Job Title: Operations Engineer
1. Oversee and optimize manufacturing processes for neuro medical devices.
2. Collaborate with cross-functional team members to ensure efficient production of high-quality products.
3. Lead the design, implementation, and continuous improvement of manufacturing processes.
4. Provide hands-on technical support to the manufacturing line.
5. Proactively monitor line performance, efficiency, and output.
6. Ensure all manufacturing activities are conducted in compliance with regulatory requirements.
7. Identify and implement efficiency enhancements to streamline manufacturing workflows.
8. Support the introduction of new product lines by establishing robust manufacturing processes.
9. Plan, execute, and document process validation activities.
10. Participate in process risk assessments and contribute to mitigation strategies.
11. Lead and support continuous improvement initiatives focused on optimizing product yield and resource utilization.
12. Collaborate cross-functionally with R&D, Quality Assurance, and Regulatory Affairs to ensure compliance.
13. Maintain detailed process documentation including work instructions and inspection procedures.
14. Manage equipment lifecycle activities, including specification, procurement, installation, calibration, and preventive maintenance.
15. Represent the company during external engagements showcasing manufacturing capabilities and quality practices.
16. Coordinate with suppliers regarding delivery schedules, quality concerns, and continuous improvement opportunities.
Requirements:
- Bachelor's degree in engineering or a related technical field.
- Minimum of 3 years of experience in Operations engineering within the medical device industry.
- Strong understanding of basic engineering principles.
Benefits:
- Competitive salary.
- Share options.
- Excellent opportunity to develop your experience and career in an exciting start-up helping develop a product from its very early stages.
Overview:
This role plays a key part in overseeing and optimizing our manufacturing processes for neuro medical devices. The individual will collaborate closely with cross-functional team members to ensure the efficient production of high-quality products that meet regulatory standards and exceed customer expectations.
Responsibilities:
17. Manufacturing Process Development and Improvement: Develop, implement, and continuously improve manufacturing processes for neuro medical devices.
18. Technical Support and Collaboration: Provide hands-on technical support to the manufacturing line, ensuring smooth day-to-day operations and swift resolution of issues.
19. Performance Monitoring and Efficiency Enhancement: Proactively monitor line performance, efficiency, and output, using data-driven insights to drive improvements.
20. Quality Management and Compliance: Ensure all manufacturing activities are conducted in compliance with regulatory requirements and internal policies.
21. New Product Line Introduction: Support the introduction of new product lines by establishing robust manufacturing processes, tooling, and fixtures.
22. Process Validation and Risk Assessment: Plan, execute, and document process validation activities and participate in process risk assessments to ensure robust manufacturing operations.
23. Continuous Improvement Initiatives: Lead and support continuous improvement initiatives focused on optimizing product yield and resource utilization.
24. Interdepartmental Collaboration: Collaborate cross-functionally with R&D, Quality Assurance, and Regulatory Affairs to ensure compliance with industry regulations and internal standards.
25. Documentation and Maintenance: Maintain detailed process documentation including work instructions and inspection procedures, and manage equipment lifecycle activities.
26. External Representation: Represent the company during external engagements showcasing manufacturing capabilities and quality practices.
27. Supplier Coordination: Coordinate with suppliers regarding delivery schedules, quality concerns, and continuous improvement opportunities.
Key Qualifications:
- Bachelor's degree in engineering or a related technical field.
- Minimum of 3 years of experience in Operations engineering within the medical device industry.
- Strong understanding of basic engineering principles.
What We Offer:
- Competitive salary.
- Share options.
- Excellent opportunity to develop your experience and career in an exciting start-up helping develop a product from its very early stages.