Job Openings >> Process Engineer I/II
Process Engineer I/II
Title:Process Engineer I/II
Location:Sandpoint, ID
Nissha Medical Technologies is looking for a mid-level Process Engineer to join our Engineering team in Sandpoint, Idaho. The position will be responsible for supporting design, manufacturing development, and transfer of new products to Production. This position will assist in the selection and specification of new assembly or automated equipment. Responsible for the design, testing, and integration of manual and semi-automated processes / equipment needed to support new customer products. Coordinate and perform process validations per ISO 13485 and FDA requirements. The successful candidate will be expected to know and apply fundamental concepts, practices, and procedures of particular field of specialization.

Essential Responsibilities:
  • Continuous Improvement and Cost Reduction: Continually improve manufacturing methods/systems and process/product improvements to optimize product performance and reduce manufacturing costs. Identify and evaluate opportunities for improvement and make specific recommendations for adoption.
  • Assist in performing line throughput and bottleneck analysis to optimize line and reduce product costs.
  • Qualification and Validation: Assist in developing plans to evaluate process repeatability and stability through equipment qualification and process validation. Apply appropriate statistical methodologies.
  • Assist in generating: Test Reports, Drawings, Procedures, Routers, Specs, DCO’s, ECO’s, SOP’s and other Technical documentation.
  • Create production specifications (drawings, specifications, manufacturing assembly instructions, work instructions, etc.) based on customer requirements.
  • Assist with designing manufacturing equipment, processes, tooling, and fixtures.
  • Provide input and adheres to project development plans, product specifications, conceptual designs, and manufacturing concepts.
  • Provide design, process, and material related input related to products and manufacturing processes.
  • Assist in creation of Component and Process Qualification and Validation plans.
  • Facilitate initial tooling trials. Troubleshoots tooling performance, process performance, design and material related issues during manufacturing start up.
  • Provide quotation for potential new products, which includes selection of materials, processes, tooling, equipment, and resources.
  • Coordinate and perform design reviews for new customer processes through the RTM process.
  • Work with the Automation Engineering group as needed to evolve products/processes into full automation assembly.
  • Troubleshoot electrical, mechanical and software for machine and system use as required.
  • Train production personnel in product assembly and inspection.
  • Regular attendance.
  • Abide by all safety and security rules set forth by the company and regulatory agencies.
Minimum Requirements:
  • BS degree in Mechanical Engineering  (Equal experience in Manufacturing or Process Engineering may substitue for education on a year for year basis), AND
  • Minimum 1 year experience in an entry level engineering position at NMT or 2 years of external engineering experience is required.
  • Experience working in a highly regulated environment
  • Experience with equipment and/or process qualifications and validations (IQ, OQ, PQ)
  • Mechanical and machine shop ability desired
  • Strong working knowledge of 3D CAD required (Solidworks preferred)
  • Understanding of Lean Manufacturing processes
  • Experience with quality standards such as ISO 13485, ISO 14971, and FDA 21 CFR Part 11
  • Strong interpersonal, teamwork, and communication skills with the ability to explain complex information in an understandable language
  • Ability to plan activities, work independently, and meet deadlines
  • Strong analytical and problem solving skills.
Great benefit package including medical, dental, 401k with company match, education assistance, and more!

We do not offer sponsorship.

Nissha Medical Technologies is an Equal Opportunity Employer and considers applicants for all positions without regard to race, color, religion, creed, gender, gender identity, national origin, age, disability, marital or veteran status, sexual orientation, or any other legally protected status. In addition, Nissha Medical Technologies will provide reasonable accommodations for qualified individuals with disabilities.

If you need assistance with completing the online application process, please call Human Resources at (208) 263-5071.
This opening is closed and is no longer accepting applications
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Nissha Medical Technologies
400 Exchange Street
Buffalo, NY 14204
Nissha Medical Technologies is the medical devices business unit and wholly owned subsidiary of Nissha Co. Ltd., a Japanese publicly held company based in Kyoto, Japan (TSE:7915).
Copyright 2020 Nissha Medical Technologies. All rights Reserved
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