Job Description
Injection Mould Solutions Manager
Position Summary
Prior PLM Medical are seeking an experienced and commercially focused Injection Mould Solutions Manager to lead our Injection Mould Solutions Division within a highly regulated medical device manufacturing environment.
The successful candidate will have extensive experience in precision injection moulding, tool design, validation, process development, and customer project management. They will be responsible for leading a multidisciplinary team, delivering technical excellence, ensuring regulatory compliance, driving operational performance, and supporting business growth.
This role requires a strong leader with significant experience in medical device manufacturing, ISO 13485 quality systems, FDA regulations, and the successful delivery of complex tooling and manufacturing solutions.
Key Responsibilities
Leadership & Strategy
- Lead and develop the Injection Mould Solutions Division.
- Develop and implement strategic plans aligned with company objectives.
- Manage departmental budgets and capital expenditure.
- Drive continuous improvement initiatives across the business.
- Build a high-performance culture focused on quality, customer satisfaction and operational excellence.
- Mentor and develop engineering, tooling and manufacturing teams.
Technical Leadership
- Provide technical leadership for all injection moulding activities.
- Oversee tooling design, manufacture, validation and maintenance.
- Support Design for Manufacture (DFM) reviews.
- Lead process development and optimisation.
- Oversee mould trials, process capability studies and validation activities.
- Ensure robust scientific moulding principles are implemented.
- Support new technology implementation and automation projects.
Medical Device Compliance
Ensure compliance with:
- ISO 13485
- EU Medical Device Regulation (MDR)
- GMP requirements
- Risk Management (ISO 14971)
- Validation requirements including:
- IQ
- OQ
- PQ
- Change Control
- CAPA
- Non-conformance Management
- Internal and External Audits
Operational Management
- Manage daily operations of the Injection Mould Solutions Division.
- Monitor departmental KPIs.
- Improve productivity, efficiency and profitability.
- Ensure projects are delivered on time and within budget.
- Manage supplier relationships.
- Support capacity planning.
- Develop resource plans.
- Monitor manufacturing performance.
- Identify operational risks and implement mitigation plans.
Customer Management
- Act as senior technical contact for customers.
- Attend customer meetings.
- Provide technical solutions.
- Support quotation development.
- Manage customer expectations.
- Resolve technical issues.
- Support customer audits.
- Build long-term customer relationships.
Project Management
Lead projects from concept through production including:
- Tool Design
- DFM Reviews
- Tool Manufacture
- Validation
- Process Development
- PPAP (where applicable)
- Customer Approval
- Production Launch
Ensure projects achieve:
- Quality
- Cost
- Delivery
- Regulatory Compliance
Financial Responsibility
- Prepare annual budgets.
- Monitor departmental profitability.
- Control project costs.
- Improve gross margins.
- Identify cost-saving opportunities.
- Support sales growth.
- Review capital investment proposals.
Essential Qualifications
- Degree in Mechanical Engineering, Polymer Engineering, Manufacturing Engineering or related discipline.
- Minimum 10–15 years' experience in medical device manufacturing.
- Minimum 5 years in a senior management role.
- Extensive experience in precision injection moulding.
- Strong understanding of mould tooling technologies.
- Proven experience managing multidisciplinary engineering teams.
Essential Experience
- Medical Device Manufacturing
- Precision Injection Moulding
- Tool Design
- Scientific Moulding
- Validation
- Automation
- Lean Manufacturing
- Continuous Improvement
- Project Management
- Customer Relationship Management
- Budget Management
- Team Leadership
- Supplier Management
- Risk Management
Technical Knowledge
Strong knowledge of:
- ISO 13485
- FDA Regulations
- EU MDR
- GMP
- Validation Protocols
- Process Validation
- IQ/OQ/PQ
- Root Cause Analysis
- FMEA
- DOE
- Statistical Process Control (SPC)
- Minitab
- CAD Systems
- ERP Systems
- Microsoft Office
Leadership Competencies
The successful candidate will demonstrate:
- Exceptional leadership skills
- Strategic thinking
- Commercial awareness
- Strong decision-making ability
- Excellent communication skills
- Customer-focused approach
- High level of accountability
- Ability to influence across all levels
- Excellent organisational skills
- Strong analytical ability
- Commitment to quality and continuous improvement
Key Performance Indicators (KPIs)
The Injection Mould Solutions Manager will be measured on:
- Customer satisfaction
- On-time project delivery
- Project profitability
- Departmental productivity
- Quality performance
- Scrap reduction
- OEE improvement
- Validation success rate
- Employee engagement
- Budget performance
- Continuous improvement savings
- New business support
- Audit performance
- CAPA effectiveness
- Health & Safety performance
Personal Attributes
The ideal candidate will be:
- Highly motivated
- Results-driven
- Innovative
- Commercially focused
- Detail-oriented
- Collaborative
- Customer-focused
- Adaptable
- Resilient under pressure
- Passionate about delivering excellence
Pay: €50,000.00-€90,000.00 per year
Benefits:
- Company pension
- On-site parking
Work Location: In person
