Biomaterials Research Engineer

Kensey Nash Corporation (NASDAQ, KNSY) is a medical device company known for providing innovative product development and advanced technology for a wide range of medical procedures. The Company has expanded well beyond its beginnings in vascular puncture closure and today provides an extensive range of products into multiple medical markets. We need your expertise as we continue to grow.

The Biomaterials Research Engineer will assume Kensey Nash products are of consistent and high quality by assuming responsibility for duties related to the KNC Biomaterials Development function in compliance with GMP and ISO standards.

Principal Duties Include:Develop new Biomaterials-Based products, assist with product design and specification, and build demonstration prototype medical instruments from minimal product descriptionsSupervisor test protocol design, test fixture, design equipment procurement, and the tests themselvesAssist with refinement of prototype designs to achieve product maturity with products that can meet performance specifications and cost targetsProcure materials for laboratory tests and human clinical trials from outside labs and universities, attend clinical trials as necessaryMaintain records for compliance with GMPsComply with all FDA regulations with regard to medical device product developmentResearch new biomaterials opportunities; submit drafts for grants and patent filingsAttain and maintain a working knowledge of anatomy, physiology, and surgical intervention procedures to allow optimization of product designManage customer accounts and perform associated tasks and activitiesAssist in transition of lab-scale processes into full-scale production processesAssist with validation efforts as they apply to biomaterials production processes and equipmentParticipate in project meetings and provide engineering inputEnforce GMP/ISO Product Development Procedures relating to biomaterials products within the KNC organization and support Audit Activities where applicablePrepare applicable technical sections of regulatory documents (510k IDE, PMA) for KNC products as assigned; contribute to clinical trial protocol preparation.

Qualified candidate will have B.S. degree in Biomedical Engineering, Biology, Chemistry or related field; 1-5 years experience in development of biomaterials-based medical products or a related industry; excellent written and oral communication skills; ability to lead and/or function as part of a team; computer literacy; understanding of engineering concepts; understanding of anatomy and surgical procedures.  Position requires to spend significant amount of time in production areas and R&D labs; handling lab chemicals and other potentially hazardous materials while wearing appropriate safety attire which may include lab coat, gloves, goggles, mask, respirator, etc. Occasional travel will be required. 

We offer an attractive compensation/benefits package, a creative working environment and an opportunity to join a strong team of highly skilled individuals.

 

Check out our website! www.kenseynash.com

 

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ONLY APPLICANTS WHO SUBMIT SALARY REQUIREMENTS WILL BE CONSIDERED FOR THIS POSITION