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Manufacturing Engineer
Ref No.: 18-16733
Location: Bothell, Washington
Position: Manufacturing Engineer
Location: Bothell, WA 98011
Duration: 12+ months
 
Job Description
  • This position is responsible for developing, validating, and maintaining the production test processes and equipment that support Production and new product introduction.
  • This position is the primary contact for Production, Product Development, and suppliers as related to technical process issues.
 
Reports To: Manufacturing and Test Engineering Manager
 
Principle Responsibilities and Duties:
  • Works within a cross-functional development team on the definition and design of new products.
  • Leads the definition, development, and implementation of Production processes.
  • Works with Product Development and suppliers to define production processes during product development
  • Provides DFM input to Product Development.
  • Participates in supplier and subcontractor selection, qualification and CAPA efforts.
  • Leads the design transfer from engineering to manufacturing.
  • Performs production capacity planning and manufacturing line layout activities.
  • Develops and maintains manufacturing assembly instructions, tooling, and other aids to ensure a controlled and efficient manufacturing process.
  • Develops process and equipment verification and validation plans, reports, etc.
  • Performs process validation activities.
  • Creates and maintains all end item BOM structures and production routes.
  • Performs cost analysis and implements cost reduction plans.
  • Performs data analysis and trending on manufacturing processes.
  • Initiates root-cause analysis and troubleshooting and improvement activities to increase quality and yields, and reduce cost.
 
Experience, Education, Training, Traits:
  • Experience in new process and product development and transfer to manufacturing.
  • Experience in setting up manufacturing lines and processes.
  • Experience in process verification and validation.
  • Experience with the following processes: casting, bonding, plasma etch, mixing, curing, and ultrasonic welding.
  • Demonstrated ability to drive production process improvement through equipment, methods, and design.
  • Experience at utilizing SPC and design of experiments to drive change.
  • Experience utilizing and implementing lean manufacturing concepts.
  • Experience driving DFM improvement into products designs during product development.
  • Working knowledge of medical device FDA QSR s and ISO9001 requirements.
  • Effective communication and documentation skills.
  • A self-motivated and results-oriented individual.
 
Desired skills:
  • BS in engineering or related field.
  • Experience in a medical device capital equipment manufacturing environment.
  • Background in diagnostic or therapeutic ultrasound.
  • Demonstrated ability to coach and train production personnel.
  • Experience with Pro Engineer a plus.
  • Language and Verbal Skills- Ability to read, analyze, and interpret engineering specifications, general business periodicals, professional journals, technical procedures, or governmental regulations.
  • Ability to write reports, specifications, business correspondence, and procedure manuals.
  • Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public.
  • Ability to clearly and concisely convey project accomplishments, obstacles, issues, and status to project team members.
  • Math Skills- Ability to work with mathematical concepts such as probability and statistical inference, and fundamentals of plane and solid geometry and trigonometry.
  • Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.
  • Ability to use MS Excel to perform calculations and interpret project results/data.
  • Analytical and Reading Skills- Ability to define problems, collect data, establish facts