Product Development Engineer II

The person in this position has responsibility for completing required activities to maintain and improve design history and risk management files in response to regulatory inquiries and product feedback.  This Cook Biotech Inc. position also has responsibility for creating and updating product designs to meet clinical needs and customer requirements.  Primary areas of responsibility include design changes, risk management updates, design verification/validation activities, bench testing, and maintaining documentation in accordance with Cook Biotech’s Quality System. Cook Biotech

• Work as a member of various project teams under direction of the Engineering Manager to improve and add to Cook Biotech’s product portfolio 

• Conduct product development activities for new and modified designs according to the CBI Quality System procedures and instructions 
• Gather critical information pertaining to the clinical application of a medical device as an input to performance requirements and end-user needs 
• Design, coordinate and/or execute design verification and validation testing activities 
• Conduct design risk analyses according to CBI Quality System procedures and instructions 
• Develop and implement product specifications and manufacturing documentation 

• Effectively communicate project updates to team members, management, and other stakeholders 
• Remain current on and apply requirements from 21 CFR 820, ISO 13485, ISO 14971, ISO 62366, and ISO 10993 while carrying out duties 

• Master’s degree in Biomedical Engineering, Chemical Engineering, or related field, or a bachelor's degree with applicable experience 
• Candidates with at least 3 years of industry experience strongly preferred 

• Candidates with industry experience in medical device development strongly preferred 
• Proven ability to design and execute experiments intended to support feasibility and development efforts 
• Good documentation skills with the ability to appropriately record complex laboratory activities 
• Experience with application of statistical methods (t-test, ANOVA, tolerance intervals, Gage R&R). 
• Experience in a laboratory setting and familiar with lab/manufacturing equipment and medical device manufacturing processes  

• Able to work both independently and as a member of a team depending on the needs of the project 
• Good task and time management skills with the ability to work on multiple projects simultaneously 
• Able to effectively communicate task status and project updates to team members, management, and other stakeholders 
• Able to receive and appropriately act upon ideas, suggestions, and feedback from peers, managers, and other stakeholders 

Physical Requirements

• 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 or biohazards.  May work in a Biosafety Level II lab.
• Must be able to perform the essential functions of the job, with or without reasonable accommodations
• Limited exposure to hazardous chemicals or biohazards.  May work in a Biosafety Level II lab.