Career Opportunities

Process Development Engineer

Posted on: Friday, September 20, 2013
Organization: Thermo Fisher Scientific
Location: Rochester NY
Description:

The Process Development Engineer develops process and manufacturing plans for new products from initial idea, through the approved design, procurement, process development/verification and successful implementation into manufacturing for Thermo Fisher Scientific. This includes activities related to generating plastic process solutions for new and existing product designs, process feasibility, product manufacturability and costs, project capital requirements and procurement in the life science/medical device, laboratory, packaging, diagnostic and bioprocess containers and consumer product markets.

Requirements include a strong background in plastic molding process technologies, materials, plastics manufacturing equipment, mold design, product specification and performance/application engineering, with involvement in the voice of customer (VOC) to ascertain product requirements (application, performance, ergonomics, safety, etc.), define process specifications, benchmark criteria and determine manufacturability for new products, while also supporting the maintenance of existing products.

The Process Development Engineer reports to the Product Development Engineering Manager, and is responsible for developing and successfully implementing innovative new product designs for the global laboratory and specialty consumable markets.

 

 

Responsibilities:

* Engineering Project Management: Responsible for managing engineering project activities and timelines, both internally and externally resourced, from concept through product launch.

* Concept Process Design and Development:  Responsible for reviewing product appropriate Design for Manufacturing (DFM) guidelines, determine process feasibility and development options, design reviews and evaluation of 3D models and 2D drawings for new and existing products, benchmarking competitive products and processes. Review product design and process specifications and development plans with appropriate mold makers, contract manufacturers, prototyping services, equipment or other service suppliers.

* Detailed Process Development:  Responsible for process development plans that conform to original new product design intent and specifications with regards to satisfying form, fit and function, robustness, performance life, manufacturability, safety, quality and cost optimization.  Apply failure mode analysis, process analytical tools, risk assessment, sound plastic part and mold design practices, reviewing alternate material options, etc.  Responsible for final manufacturing plans to meet part, product, mold and equipment requirements and specifications.  Develop project capital and product cost requirements and appropriations requests.  

* Verification and Validation:  Accountable for FAT, SAT, IQ, OQ, PQ involvement to ensure process verification and validation for molds and molding processes and equipment, including measurement and dimensional studies, generating quality inspection criteria, etc.  Assist in maintaining intellectual property rights for new processes.

* Communication: Communicates with Marketing, New Product Development, Industrial Design and other Operations team members to resolve process, mold and equipment details that differ from concepts or new product specifications.  Coordinates and presents manufacturing plans at design review meetings.

* Special Projects: Resource for technical projects that require functionality and DFM.  Work on special assignments and other projects as assigned by Manager that are deemed critically important for the business unit.

Requirements:

Minimum Requirements/Qualifications

* B.S. Degree in Mechanical or Plastics Engineering with minimum 6 years experience in plastics processing, materials, performance and applications, prototype engineering.

* Strong proficiency in engineering project and resource management, timelines and capital budgets.

* Strong proficiency in 3D CADD, SolidWorks preferred.  Understanding of mechanical drawing, solid model and mold flow comprehension.

* Demonstrated performance of process and manufacturing plans and product cost development for new products from concept through release to manufacture.

* Experience with mold, plastic resins and process equipment specifications, quotations, procurement and verification.

* Experience with mold design, plastic design analysis tools, design of experiments (DOE) and scientific molding practices.

* Experience in injection and/or blow molding of life science/medical devices and laboratory products desired.

* Work experience under Good Manufacturing Practice (GMP), ISO standards, Lean Manufacturing concepts and familiarization of FDA material regulations desired.

* Excellent technical skills including demonstrated project management, organization and planning.

* Ability to travel domestically and internationally (up to 25% of the time).

 

 

Professional Characteristics:

* Creative, innovative and critical thinking.

* Leadership qualities, analytical skills and troubleshooting disciplines.

* Results, solutions and task driven.

* Cross functional team oriented.

* Effective oral, written communication and presentation skills to all organization levels, internal and external.

* Excellent documentation and organizational skills.

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