Sr. Product Development Engineer

Integra LifeSciences Corporation is a world leader in developing and marketing high quality surgical instruments, as well as innovative devices and products for use in neurosurgery, reconstructive surgery, general surgery and soft tissue repair. In 2006, Integra grew revenues by more than 50% and surpassed $1 billon in market capitalization. We anticipate our significant growth to continue. In 2005 and 2006 Integra LifeSciences was named to the Forbes 200 Best Small Companies list, and has recently been named 2007 Medical Device Manufacturer of the Year by Medical Device & Diagnostic Industry Magazine.  Our rapidly growing company of over 2500 employees is currently seeking a highly accomplished individual committed to taking us to even higher levels of growth and innovation.  This position is located at our corporate headquarters in Plainsboro, New Jersey near Princeton.

 

SUMMARY DESCRIPTION

The Regenerative Technologies group at Integra is a leader in applying the principles of tissue regeneration to the development of medical products for neurosurgery and reconstructive surgery. Reporting to Director, Product Development this position will be responsible for leading teams in working with Marketing to identify new product opportunities, define specifications, and design and engineer  new products. This position will function as part of cross-functional project teams working on new product development in the Regenerative Technologies product development group.

 

ESSENTIAL DUTIES AND RESPONSIBILITIES

· Become an expert in Integra’s core technical competencies including collagen processing and surgical applications

· Develop excellent relationships with key surgeons in order to identify customer needs and opportunities for new products

· Lead and manage efforts to perform technical feasibility assessment of new product opportunities

· Work closely with Marketing, Sales, and customers to create prototype products and develop new product specifications

· Exhibit excellent communication skills in keeping senior management and the development team members informed about technical developments and issues

· Provide guidance for project team members in following Design Control procedures

· Effectively implement risk analysis and problem solving skills and techniques to identify potential issues, assess their impact, and develop and implement mitigation and resolution plans

· Develop and maintain an effective cross-functional working relationships with Project Management, Manufacturing, Plant Engineering, Regulatory and Quality Assurance

· Ensure that all appropriate technical documentation, drawings, specifications are generated in compliance with Integra’s procedures and statutory requirements (e.g. US FDA and ISO)

· Provide technical input for analysis of manufacturing or design changes to existing products

· Effectively plan experiments and analyze data utilizing experimental design and statistical analysis software.

· Effectively utilize Microsoft Office software to create reports, spreadsheets and presentations.

 DESIRED MINIMUM QUALIFICATIONS

· Education

§ Bachelors degree, preferably an advanced degree in Engineering or Chemistry

 

· Type and Number Years of ExperienceMinimum 5 years, preferably 10+ years of Product Development experience in medical devices with extensive experience with Design Control, GLP/GMP, and ISO regulationsDemonstrated history of technical creativity in product developmentFormal training or experience in implementation of Design Controls for Medical DevicesWorking knowledge of CADPrevious experience with medical devices derived from human or animal tissue is a plus TRAVEL

· Periodic International travel required as well as travel to and attendance at Medical Device Industry related events throughout the U.S. and Europe.

· Must be able to travel via car and/or airplane to domestic and international sites.

 

We are committed to creating an environment where all employees are valued and respected. We offer a competitive compensation/benefits package including 401(K) savings plan with match, medical, vision, dental, life insurance, tuition reimbursement and employee stock purchase plan. Please forward all resumes and salary requirements to: employment@integra-ls.com Please state Sr. PD Engineer in the subject line.

Website. http://www.integra-ls.com  Local candidates preferred. No agencies please. EOE, M/F, D/V