The role entails ensuring the manufacturing process is efficient and meets agreed-upon Key Performance Indicators (KPIs) through continuous improvement efforts.
- Health & Safety: Ensure compliance with all Health, Safety, and Environmental regulations relevant to the manufacturing process.
- Quality: Implement engineering solutions to uphold Right First-Time principles, enhance yield, reduce complaints, and support Corrective and Preventive Action (CAPA) processes.
- Continuous Improvement: Take charge of the manufacturing process, collaborate with key stakeholders and operations teams to evaluate process capabilities, prioritize improvement opportunities, and implement Lean and six-sigma methodologies.
- Service: Foster a culture of Exceptional Customer Experience (ECE) for both internal and external customers by consistently meeting or surpassing project commitments.
- New Product Introduction: Assist in the introduction of new parts in coordination with the Prototyping / New Product Development (NPD) Group. Overall Equipment Performance (OEE) Management: Utilize Lean Manufacturing tools and techniques (e.g., Total Productive Maintenance) to optimize equipment performance.
- Preventative Maintenance: Ensure effectiveness of equipment preventative maintenance procedures and adherence to the preventative maintenance program.
- Introduction of New Equipment: Manage the introduction of new equipment including installation validation, process development, and validation.
- Quality and Technical Issue Resolution: Address quality and technical issues promptly to minimize impact on product supply to customers and support Business Unit Corrective and Preventive Actions (CAPAs), Non-conformances (NCs), Failure Mode and Effects Analyses (FMEAs), and audit preparation activities.
- Standard Operating Procedures (SOPs) Management: Develop and manage SOPs, manufacturing standards, and operations standard work in compliance with change control processes.
- Capital Expenditure (CAPEX) Management: Oversee CAPEX for new and replacement equipment, including researching state-of-the-art process technologies and evaluating their potential competitive advantages and cost benefits.
- Compliance: Maintain high-quality and compliance standards in accordance with Medical Devices manufacturing requirements.
- External Relationships: Manage relationships with key technology providers. Workload Management: Manage variable workload to meet operational requirements.
Candidate Desired Profiles:
Bachelor's degree in Polymer Technologies or equivalent.
Minimum of 3 years experience in a similar engineering role preferred.
Injection Moulding experience is essential.
Experience in the Medical Device industry is advantageous, but not required.
Proficient in Lean Manufacturing principles and statistics. Familiarity with Minitab software is desirable.
SolidWorks /AutoCAD skills are advantageous.
Demonstrates dynamism, motivation, flexibility, and a results-oriented approach to work.
Excellent communication, planning, and organizational skills. Knowledge of ISO and FDA compliance standards.
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