Product Development Engineer II

Cook Biotech Inc is hiring for a Product Development Engineer II position and is open to consider both onsite and remote candidates. The person in this position has responsibility for completing the required activities intended to uphold and maintain Design History Files and Risk Management Files in response to regulatory inquiries and product feedback. This 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 Activities, Design Verification/Validation Activities, Bench Testing, and maintaining Design History Files and Risk Management Files in accordance with Quality System Documents.

• Areas of Responsibility
• Responsible for sub-projects related to the primary functional areas listed above.
• Technical Knowledge
• Demonstrated knowledge of Cook Biotech Quality Systems.
• Demonstrated experience in applying ISO 13485 and ISO 14971 principles for executing job responsibilities.
• Demonstrated ability to identify and apply external standards as required for the job function.
• Decision Making
• Uses experience and judgement to recommend path forward.
• Consults with senior team members and supervisor for decisions as needed.
• Collaboration
• Works with the local team and has become established as a collaborator with other functional areas.
• Change/Innovation
• Identities and records improvement opportunities.
• Identifies improvement opportunities within the Quality System.
• Submits change orders for Quality System improvements.
• Submits invention disclosures with other team members.

• Master's degree in Biomedical Engineering, Chemical Engineering, or related scientific field, or a Bachelor's degree with applicable experience.
• Ability to design and execute experiments intended to support feasibility and development efforts
• Good documentation skills with the ability to appropriately record laboratory activities
• Able to write laboratory protocols and reports, as well as perform data analysis
• Experience with application of statistical methods (t-test, ANOVA, confidence limits, tolerance intervals).
• Experience in laboratory and familiar with lab equipment, manufacturing equipment, and manufacturing processes common for biomaterial processing
• Good task and time management skills with the ability to work on multiple projects simultaneously
• Project management skills; able to effectively communicate task status and project updates to team member, management, and other stakeholders .
• Able to receive and appropriately act upon ideas, suggestions, and feedback from peers, managers, and other stakeholders
• Willing to work with material derived from animal tissues
• Sufficient background to generally understand medical and biotechnology terminology.
• Able to work both independently and as a member of a team depending on the needs of the project

Physical Requirements:

• Must be able to perform the essential functions of the job
• Limited exposure to hazardous chemicals used in the manufacture of the product
• Physical demands are typical of an office and laboratory environment

Employee Requirements:

Sign non-competition and confidentiality agreements. Compliance with all policies of the company including without limitation the COOK Employee Manual,
COOK Code of Conduct, COOK Electronic Information Policy, HIPAA regulations, and COOK Policy & Guidance on Interaction with Healthcare Professionals.