Work Schedule

First Shift (Days)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office

Job Description

Position Summary

Responsible for strategically leading the Engineering function in a pipette micromolding, injection molding, blow molding, and assembly plant, with focus on capital projects, capacity expansions, plant sustainability, engineering changes and releases, as well as product and process validations and revalidations.

This role ensures that engineering solutions support business objectives, regulatory compliance, and customer requirements, working in coordination with the Tool Room (molds) area, without direct operational responsibility over maintenance or Tool Room.

Job Duties and General Responsibilities

Engineering Strategy and Leadership

• Define and execute engineering strategy aligned with site and division objectives
• Lead, mentor, and develop a high-performing engineering team
• Promote a culture of continuous improvement, accountability, and compliance
• Manage Engineering budget, including CAPEX planning and prioritization

Projects, Expansions, and Sustainability

• Lead capital projects (new molding technologies, automation, capacity expansion)
• Drive sustainability initiatives (energy efficiency, waste reduction, resource optimization)
• Coordinate layout planning, process flows, and line balancing

Engineering Changes and Releases

• Manage engineering changes (ECR/ECO)
• Evaluate impact on quality, validation, cost, and capacity
• Approve and release changes per quality and regulatory requirements
• Ensure documentation is accurate, current, and controlled

Validations and Regulatory Compliance

• Own the Validation Master Plan
• Lead IQ/OQ/PQ, revalidations, and process qualifications
• Ensure compliance with ISO 13485, ISO 9001, and applicable regulatory standards

New Products and Customer Requirements

• Lead New Product Introduction (NPI) activities
• Ensure effective design transfer into manufacturing
• Interpret and implement customer specifications
• Collaborate cross-functionally with Quality, Production, Supply Chain, and Maintenance

Interaction with Molding and Tool Room

• Optimize molding processes, including micromolding, injection molding, and blow molding, focusing on precision, repeatability, and efficiency
• Collaborate with Tool Room on mold design, maintenance strategies, and continuous improvement
• Act as a technical liaison between engineering and tooling functions

Continuous Improvement and Methodologies

• Promote Lean / PPI methodologies and structured problem-solving
• Ensure safety, ergonomics, and environmental compliance

People Management and Culture

• Ensure adherence to Code of Conduct and company policies
• Conduct performance evaluations (PMD)
• Develop succession plans and foster talent growth

Minimum Requirements

Education

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

Experience

• Minimum of 10 years of experience leading and managing engineering organizations within molding manufacturing environments
• Recognized expertise in molding operations for medical devices and/or life sciences components, ensuring compliance with regulatory and quality standards
• Hands-on knowledge of micro-molding processes, including challenges related to precision, tooling, and process control
• Proven track record leading **capital projects, capacity expansions, and New Product Introduction (NPI)**in highly regulated environments (e.g., ISO 13485, FDA)
• Demonstrated ability to drive process optimization, scalability, and operational excellence in molding operations

Languages

• Advanced English

Additional Certifications (Preferred)

• PMP
• Six Sigma (Green/Black Belt)
• Lean Manufacturing
• Certified Quality Engineer (CQE)

Specialized Skills

• Strong expertise in precision molding technologies, particularly micromolding, with solid fundamentals in injection and/or blow molding
• Validation methodologies (IQ/OQ/PQ)
• Experience in regulated environments (ISO 13485, FDA or similar)
• Project management and CAPEX planning
• Engineering change management (ECR/ECO)
• Data analysis and structured problem solving (Lean, Six Sigma)
• Cross-functional leadership and stakeholder management
• Strategic thinking and decision-making