: lasers, optical components, fluidic systems, machined parts, sheet metal, cables, PCA’s, plastics, power systems, product packaging, turnkey subcontractors, hardware, labeling
- cGMP familiarity 21 CFR part 820, medical device manufacturing experience
- Experience implementing Demand Flow Technology (DFT) processes
- Experience implementing LEAN manufacturing processes
- 6 Sigma green or black belt
Base Salary - $130,000 to $140,000
Bonus Eligible - Yes
Seniority Level - Mid-Senior
Minimum Education - Bachelor's Degree
Willingness to Travel - Occasionally