At a glanceSummarised by Seekless from the posting.
Must have17
Bachelor’s Degree in Manufacturing, Mechanical, Industrial Engineering, or related technical field.
2+ years of Manufacturing Engineering experience in a regulated manufacturing environment, preferably medical devices.
Working knowledge of plastic injection molding processes, molds, tooling, thermoplastic materials, and injection molding equipment.
Experience coordinating injection mold qualification and validation activities, including Engineering Studies, IQ/OQ/PQ, validation protocols, reports, and supporting documentation.
Strong technical writing skills with demonstrated experience preparing, reviewing, and maintaining engineering and validation documentation.
Experience leading cross-functional manufacturing projects involving Process Engineering, Quality, Tool Room, Metrology, Operations, R&D/Product Engineering, and Regulatory, as applicable.
Ability to develop project plans, coordinate activities, track actions, manage timelines, escalate risks, and drive projects through completion.
Experience with change control, deviations, risk assessments, PFMEA, CAPA, and controlled documentation within a regulated quality system.
Working knowledge of GMP, ISO 13485, FDA requirements, and applicable internal quality systems.
Proficiency in statistical analysis for manufacturing and validation activities, including process capability (Cp/Cpk/Pp/Ppk), normality, confidence/reliability, sample-size rationale, MSA, and data trending.
Ability to interpret engineering drawings, product specifications, CTQs, dimensional reports, mold documentation, and manufacturing specifications.
Ability to review injection molding process-development and characterization results and determine whether sufficient objective evidence exists to support qualification/validation activities.
Experience coordinating dimensional, functional, and product testing required to support mold qualification and validation.
Strong written and verbal communication skills in English, including technical reports, protocols, meetings, and presentations.
Experience with Lean, Six Sigma, PPI, or other continuous-improvement methodologies.
Ability to support manufacturing troubleshooting, mold transfers, new-product introduction, capacity improvements, and process changes.
Experience training and supporting technical/manufacturing personnel.
Nice to have1
Minitab experience preferred.
Skills
Minitab
GMP
ISO 13485
PFMEA
CAPA
Lean
Six Sigma
PPI
Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc… allowed, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)
Job Description
About the company
As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.
DESCRIPTION:
Join our collaborative team at Thermo Fisher Scientific as a Manufacturing Engineer II, where you’ll contribute to excellence in production processes and equipment optimization. In this role, you’ll work across functions to ensure high-quality manufacturing operations while contributing to our mission of enabling customers to make the world healthier, cleaner, and safer. You’ll manage technical projects, implement process improvements, and provide essential support to manufacturing operations. This position offers opportunities for professional development and impact in an organization dedicated to scientific advancement.
Requirements
REQUIREMENTS:
Bachelor’s Degree in Manufacturing, Mechanical, Industrial Engineering, or related technical field.
•
2+ years of Manufacturing Engineering experience in a regulated manufacturing environment, preferably medical devices.
•
Working knowledge of plastic injection molding processes, molds, tooling, thermoplastic materials, and injection molding equipment.
•
Experience coordinating injection mold qualification and validation activities, including Engineering Studies, IQ/OQ/PQ, validation protocols, reports, and supporting documentation.
•
Strong technical writing skills with demonstrated experience preparing, reviewing, and maintaining engineering and validation documentation.
•
Experience leading cross-functional manufacturing projects involving Process Engineering, Quality, Tool Room, Metrology, Operations, R&D/Product Engineering, and Regulatory, as applicable.
•
Ability to develop project plans, coordinate activities, track actions, manage timelines, escalate risks, and drive projects through completion.
•
Experience with change control, deviations, risk assessments, PFMEA, CAPA, and controlled documentation within a regulated quality system.
•
Working knowledge of GMP, ISO 13485, FDA requirements, and applicable internal quality systems.
•
Proficiency in statistical analysis for manufacturing and validation activities, including process capability (Cp/Cpk/Pp/Ppk), normality, confidence/reliability, sample-size rationale, MSA, and data trending. Minitab experience preferred.
•
Ability to interpret engineering drawings, product specifications, CTQs, dimensional reports, mold documentation, and manufacturing specifications.
•
Ability to review injection molding process-development and characterization results and determine whether sufficient objective evidence exists to support qualification/validation activities.
•
Experience coordinating dimensional, functional, and product testing required to support mold qualification and validation.
•
Strong written and verbal communication skills in English, including technical reports, protocols, meetings, and presentations.
•
Experience with Lean, Six Sigma, PPI, or other continuous-improvement methodologies.
•
Ability to support manufacturing troubleshooting, mold transfers, new-product introduction, capacity improvements, and process changes.
•
Experience training and supporting technical/manufacturing personnel.