Product Development Scientist - Medical Products

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POST DATE 9/14/2016
END DATE 10/13/2016

Engineering Resource Group, Inc. Hackettstown, NJ

Hackettstown, NJ
AJE Ref #
Job Classification
Full Time
Job Type
Company Ref #
Min Salary
Max Salary
Salary Unit
per year


Permanent position for a Product Development Scientist for characterization of assays and raw materials for coagulation products.Develop, participate and manage product development activities for the department. To include design of experiments and hands on bench work.Work with department head in developing new products, pilot runs and scale ups of new products.Manage regulatory requirements, design control and cGMP requirements in all aspects of product modifications and product development work.Liaise with customers (internal and external) regarding progress of projects as assigned.Develop and assist in validation of equipment and products to meet all regulatory and quality requirements.Develop performance measurement tools (including statistical) to analyze projects.Liaise with customers and provide any relevant technical information, root cause analysis, and product investigation of customer issues.Prepare and prepare technical product analysis for use by customers (internal and external).Participate in raw material selection and qualification for existing and new products.Responsible for sound scientific strategy to support regulatory acceptance of all new and existing products.Work with sales team to evaluate new products, customer concerns and provide technical support.Review literature, attend scientific symposia where possible and build relationships with industry experts to trouble shoot, recommend and/or develop new product lines.Assist in developing and maintainin


MS or BS in Engineering or Life ScienceMinimum 5 years related experience
and training in coagulation related field.Experience in IVD industry assay
development preferred.Valid Passport.Travel requirements Up to 25%, about
10% international travel and trade shows.

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