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Process Development Engineer in Bothell, WA at Volt

Date Posted: 12/5/2018

Job Snapshot

  • Employee Type:
  • Location:
    Bothell, WA
  • Duration:
    48 weeks
  • Date Posted:
  • Job ID:
  • Contact Name
    Volt Branch
  • Phone

Job Description

Process Development Engineer  

This startup company located in Bothell, WA which is a rapidly growing international medical device manufacturer headquartered in Narvik (Norway), with offices in Oulu (Finland) and Florida/Seattle (USA) is seeking a Process Development Engineer for a temp to hire role. The company entered both the US and EU markets in 2018.

The company’s hand-held app-based ultrasound concept is innovative, user-friendly, affordable, intuitive and wireless designed for use in multiple medical segments. The selected candidate is responsible for supporting research and development, manufacturing and quality system activities of new product designs including review of existing manufacturing production lines and plan cost-effective production manufacturing/quality processes and issues.

He/she helps establish specifications to ensure the company products conform to performance and quality standards. He/she works directly with QA to define and implement inspection activities and to enforce requirements as specified by design specifications and regulatory agencies. He/she is responsible for following established the company’s CCP/CMP/ISO/MDD/HIPPA compliant quality system practices and completing all specific training requirements. The process development engineer assists in the seamless transition of new product projects from concept through commercial introduction and full-scale manufacturing with the responsibilities of working closely with the quality team to review manufacturing results, develop corrective resolutions in a highly repeatable process that will optimize manufacturing productivity and product quality, while minimizing waste in terms of time and materials. Production/Engineering support at a client in Everett, WA. Provide technical support for continuous improvement of new and existing processes. Work cross functionally with Norway, Finland and Seattle Teams. Conduct process and product validations. Provide technical assistance for diagnosing manufacturing quality problems. Receiving and inspection of manufactured components and assemblies. Assist in the design and development of the company’s products providing technical support for continuous improvement to new and existing processes with the ability to troubleshoot, define root cause, provide resolution and implement necessary changes efficiently and timely in an FDA regulated environment. Run and monitor life cycle testing. Record study data.

Prepare and test samples. Develop and implement processes for development and manufacturing. Provide technical assistance for diagnosing manufacturing quality problems. Assist in transitions from design to development and development to manufacturing. Receiving and inspection of manufactured components and assemblies. Work with Contract Manufacturing vendors to develop and optimize the company processes. Assist in documenting test plan protocols, standard operating procedures, specifications and test procedures. Other duties and responsibilities as assigned whether due to a work surge or regular assignment. Team member on special projects and performs additional duties as assigned.

Job Requirements:

The ideal candidate should possess a Bachelor's of Science degree preferred; preferably manufacturing, mechanical, electrical or chemical engineering. Combination of education and experience acceptable. Additional certifications such as Six Sigma, Lean Manufacturing and/or various manufacturing design, Project Management, etc. are desired.

Must have a minimum five (5) years’ engineering experience with preferred knowledge of FDA, GMP, and ISO 13485; with a minimum of one (1) years responsibility as a process development engineer or equivalent. Working understanding of all phases of product manufacturing including process engineering, validation. The ability to analyze and present information to a diverse team including customer/vendor interactions. Highly organized and results-oriented skills with the ability to work with the company’s internal cross functional teams and external clients in a fast-pace, emerging growth organization. Exceptional time management meeting corporate and departmental objectives. Ability to interpret and analyze complex/detailed data.

Excellent communication skills to effectively present information both orally and in writing to diverse groups. Good interpersonal skills with the ability to resolve problematic resolution issues quickly and efficiently. Ability to make timely and quantitative decisions. Ability to persuade and motivate others. Professional appearance and presentation required. Ability to work within defined budgets. Pro E or Solid Works knowledge preferred. Proficiency in Microsoft Office. Typical office equipment/tools including but not limited to phones, copier/faxes.

Volt is an Equal Opportunity Employer