Nonin Medical, Inc.

Returning Candidate?

Manufacturing Engineer

Manufacturing Engineer

ID 
2018-1180
# of Openings 
1
Job Locations 
US-MN-Plymouth
Category 
Engineering
Type 
Regular Full-Time

More information about this job

Overview

Primary Objective:

This position will provide engineering support for the manufacturing of products through the development, evaluation, documentation, and improvement of products and manufacturing methods to meet product quality, corporate objectives, and customer requirements. This position will drive to optimize existing manufacturing processes and equipment and ensure new products are designed for manufacturability.

Responsibilities

Essential Job Functions:

 

  • Identify product design and process improvements, justify, implement and validate solutions to accomplish cost, quality and schedule goals for new and existing products. Represent manufacturing on new product cross-functional teams to accomplish design for manufacturability goals to ensure compliance with good manufacturing practices, safety, quality standards, and customer needs.
  • Develop manufacturing processes for new products, product changes and enhancements, and related tooling and fixtures that support a Lean manufacturing environment.
  • Work with Design Engineering to identify production test requirements, develop and maintain production test software (LabVIEW), and hardware for manual and automated test systems.
  • Develop and maintain the documentation necessary to ensure the consistent manufacture of products (processes, drawings, routings, and maintenance).
  • Provide engineering support for troubleshooting of process or product issues, including root cause failure analysis of discrepant materials and assemblies, including CAPA activities.
  • Write and perform electrical, mechanical, material and equipment tests, gather data, interpret results, and write reports.
  • Train manufacturing employees on new and revised products, tooling and processes.
  • Specify and procure equipment and oversee outside vendor activity as required.
  • Successfully works with new technologies and methods on new designs and upgrades to existing designs.
  • Promote and leads Lean Manufacturing and Continuous Improvement activities in Manufacturing.
  • Complete process and test system validations to meet applicable FDA and regulatory requirements.

 

Qualifications

 

Required Education & Experience:

  • Bachelors Degree in Engineering, Biotechnology, Computer Science, Engineering Technology or equivalent technical Degree; pr equivalent combination of education and experience.
  • 0-5 years of related experience.

 

Required Knowledge, Skills & Abilities:

  • Experience in manufacturing environment.
  • The ability to work with minimum supervision, prioritize and manage workload, and complete tasks on schedule.
  • Strong oral and written communication skills along with proficiency in Microsoft Office Suite
  • Ability to write technical reports, business correspondence, technical and administrative procedures.
  • Strong team player, works well with all levels of employees, collaboratively and respectfully in a team environment.
  • Understands engineering principles theories, concepts, practices and techniques and applies them to daily activities.

 

Preferred Qualifications:

  • Manufacturing experience in a medical device environment including understanding of ISO13485 and FDA QSR, Proven project management skills.
  • 5S and Lean manufacturing experience.
  • Application of statistical and analytical methods such as SPC, DOE, and FMEA

 

Physical Requirements:

Ability to sit/stand/walk for up to 8 hours/day