Manufacturing 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 billion 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 professional committed to taking us to even higher levels of growth and innovation.  This position is located at our Plainsboro Plant in Plainsboro, New Jersey near Princeton.

 

SUMMARY DESCRIPTION: 

 

Provides technical and engineering support to Manufacturing and Operations Departments.  Responsibilities include: project management, process improvement projects, assimilation of new products into the manufacturing process, tooling and equipment design/selection/procurement and installation, Manufacturing process troubleshooting, dispositioning non-comformances, CAPA investigating, and Lean implementation.

 

 

ESSENTIAL DUTIES AND RESPONSIBILITIES 

· Evaluates manufacturing processes and develops proposals to either correct identified problems or for process improvements.

· Researches product or process Non-Conformances and initiates corrective actions.

· Researches and conducts corrective actions for the plant Corrective & Preventative Action (CAPA) system.

· Implement Lean Manufacturing principles throughout the areas of responsibilities.

· Participate on project teams with other internal department members, external vendors and customers.

· Lead project teams, assemble information and satisfactorily complete projects within project timelines.

· Prepare and maintain project timelines using MS Project.

· Complete assigned projects following ISO and GMP’s, in a timely matter.

· Develop and maintain engineering drawings as required

· Develop standard operating procedures (SOP’s) to support validation and process improvement projects.

· Write and complete validation protocols (IQ/OQ/PQ).

· Maintain BOM’s and routings to ensure accuracy.

· Perform any other related duties as required. DESIRED MINIMUM QUALIFICATIONS

 

· BS in Engineering (Mechanical, Chemical or Industrial preferred)

·  0 to 3 years experience in the medical device or pharmaceutical industries

· Knowledge of Engineering Change Controls, ISO, QSR and Design Control Procedures

· Experience in clean room environment and or Lyophilization a plus

· Demonstrates excellent organizational and communication skills (oral and written)

· Demonstrated computer knowledge of Microsoft Office and Microsoft Project

· Experience in Lean Manufacturing concepts

 

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.

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