Engineer II, Manufacturing Engineering

ThermoFisher Scientific; Tijuana; On-site; MXN 420,000 - 540,000; Full time

Job summary

Thermo Fisher Scientific in Tijuana, Mexico, seeks a Manufacturing Engineer II to optimize production processes and equipment. You will manage cross-functional projects, drive process improvements, and ensure high-quality manufacturing operations in a regulated setting.

The role emphasizes coordinating mold qualification/validation, applying GMP/ISO13485 standards, and delivering technical documentation. Strong English communication and Lean/Six Sigma experience are valued.

Qualifications

• Bachelor's degree in Manufacturing/Mechanical/Industrial engineering or related field.
• 2+ years in Manufacturing Engineering in regulated environment (medical devices preferred).
• Experience with plastic injection molding, molds, tooling, and thermoplastics.
• Experience coordinating mold qualification and validation activities (IQ/OQ/PQ).
• Strong technical writing for engineering docs and validation reports.
• Proven ability to lead cross-functional manufacturing projects.
• Knowledge of GMP, ISO 13485, and FDA requirements.
• Statistical analysis for manufacturing (Cp/Cpk/Pp/Ppk, MSA); Minitab preferred.
• Ability to interpret drawings, CTQs, specs, and mold docs.
• Experience with Lean/Six Sigma or other CI methodologies.
• Good written and verbal English communication.

Responsibilities

• Manage technical projects and process improvements in manufacturing.
• Support manufacturing operations and equipment optimization.
• Collaborate across functions (Quality, R&D, Regulatory) to ensure compliance.
• Coordinate mold qualification/validation activities.
• Provide training and support to technical staff.
• Develop project plans, track actions, and manage timelines.

Skills

Manufacturing engineering

Regulated manufacturing

Injection molding

Process validation

Technical writing

Cross-functional leadership

Quality systems (GMP/ISO 13485/FDA)

Statistical analysis (Cp/Cpk/MSA)

Reading drawings & specs

Lean Six Sigma

English communication

Education

Bachelor’s Degree in Manufacturing, Mechanical, Industrial Engineering, or related technical field

Tools

Minitab

Injection molding equipment

Job description

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

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:

• 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, escaland 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.

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.