Manufacturing Engineering Manager Ekos
THIS JOB HAS EXPIRED MAIN PURPOSE OF JOB
Manage Manufacturing Engineering (ME) team to develop excellence in manufacturing through the
application of engineering fundamentals, applied research, and Design for Manufacturability (DFM)
Prioritize ME goals with Senior Management to achieve corporate strategic objectives. Support
EKOS commercial production lines, establishing a culture of prevention and continuously improving
tools, processes, and facilities.
Support R&D and sustaining engineering projects with DFM expertise, development of production
processes, documentation, and equipment and transfer to manufacturing.
MAIN JOB DUTIES/RESPONSIBILITIES
? Communicate corporate strategy and goals to ME team.
? Plan and execute ME production line support for disposable and durable production lines to
meet forecasted demand and minimize production scrap.
? Lead the ME team in continuous improvements to processes, procedures and equipment to
assure product quality, increase throughput and reduce process variability.
? Assure Tool Qualification, Design Verification, Process Validation, and Product/Process
Performance Qualification activities are performed in compliance with Quality Management
? Work with Operations and provide technical leadership in the development of a Lean
? Work with Supply Chain department to develop suppliers and OEM services, as needed,
including support of supplier qualification.
? Propose and implement changes to EKOS standard operating procedures to optimize
efficiency of ME activities and assure compliance with regulatory and corporate
requirements. Perform associated training.
? Support resolution of internal and external audit findings, including associated Corrective
Action Preventive Action (CAPA) investigation and closure.
? Provide ME resource on R&D project teams to support the development of next generation
devices and new products, including pilot production and transfer to manufacturing.
? Suggest, plan and support implementation of facilities improvements.
? Present progress updates, plans, and proposed budgets to Senior Management. Establish
standard ME metrics, as appropriate.
? Drive communication across organization (EKOS and BTG) to leverage solutions and share
? BS in Engineering (ME, IE, ChemE, or EE) and 10 years of successful experience in
Manufacturing Engineering in a medical device or precision electro-mechanical product
? Minimum 5 years direct supervision experience.
Capable of fluidly scaling between hands-on/ detail oriented support and highly strategic
? Expertise in relevant materials fabrication equipment /techniques.
? Expertise in GMP, ISO 13485, MDD, and QSR requirements.
? Expertise in Lean Manufacturing. Six Sigma expertise preferred.
? Presentation and project management skills and technical writing excellence.
? DFM/DFA, DOE, CAD, SPC expertise. SolidWorks capability.
? Selection of ME direction and priorities
? Signature authority for Document Change Orders (DCOs), protocols and reports, and Non Conformance Reports (NCR) associated with Material Review Board (MRB)
? Development of training plans for ME staff
? Supervision, hiring and discipline of ME staff
? Selection and purchase of equipment, materials and supplies with one-over review
? Selection of facilities systems
||11911 North Creek Parkway South |
Bothell, WA 98011
THIS JOB HAS EXPIRED