Validation Engineer (Contract) – Kalamazoo, MI
DISHER is currently looking for a Validation Engineer for our medical device customer in Kalamazoo, MI. This can be a direct hire or contract role anticipated to last about 3 years.
In this role you will manage, inspect, calibrate, test, and modify the instrumentation, equipment, mechanics, and procedures used to manufacture many products.
What it’s like to work here:
Our customer is a global leader in medical technologies and, together with their customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, our customer impacts more than 150 million patients annually.
What you will get to do:Provide engineering support for new product and process introductions, ensuring that all activities are completed and documented in accordance with the company's new product development proceduresEnsure quality of process and product as defined in the appropriate operation and material specificationsSelect components and equipment based on analysis of specifications, reliability and regulatory requirements. Work with quality engineers to develop component specific testing and inspection protocols.Lead/support capital acquisition activity from specifying equipment, contract negotiation, Installation and validation.Work with quality engineers to develop component specific testing and inspection protocolsAnalyze equipment to establish operating data and conduct experimental test and result analysisLead process review meetingsLead PFMEA, Control Plan, SOP and PPAP generation associated with product transfers and launchesComplete capability studies for in process inspection and generate subsequent inspection documentationConduct process validation and MSA studies for new products and new processesWork in a hands-on manner at the manufacturing site to lead the implementation of new processes as specified in developmentProvide training for manufacturing team membersEnsure adherence to GMP and safety proceduresReview and approval of validation documentationWhat will make you successful:Bachelor's degree in engineering required4+ years of applicable work experience requiredSpecialization or work experience in plastics or polymersExperience in working with medical devices is preferredWorking knowledge of PFMEA requiredExcellent analytical skills, ability to plan, organize, and implement concurrent tasks requiredGood knowledge of validation and manufacturing processes, materials, product and process design requiredAbility to read and interpret complex engineering drawings and understand geometrical dimensioning and tolerancing (GD&T) requiredCAD experienceHold a current and continuing right to work in the U.S. without restriction or sponsorshipDISHER is a nationally recognized engineering, manufacturing technology, and technical recruiting firm based in Zeeland, Michigan. Our diverse team of top talent comes alongside clients within multiple industries to solve their unique challenges. DISHER truly is a great place to work. Our mission? To Make a Positive Difference with our customers, coworkers, and communities. Every day we strive to leave this world better than we found it. It is what motivates our caring team and unifies our culture.
