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Design and Validation Engineer

1 month ago

Portage, United States iMPact Business Group Full time
Job Description

Our client, a Global Leader in the Medical Device Industry has an immediate opening for a New Product Developer Design and Validation Engineer for a 6 month + Contract. Our client offers results-driven people a place where they can make a difference - every day You will also have the opportunity to work with other like-minded, self-directed and detail oriented Top Talents in an extremely collaborative and professional environment.

One Candidate will be support project Design of experiments OQ/PQ. Second Candidate will be responsible for development and validating the Process/Software/Applications for the production Equipment.

Top 3 must haves to perform the Job:
  • Layout Experience
  • Equipment Validation
  • Minimum of 2 years; 3 or more preferred experience.
Position Description (Principle Duties and Responsibilities)
  • Designs, validates and will bring new products to market.
  • Specifies precise new product functional requirements; designs, tests and integrates components to produce final designs; and evaluates the design's overall effectiveness, cost, reliability and safety.
  • Designs, develops, executes and evaluates fitness-for-use testing, product specifications and process validation plans; creates and reviews material part specifications and bills of materials.
  • Collaborates with internal manufacturing partners, contract manufacturers, designers and product specialists to optimize designs for manufacturability.
  • Utilizes CAD (Computer Aided Design) or CAE (Computer Aided Engineering) systems to model new designs and produce detailed engineering drawings.
Job Requirements

Requirements
  • Bachelor's degree; in engineering or applicable technical field (mechanical or biomedical preferred) (M.S. or/and Ph.D. in Engineering or related field welcomed)
  • 5+ years' of medical device design and development experience or electro-mechanical appliance or equipment
  • Proven track record of collaborating with others to design and develop high priority medical technologies, preferred
  • Supplier/Vendor Management will be a key function of the job will work very closely with external vendors procuring the parts and ensuring those parts meet specifications.
  • Emphasis Process Validation..requires experience looking at and entire manufacturing assembly process and validating the whole process (pFMEA, Risk Analysis, Process Control Plans)
  • Production Part Approval.
  • Team player, quick learner, problem solver, self-motivated.
  • Any experience working with Pressure Leak systems will be a huge asset
  • Plastics Joining Welding experience will be preferred
  • Excellence. Dedication. Passion.