CSV/Validation Engineer – On site in Kalamazoo, MI

MUST BE ABLE TO WORK ON A W2

Product - laser marking - printers

This is part of the EU MDR & Guardian Project internally at Client

3 years of validation experience for both

Electrical Engineer degree would be nice, validation exp in medical device is preferred!

1

Develop files and validate them for laser marketing

New and existing files - development and validation of the products

70% is developing the laser marking files – has an application to develop the file – not writing the program but using the program to design the files used to make the files.

NOT deveopling or writing – will be provided information

2

CSV - validating software updating equipment to new versions and updating/validating systems - checking the systems are updated

One Candidate Will be in charge of Laser Marking updates on multiple products. Second Candidate will be responsible for Validating the Software/Applications for the production Equipment.

Top 3 must haves to perform the Job:

• Layout Experience
• Equipment Validation Software Knowledge: AutoCAD
• MS Project Minimum of 2 years; 3 or more preferred experience
• No specific industry experience needed.

Job Summary: Designs, validates and brings 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.This is an individual contributor role that requires the use of judgement in applying professional expertise and is expected to work independently with minimal supervision. Roles typically require a university degree or an extensive amount of practical knowledge gained through experience. Job requires an understanding and application of procedures and concepts of own discipline. The job requires attention to detail in making evaluative judgements based on the analysis of factual information. This job typically requires a degree or equivalent and a minimum of 2 or more years experience.

Term and start

• month initial contract
• 5 days a week in Kalamazoo, MI
• rate: $60-70/HR Based on experience