Thermo Fisher Scientific Sr Process Development Engineer - Injection Molding in Petaluma, California
When you join us at Thermo Fisher Scientific, you’ll be part of a smart, driven team that shares your passion for exploration and discovery. With revenues of $22 billion and the largest investment in R&D in the industry, we give our people the resources and opportunities to make significant contributions to the world.
The Sr. 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?
Your ideas will bring new products to life as you collaborate with other design engineers, process development engineers, product managers and project leaders to develop plastic products for life science, medical device, laboratory, diagnostic and consumer product markets. 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?
Detailed Process Development: Responsible for process development plans and equipment optimization activities. Use process analytical tools, DOE methods, risk assessment, plastic part and mold design practices.
Concept Process Design and Development: Responsible for completing Design for Manufacturing (DFM) reviews of new product designs, determine process feasibility and development options. Review process specifications and development plans with appropriate mold makers, contract manufacturers, prototyping services, equipment or other service suppliers.
Process Verification: Conduct FAT (Factory Authorized Test), IQ (Installation Qualification), OQ (Operational Qualification) and PQ (Process Qualification) for molds and/or equipment and molding processes. Coordinate measurement and dimensional studies. Document results with detailed technical reports.
Participate on cross-functional project teams to develop and verify manufacturing processes. Present development results at technical reviews. Communicate effectively within team and to engineering management on process development progress.
Equipment Selection: Select and specify primary and secondary plastic processing equipment. Develop project capital, product cost requirements and appropriations requests.
Perform all job duties within ISO standards, regulatory and statutory requirements
Drive Continuous Improvement initiatives and support all PPI and Lean projects
Perform other duties and cross training as assigned
How will you get here?
- BS Degree in Mechanical, Chemical or Plastics Engineering or equivalent industry experience with minimum 10 years injection molding process development experience.
Experience with injection molding of life science, medical devices or laboratory products required.
Experience with plastic design analysis tools, design of experiments (DOE), scientific molding practices, and mold design.
Experience with defining plastic resins, process equipment, and mold tooling technical specifications for quotations, procurement, and verification.
Experience in mold and process IOPQ (Installation, Operational and Process Qualification) and product verification and validation.
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.
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%
At Thermo Fisher Scientific, each one of our 70,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer.
If you are an individual with a disability who requires reasonable accommodation to complete any part of our application process, click here at https://jobs.thermofisher.com/page/show/eeo-affirmative-action-statement#accessibility for further assistance.
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.