Senior Process Engineer, Medical Device

Plainsboro, New Jersey, United States

Posted on 11/09/2019 by Shurig Solutions, Inc.

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Position Details




Healthcare / Medical Devices


Biotech / R&D / Science

Job Level:

Experienced Professional (Non-Manager)


Bachelor's Degree


$110-$125k base, bonus opportunity & relocation assistance

Reference ID:


Our client is a world leader in medical technology; offering innovative solutions in orthopedic extremity surgery, neurosurgery, and reconstructive and general surgery for over 35 years.  We are supporting them for a Senior Process Engineer to work as part of a cross-functional team (Manufacturing, QA/QC/RA, Engineering, Facilities, Materials Management, Finance, Marketing) to transfer implantable collagen-based products/processes from R&D to full-scale manufacturing, following Design Control Procedures.  This position will lead full-scale manufacturing for regenerative products and perform hands-on laboratory work for prototyping, testing, DOE to optimize and scaleup processes from R&D to full-scale manufacturing. Development of specifications for new processes. 

The Right Talent:

BS in Chemical Engineering, Mechanical Engineering, Pharma or relevant degree 

7+ years of engineering experience in medical device or pharma 

Experience with tissue processing a must

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

Experience with DOE and SPC 

Knowledge of validation fundamentals (IQ/OQ/PQ), statistics and process capability (CpK, sampling methodologies, etc)

Experience in clean rooms, lyophilization or biomaterials are desirable

General chemistry, biological tissue processing and materials expertise

Strong problem solver with excellent communication skills 

No Visa Transfers or Sponsorship, Please


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