We are recruiting for the key role of Senior Operations Engineer for an early-stage medical device start-up focused on developing innovative solutions for the treatment of Vascular Disease. This company is at the forefront of significant advancements in its field and the Senior Operations Engineer will play a key role in bringing them to the next phase of their development by overseeing and optimizing their manufacturing processes for neuromedical devices, ensuring efficient production of high-quality products that meet regulatory standards and exceed customer expectations.
Key Responsibilities
* Process Design and Optimization: Lead the design, implementation, and optimization of manufacturing processes, including product assembly, testing, and packaging. Identify and implement opportunities for improved efficiency and establish new processes for new product lines.
* Quality and Compliance: Ensure all manufacturing activities comply with the company’s quality system and policies, including detailed documentation. Collaborate with R&D, Quality Assurance, and Regulatory Affairs teams to maintain compliance with 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 all 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 of 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, including FDA QSR (21 CFR 820) and ISO 13485.
* Experience with risk management methodologies such as ISO 14971.
* Proficiency in process validation techniques, including protocol development, execution, and documentation.
* Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams.
* Detail-oriented with strong analytical and problem-solving abilities.
* Ability to work independently and manage multiple tasks simultaneously in a fast-paced environment.
* Clear and accurate communication skills, both verbal and written.
The role is very well compensated and offers excellent career progression opportunities.
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