The Sr. Manufacturing Engineer plans and oversees the execution of manufacturing process development for NPD, engineering change requests, product sustaining, and continuous improvement. S/he will collaborate with contract manufacturers (CMs) and upstream suppliers, as well as company's cross-functional teams to design, develop, and drive improvements to product DFM, manufacturing system, quality, reliability, cost and output. Roles and Responsibilities:
Perform as a bridge between internal product development team and external suppliers to communicate technical matters.
Design, document, assemble, qualify and introduces production assembly/test/inspection fixtures and equipment.
Proficient in reading and creating mechanical drawings.
Takes ownership of products during product transfer phase through successful and sustained project launch. This includes driving schedules, resolving manufacturability issues, and driving improvements for cost and efficiency.
Provides product and process DFM (Design for Manufacturing) input to Product Development Engineering to enhance manufacturability and product cost.
Creates an efficient manufacturing assembly line, specifying and/or refining BOMs, work flow processes and detailed work instructions.
Modifies BOM's, work instructions, and process flow diagrams by ECO writing and implementation as requested by R & D or NPD.
Designs and creates production equipment, fixtures and tests as needed to build the production line either internally or at suppliers.
Provides training and support to production technicians.
Responsible for maintaining compliance with medical device quality system requirements including corrective/preventive action closure, discrepant material dispositions.
Provides technical support analyzing and/or performing failure analysis for discrepant production components, assemblies and field returns.
Leads/participates in continuous improvement initiatives focused on material cost reduction and capacity enhancement.
Must possess strong communication skills to interface with technicians, product development, planning, purchasing, regulatory, inspection, clinical marketing organizations, and suppliers.
Building the manufacturing line could either be internal or external at a supplier.
Supports, maintains, improves modifies and further develops the manufacturing line as needed for sustaining production.
Other reasonable assigned duties.
4-year degree in Mechanical or Industrial Engineering.
5+ years of experience as manufacturing engineer supporting product with medical device content.
Demonstrated understanding of manufacturing processes including precision mechanical assembly, testing, troubleshooting and rework.
Demonstrated knowledge of inspection processes and Lean principles.
New product development experience.
CAD experience (Solid Works preferred).
Strong problem-solving ability, including demonstrated ability to effectively design, execute, report on, and draw conclusions from experiments.
Excellent communication, organization, follow-up and documentation skills.
Comfortable interacting with technicians, engineers, and management all on a regular basis.
Strong technical skills in prototyping, tooling development and troubleshooting.
Experience in medical device manufacturing environment.
Able to work in both US and China with up to 50% travel