Staff Electrical Engineer, Product Lifecycle

Salary depends on experience
Posted on 06/21/18
San Diego, CA
5 - 7 years experience
Accounting, Finance & Insurance
Salary depends on experience
Posted on 06/21/18

The Electrical Engineer NPI Engineer will work closely with development teams on developing new precision and high-performance Bio-Medical embedded system products for both Research Use Only and FDA-regulated markets. Main responsibility is to ensure successful introduction of newly developed products into routine volume production in a factory manufacturing environment.

Responsibilities:

  • Experience with emphasis on equipment and process development applicable to plastics manufacturing
  • With process development, quality and supply chain departments, lead technology transfer and final stages of process development
  • Contribute to the selection of contract manufacturers from technical perspective
  • Serve as voice of operations on development programs with a focus on sustainable product design that meet customer requirements
  • Ensure the development of technical competencies in the production staff to support manufacturing processes at contract manufacturers
  • Utilize software tools to accomplish goals and manage projects; demonstrate technical ownership of projects or products
  • Lead or participate in process improvement initiatives. (Six sigma, Kaizen, Lean, FMEA, etc)
  • Working knowledge of quality system as applied to new product development and manufacturing including: SPC, design of experiments and statistical analysis
  • Experience in contributing to manufacturing development programs with internal engineering groups and external technology development partners
  • Motivated, self-starter with strong data driven, process orientated approach to area of focus
  • Excellent written, oral communication and cross functional collaboration skills to make sound engineering decisions based available data and experience
  • Prior pilot operation & process development experience desirable with focus on plastics assembly, injection molding, blow molding
  • Experience in developing test methods in collaboration with cross functional teams to ensure manufacturing related defects are detected prior to product shipment
  • Ability for International business travel to support project implementation and collaborate with external vendors for product manufacturing
  • Demonstrated failure mode analysis, root cause investigation, and problem solving for product yield and quality issue
  • Understanding of manufacturing, and transition from development to mass production 

Requirements:

  • 6+ years’ experience in working developing processes for high volume products
  • Experience in a medical device or biotechnology industry
  • Experience in a FDA regulated industry, preferably a medical device is a plus
  • Proven successful project management leadership skills
  • Experience with plastics parts manufacturing including injection molding, joining/bonding methods
  • Experience in building manufacturing solutions for high volume low cost assemblies
  • Working experience in highly collaborative cross-functional disciplinary environment
  • Experience in managing relationships with outsourced contract manufacturers
  • Effective written and verbal communication skills across multiple levels of the organization; between peers, management and plant personnel
  • Effective systematic problem solving skills

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