Senior Operations Engineer
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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For a confidential discussion and more information on the role, please contact
davin.ferguson@collinsmcnicholas.ie
071-9140251