Senior Operations Engineer
We are recruiting for a key role in an early-stage medical device start-up focused on developing innovative solutions for Vascular Disease treatment. The Senior Operations Engineer will play a crucial part in driving the company's next phase of development by overseeing and optimizing manufacturing processes for neuromedical devices.
Key Responsibilities:
* Process Design and Optimization: Lead the design, implementation, and optimization of manufacturing processes, including product assembly, testing, and packaging. Identify opportunities for improved efficiency and establish new processes for new product lines.
* Quality and Compliance: Ensure all manufacturing activities comply with quality system and policies. Collaborate with R&D, Quality Assurance, and Regulatory Affairs teams to maintain regulatory requirements and industry standards.
* Continuous Improvement: Drive initiatives to optimize production yield, cycle time, and resource utilization. Participate in risk assessments and mitigation activities related to manufacturing processes.
* Technical Support and Equipment Management: Provide technical support to the manufacturing line, manage equipment specification, procurement, calibration, and maintenance, and maintain traceability of finished products.
* External Representation and Supplier Liaison: Represent the company during physician line tours and liaise with suppliers regarding delivery schedules and quality issues.
Requirements:
* Bachelor's degree in engineering or a related technical field.
* Minimum 5 years of experience in operations engineering within the medical device industry, preferably with neuro-interventional devices.
* Strong understanding of engineering principles and design control regulations.
* Experience with risk management methodologies.
* Proficiency in process validation techniques.
* Excellent communication and interpersonal skills.
* Detail-oriented with strong analytical and problem-solving abilities.
* Ability to work independently and manage multiple tasks simultaneously.
* Clear and accurate communication skills.