Cook Medical Product Life Cycle Engineer II in West Lafayette, Indiana
The Product Life Cycle Engineer II position at Cook Biotech, Inc. has responsibility for supporting products life cycle management to existing products and other related duties as determined by the CBI Quality System.
• Perform risk analysis updates• Review complaints analysis and document effect on risk profile• Update risk management reports, and conduct residual risk review• Perform Type-1 design changes as required• Create and complete quality plans for specific types of design changes• Review impact of changes and update design traceability matrix when required• Solicit input from engineers, quality assurance, regulatory affairs and manager to identify and mitigate product life-cycle data deficiency
• Write device and package testing protocols and reports• Conduct testing as needed• Work as a team member on individual and multi-member team projects• Conduct assessment of business risk for product life-cycle management• Communicate project status, hurdles and propose next steps to all stake holders• Remain current and apply the understanding of FDA-ISO 13485 and quality system requirements in carrying out duties• Remain current and apply the understanding of ISO 14971
• Bachelor's degree in Engineering or related field• Two (2) years previous experience in medical industry or related field OR equivalent higher education, preferred, but not required• Experience in medical industry preferred, but can be substituted with experience in any product life-cycle management• Able to work independently and on multidisciplinary teams• Excellent task management skills and able to work on multiple projects simultaneously• Ability to conduct bench tests
• Able to effectively listen to ideas and concerns coming from experience engineers and other CBI stake holders and incorporate suggestions appropriately• Able to effectively communicate task/project status and ideas to stake holders• Good record keeping and documentation skills• Willing to work on documentation and writing heavy tasks• Willing to work with material derived from animal tissues• Sufficient background to generally understand medical and biotechnology terminology
• Must be able to perform the essential functions of the job, with or without reasonable accommodations• Limited exposure to hazardous chemicals used in the manufacture of the product
• Physical demands are typical of an office and classroom environment
Job Location(s)West Lafayette IN United States
Position TypeFull Time
CompanyCook Biotech Inc.