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Job Description
Senior Operations Engineer sought for early-stage medical device start-up focused on vascular disease treatment, requiring expertise in manufacturing process optimization and quality control.
We are recruiting for a key role in bringing significant advancements in the field to the next phase of development.
Key Responsibilities
- Process Design and Optimization: Lead the design, implementation, and optimization of manufacturing processes, including product assembly, testing, and packaging.
- Quality and Compliance: Ensure all manufacturing activities comply with the company's quality system and policies, including detailed documentation.
- Continuous Improvement: Drive initiatives to optimize production yield, cycle time, and resource utilization.
- Technical Support and Equipment Management: Provide technical support to the manufacturing line, manage equipment specification, procurement, calibration, and maintenance.
- External Representation and Supplier Liaison: Represent the company during interactions with suppliers and external partners.
Requirements
- Education: Bachelor's degree in engineering or a related technical field.
- Experience: Minimum of 5 years of experience in operations engineering within the medical device industry, preferably with neuro-interventional devices.
- Skills: Strong understanding of engineering principles and design control regulations, including FDA QSR (21 CFR 820) and ISO 13485.
- Additional Requirements: Experience with risk management methodologies, process validation techniques, and excellent communication and interpersonal skills.
The role offers excellent career progression opportunities and a well-compensated package.