Job Openings >> Manufacturing Engineer
Manufacturing Engineer
Title:Manufacturing Engineer
Location:Buffalo, NY
Nissha Medical Technologies is looking for a Manufacturing Engineer to join our growing team! 
This role requires a technical engineer expert to be responsible for design, manufacturing development, and transferring new products to production as well as direct and coordinate engineering activities for multiple projects. This position will assist and recommend 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. Knows and applies fundamental concepts, practices, and procedures of particular field of specialization. Act as the lead subject matter expert in all the above areas and represent the Development Engineering group in this capacity.

Essential Job Functions
1. Creates production specifications (drawings, specifications, manufacturing assembly instructions, work instructions, etc.) based on customer requirements.
2. Provides input for customer product design changes.
3. Designs manufacturing equipment, processes, tooling, and fixtures.
4. Creates project development plans, product specifications, conceptual designs and manufacturing concepts.
5. Selects materials based on customer requirements and Biomedical Innovations capabilities.
6. Provides design, process, and material related input related to products and manufacturing processes.  
7. Generates Test Reports, Drawings, Procedures, Routers, Specs, DCO’s, ECO’s, and other Technical documentation.
8. Creates Component and Process Qualification and Validation plans.
9. Facilitates initial tooling trials.  Troubleshoots tooling performance, process performance, design and material related issues during manufacturing start up.
10. Facilitates or performs process characterization (DOE) and process validation on processes/products according to CEA’s procedures and / or customer requirements.
11. Provides quotation for potential new products, which includes selection of materials, processes, tooling, equipment, and resources.  
12. Participates / leads various project teams and conference calls while representing CEA to the customer.
13.Validates manufacturing processes. Facilitates or performs process characterization and process validation on components/products according to Biomedical Innovation’s procedures and / or customer requirements.
14. Participates in fabrication of prototype, first article samples, and test equipment.
15. Participates in project teams and conference calls while representing Biomedical Innovations to the customer.
16. Generates engineering change orders, protocols, and reports. Creates work instructions (WI’s) and standard operating procedures (SOP’s) for products, and machines for new customer processes
17. Assists manufacturing engineering with current product process improvements as required. Participates in design reviews to modifications to processes. 
18. Coordinates and performs design reviews with manufacturing engineering of new customer processes through the RTM process. 
19. Works with the Automation Engineering group as needed to evolve products/processes into full automation assembly.
20. Troubleshoots electrical, mechanical and software for machine and system use as required.
21. Trains, mentors other technicians and engineers.
22. Trains Production personnel in product assembly and inspection.
23. Author and/or drive initiatives to evoke process improvements within the group and throughout engineering.
24. Represent the group as the authority when needed.
25. Contribute to the career performance and advancement planning/evaluations of engineers within the group.
26. Abides by all safety and security rules set forth by the company and regulatory agencies.

  • BS in Manufacturing or Mechanical Engineering. MS degree in Engineering preferred. 6+ years of work experience in Manufacturing or Process Engineering may substitute for the education requirement.
  • 5 years or more progressive experience in Manufacturing or Process engineering required
  • 8 years progressive experience in manufacturing
  • Recognize technical expert in relevant engineering area (Manufacturing, Design, and Development)
  • Successful experience in technical leadership role.
  • Experience working in highly regulated environment.
  • Ability to plan activities, work independently, and complete work on schedule.
  • Experience with equipment and/or process qualifications and validations (IQ,OQ, PQ) 
  • Solid interpersonal, communication, and leadership skills and ability to work in a team environment 
  • Industrial automation experience desired
  • Mechanical and machine shop ability desired
  • General office application computer skills required
  • Strong working knowledge of 3D CAD (SolidWorks preferred)
  • Understanding of Lean Manufacturing processes.
  • Experience designing and conducting DOEs using Minitab desired. 
  • Strong problem solving skills and efficient management of time and resources.
  • Experience with quality standards such as ISO 13485, ISO 14971, FDA 21 CFR Part 11
  • Experience designing and conducting DOEs using MiniTab.
Knowledge, Skills, & Abilities
  • Strong interpersonal and teamwork skills in working with employees, customers and other departments.
  • Strong communication skills with the ability to explain complex information in an understandable language.
  • Detail oriented and accurate.
  • Ability to multi-task and prioritize.
  • Flexible in responding to procedural changes and department/ employee needs and issues.
  • Strong analytical skills with the ability to resolve problems by gathering necessary information in order to make and effective resolution.
  • Ability to remain calm under pressure.
  • Creative and visionary in order to envision equipment and processes needed for new products.
  • Initiative and self-directed
  • Patience in dealing with employee and interdepartmental issues.
  • Strong reading and comprehension skills required.
  • Accountability
  • Dependability
  • Ability to follow instructions with little supervision and to provide timely updates to co-workers and management.
Nissha Medical Technologies is an Equal Opportunity Employer and considers applicants for all positions without regard to race, color, religion, creed, gender, gender identity, gender expression,national origin, age, disability, marital or veteran status, sexual orientation or any other legally protected status. In addition, NMT will provide reasonable accommodations for qualified individuals with disabilities.
If you need assistance with completing the online application process, please call 716-849-6360.
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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
The OEM trademarks identified herein are the trademarks of the respective OEMs, and not Nissha Medical Technologies. Nissha Medical Technologies disclaims any affiliation, connection or association between it's products and those of the respective OEMs.