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Process Development EngineerPosted by: Ativa Medical
Posted date: Dec-17-2015
Location: St. Paul, MN
Process Development Engineer Position
We are seeking an experienced process development engineer who has worked in high volume disposable manufacturing in a regulated environment. This position will collaborate with design, quality and manufacturing to transition new products from development to full scale manufacturing. Key responsibilities include characterizing and identifying key process variables and design variables to ensure a low cost robust manufacturing process. Additional duties will include participation in risk assessment activities of the manufacturing process and identifying mitigation solutions as needed.
Primary Duties and Responsibilities:
Qualifications (Knowledge, Skills & Abilities):
· Strong knowledge with industry standards (including ISO 13485 & 14971, FDA QSR)
· BS in Mechanical Engineering or a related field
· Analytical and creative thinker with experience with statistical methods
· Effective oral and written communication skills
· Demonstrated organizational and administrative skills.
· Ability to prioritize and handle multiple tasks.
· Demonstrated problem-solving skills
· Experience with polymers and adhesives
· 5 - 7 years’ experience as a process development engineer in an IVD medical device environment