Work Schedule

First Shift (Days)

Environmental Conditions

Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed

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:

Responsible for strategically leading the Engineering function at a plant for pipette molding, blow molding, and assembly, with a focus on capital projects, capacity expansions, plant sustainability, engineering changes and releases, as well as product and process validations and revalidations. The role ensures that engineering solutions support business objectives, regulatory compliance, and customer requirements, working in coordination with the Tool Room (molds), with no direct operational responsibility over Maintenance or the Tool Room.

Main Functions and Responsibilities

• Engineering Strategy and Leadership

• Define and execute the engineering strategy aligned with site and division objectives.

• Lead and develop the engineering team, promoting a high-performance, continuous improvement, and compliance culture.

• Manage the Engineering budget, including planning and CAPEX justification for projects and expansions.

• Projects, Expansions, and Sustainability

• Lead capital projects related to new molding lines, capacity expansion, automation, and process optimization.

• Ensure projects consider sustainability principles, energy efficiency, waste reduction, and responsible resource use.

• Coordinate layout planning, process flows, and line balancing with Production and Pipette Molding.

• Engineering Changes and Releases

• Ensure proper management of engineering changes (ECR/ECO), assessing impact on quality, validation, cost, and capacity.

• Approve and release engineering changes per quality system procedures and regulatory requirements.

• Ensure technical and process documentation is updated, controlled, and aligned with current production status.

• Validations and Regulatory Compliance

• Own the development, execution, and maintenance of the Validation Master Plan.

• Lead validations of new products, processes, and equipment (IQ/OQ/PQ), as well as periodic revalidations.

• Ensure compliance with ISO 13485, ISO 9001, and other applicable medical device regulatory requirements.

• New Products and Customer Requirements

• Lead New Product Introduction (NPI), ensuring robust transfer from design to manufacturing.

• Ensure customer specifications are correctly interpreted, documented, and implemented in molding and assembly processes.

• Coordinate with Quality, Production, Supply Chain, and Maintenance to guarantee successful, stable launches.

• Interaction with Pipette Molding and Tool Room

• Work closely with the Pipette Molding area to optimize process parameters, capacity, efficiency, and quality.

• Collaborate with the Tool Room on mold design, engineering changes, new developments, and improvements, acting as a technical and strategic liaison, with no direct operational responsibility.

• Continuous Improvement and Methodologies

• Promote Lean/PPI methodologies for structured problem-solving and continuous improvement.

• Ensure engineering processes consider safety, ergonomics, and environmental compliance.

• People Management and Culture

• Ensure compliance with the Code of Conduct and Ethics, as well as corporate policies.

• Execute performance evaluations under the PMD process and develop succession and talent growth plans.

Job Requirements

• Education

• Bachelor’s degree in Engineering (Industrial, Mechanical, Mechatronics, Manufacturing, or related).

• Master’s degree in Engineering or Administration (preferred).

• Experience

• Minimum 10 years of experience in Manufacturing Engineering, preferably in injection molding processes.

• Solid experience leading capital projects, capacity expansions, and NPI in regulated environments.

• Languages

• Advanced English (reading, writing, and verbal communication).

• Key Knowledge and Competencies

• Injection molding processes (preferred experience in medical devices or precision plastics).

• Project management (CAPEX, schedules, risks).

• IQ/OQ/PQ validations and ISO 13485 quality systems.

• Engineering change management and document control.

• Leadership of multidisciplinary teams.

• Analytical approach, decision-making, and results orientation.