Our client, an advanced medical device start up are looking to hire a skilled Operations Engineer II to optimize manufacturing processes for their neuro medical devices. The successful applicant willlead process design and improvement, ensure regulatory compliance, and collaborate with cross-functional teams to drive efficiency and product quality.
Key Responsibilities:
Process Optimization: Design, implement, and improve manufacturing processes for assembly, testing, and packaging.
Technical Support: Provide hands-on support to manufacturing operations, ensuring smooth day-to-day function.
Performance Monitoring: Use data to identify and implement improvements in line performance and efficiency.
Compliance & Documentation: Ensure adherence to QMS and regulatory standards, maintaining accurate records.
Efficiency & Waste Reduction: Drive initiatives to streamline workflows and reduce waste.
New Product Lines: Establish robust manufacturing processes for new products.
Process Validation: Plan and execute validation activities per regulatory requirements.
Risk Management: Participate in risk assessments and mitigation strategies.
Continuous Improvement: Lead initiatives to enhance yield, reduce cycle times, and optimize resources.
Cross-Functional Collaboration: Work with R&D, QA, and Regulatory Affairs to ensure compliance.
Equipment Management: Oversee equipment lifecycle from specification to maintenance.
Supplier Coordination: Work with suppliers on quality concerns, schedules, and improvement opportunities.
Requirements:
Bachelor’s degree in Engineering or related field.
Minimum 3 years in operations engineering, preferably with neuro devices.
Strong knowledge of FDA QSR (21 CFR 820), ISO 13485, risk management (ISO 14971), and process validation.
Excellent verbal and written communication skills.
Strong analytical and troubleshooting abilities in a fast-paced environment.
For a confidential discussion, a more detailed job spec and more information on the role, please contact Amy Newell.
amy.newell@collinsmcnicholas.ie
091-706718