Senior Process Engineer

Job Description
Company Description

Integra LifeSciences, a world leader in medical devices, is dedicated to limiting uncertainty for surgeons, so they can concentrate on providing the best patient care. Integra offers innovative solutions in orthopedics, neurosurgery, spine, reconstructive and general surgery.

Integra's orthopedic products include devices and implants for spine, foot and ankle, hand and wrist, tendon and peripheral nerve protection and repair, and wound repair. Integra is a leader in neurosurgery, offering a broad portfolio of implants, devices, instruments and systems used in neurosurgery, neuromonitoring, neurotrauma, and related critical care. Integra is also a leading provider of surgical instruments to hospitals, surgery centers and alternate care sites, including physician and dental offices.

Founded in 1989, Integra is headquartered in Plainsboro, New Jersey and has over 3,000 employees worldwide. In 2010, Integra was included in both Forbes magazine's ""America's 100 Best Small Companies"" and NJBIZ's ""New Jersey's 50 Fastest Growing Companies.""

We value innovative thinkers who are open to new opportunities and derive satisfaction from knowing that their efforts are making a difference in someone’s life.



Detailed Description

Responsible for defining and implementing Manufacturing processes in new and existing plants, especially in the area of Biomaterial Manufacturing and Regenerative Technologies. Responsible for defining, selecting, and commissioning Manufacturing equipment.

Fundamental knowledge and practical application of Chemical Engineering processes, especially for Biomaterials
Ability to generate process flow maps and utilize results to improve processes and manufacturing operations.
Practical application of problem solving techniques related to definition of root cause and generation of corrective actions.
Perform timely technical investigations and provide practical manufacturing solutions, under appropriate regulatory guidelines for Medical Device Manufacture.
Work to gain expertise in Integra’s current technical proficiencies and manufacturing processes.
Lead and manage efforts to create novel processes for the prototype and full scale manufacturing of Integra Regenerative Technologies products and for the scale up of such processes..
Work closely with Development Engineers, Marketing, Sales and Clinical colleagues to ensure prototypes match the product concepts.
Lead teams in performing and updating Process FMECA risk management.
Effectively implement problem solving skills and techniques to identify potential issues, assess their impact and develop and implement mitigation and resolution plans and activities.
Develop and maintain an effective cross-functional working relationship with Manufacturing, Plant Engineering, Regulatory, and Quality Assurance.
Ensure that all appropriate documentation, drawings specifications are generates in compliance with Integra’s procedures and statutory requirements (US FDA and ISO).
Provide technical input for analysis of processes changes in the above areas.
Ability to create solutions by thinking outside the box.


Job Requirements

ESSENTIAL DUTIES AND RESPONSIBILITIES

BS in Chemical or Mechanical Engineering, or equivalent.

At least10 years experience in a medical device or pharmaceutical manufacturing environment.

Experience in Biochemical processes and equipment

Collagen chemistry and processing desirable.

Experience in clean room manufacturing environments

Experience with Quality System Regulation (QSR), Design Control and Process Validation guidelines.

Must be results oriented with a demonstrated passion for practical problem solving within a regulated medical device manufacturing environment.

Ability to interact cross-functionally is essential.

Exceptional practical problem solving skills,

Use of statistical process tools highly desirable. Minitab a plus.

Working knowledge of Lean Manufacturing, DFM and Six Sigma

How To Apply

We are committed to creating an environment where all employees are valued and respected. We offer a competitive benefits package including 401(K) savings plan with match, medical, vision, dental, life insurance, tuition reimbursement, and employee stock purchase plan.

To find out more about our company, visit our website at: http://www.integralife.com/Careers/

No Agencies. LOCAL CANDIDATES ONLY PLEASE. EOE, M/F, D/V

Integra is not currently accepting unsolicited assistance or resumes from search firms for this employment opportunity. All resumes submitted by search firms or agencies to Integra or its employees, agents, directors or representatives in any form or method without a valid written agreement covering this position will be deemed the sole property of Integra. No fee shall be paid in the event the candidate is hired by Integra as a result of the referral or through other means.

Search firms are essential to the recruitment and staffing efforts at Integra and we value the partnerships we have built with our preferred vendors. For this reason, Integra has established and regularly maintains a vendor list. Please note that even preferred vendors are required to have a written search agreement signed by an authorized signatory of Integra in order for a fee to be paid for any candidate referrals.

Company

Integra

Job Code

State or Province

New Jersey

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