Job Description

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $25 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them.

The Process Development Engineer, Injection Molding role is part of the Research and Development team within the Laboratory Products Division (LPD) which unites deep scientific expertise, a collaborative culture and rich resources to deliver the lab consumables that our customers need to achieve their scientific goals quickly, reliably and safely. Our smart lab solutions make it faster and easier for our customers to focus on what matters most delivering answers and innovations that save and improve lives. This role will reside in Petaluma, CA.

How will you make an impact?

The Plastics Process Engineer will provide process engineering and tooling support for injection molding related projects. Includes hands-on process/tooling troubleshooting, process optimization using scientific molding principles, coordinating tooling repairs & procurement, process and component validations, cost savings initiatives, and equipment specification and implementation. Make an impact for your career, our customers and the world with this exciting opportunity for a talented engineer. Collaborate with others like you to drive innovation, implement new design technology and develop best engineering practices in a growing organization.

What will you do?

* Hands-on injection molding process and tooling troubleshooting.
* Develop molding processes and parameters for new and improved products to maximize quality and production.
* Process optimization following scientific molding principles following good documentation practice.
* Define and perform validations using IQ/OQ/PQ (Installation Qualification/Operational Qualification and Process Qualification) methodologies for equipment, tooling, and processes.
* Proactively follow and support departmental policies and procedures when performing standard work.
* Recommend, evaluate, and validate new materials in support of cost savings, alternates, and new product development.
* Coordinate tooling repairs, modifications, refurbishment, and procurement.
* Specify, procure, and implement new equipment.
* Support R&D and Operations continuous improvement/cost savings projects.
* Establish and maintain manufacturing procedures and quality plans.
* Perform visual inspections, recommend and perform approved mold modifications and/or repairs.
* Conduct meetings, document meeting minutes, and prepare technical and status reports as required for internal distribution and external communication.
* Assist in the training of mold maintenance personnel on current and new departmental processes and procedures to perform standard work for maintenance activities such as mold reconfiguration, replacement/repair of defective, worn or damaged mold components.
* Work cooperatively with all departments to resolve complex mold issues.
* Perform all job duties in a safe manner and obey all safety policies and procedures
* Perform all job duties consistent with the Code of Ethics and the 4-I Values
* Perform all job duties within ISO standards, regulatory and statutory requirements
* Perform other duties and cross training as assigned

How will you get here?

Education/ Experience

* BS Degree in Mechanical, Chemical or Plastics Engineering with 5 years of practical experience in a manufacturing environment or equivalent industry experience
* Minimum of 1 year injection molding process development experience.
* Hands-on experience with setup, operation, and troubleshooting/optimization of injection molding machines and processes.
* Experience with injection molding of life science, medical devices or laboratory products highly preferred.
* Process validation knowledge is preferred.
* Experience with scientific molding principles, and injection molding process optimization.
* Experience in mold and process IOPQ (Installation, Operational and Process Qualification) and product verification and validation preferred.
* Demonstrated ability to apply problem solving methodology to identify root cause and implement solutions.
* Experience with Good Manufacturing Practices (GMP), ISO standards, Lean manufacturing concepts and familiarization of FDA regulations desired.
* ISO 9001 familiarity and ISO 13485 preferred.
* Understanding of mechanical drawings, solid models and mold flow comprehension.
* Proficiency in SolidWorks is a plus.
* Strong organizational skills and ability to prepare and write reports and correspondence.
* Ability to handle multiple tasks and projects, and work effectively with other departments.
* Strong computer skills (e.g., Word, Excel, PowerPoint, and statistical software).
* Strong communication and interpersonal skills to interact and communicate with individuals in other departments at all levels of the organization.
* Excellent documentation and organizational skills
* Creative, innovative and critical thinking
* Analytical nature, responds positively to challenges and a problem solver
* Responsive, results oriented and task driven
* Seeks out collaboration opportunities
* Effective oral, written communication and presentation skills
* Willing to travel domestically and internationally approximately 10%

Our global team of more than 75,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon. For more information, please visit www.thermofisher.com.