Position Overview

Start-up medical device company seeking a highly skilled and experienced Operations Engineer II. The successful candidate will play a key role in overseeing and optimizing manufacturing processes' for medical devices. This 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.

Key Responsibilities

• Lead the design, implementation, and continuous improvement of manufacturing processes for the company's flagship device, encompassing product assembly, testing, and packaging.
• Provide hands-on technical support to the manufacturing line, ensuring smooth day-to-day operations and swift resolution of issues.
• Proactively monitor line performance, efficiency, and output, using data-driven insights to drive improvements.
• Ensure all manufacturing activities are conducted in compliance with the company's Quality Management System (QMS) and applicable policies, including accurate documentation and comprehensive reporting.
• Identify and implement efficiency enhancements to streamline manufacturing workflows and reduce waste.
• Support the introduction of new product lines by establishing robust manufacturing processes, tooling, and fixtures.
• Plan, execute, and document process validation activities in alignment with regulatory and quality system requirements.
• Participate in process risk assessments and contribute to mitigation strategies to ensure robust manufacturing operations.
• Lead and support continuous improvement initiatives focused on optimizing product yield, reducing cycle time, and maximizing resource utilization.
• Collaborate cross-functionally with R&D, Quality Assurance, and Regulatory Affairs to ensure compliance with industry regulations and internal standards.
• Develop, review, and maintain detailed process documentation including work instructions, inspection procedures, and batch records to ensure clarity, traceability, and compliance.
• Maintain full traceability of finished goods in accordance with regulatory and internal requirements.
• Manage equipment lifecycle activities, including specification, procurement, installation calibration, and preventive maintenance.
• Represent the company during external engagements such as physician line tours, showcasing manufacturing capabilities and quality practices.
• 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.
• Strong understanding of design control principles and regulations, including FDA QSR (21 CFR 820) and ISO 13485
• Experience with risk management methodologies, such as ISO 14971, and application to medical device development.
• 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, dynamic environment.
• Ability to communicate clearly, accurately, and directly, both verbally and in writing, to a widely varied audience

At Wallace Myers International Recruitment Agency we specialise in sourcing professionals for key industries and services. See our website for more details.

Privacy Policy: By applying for this role you are agreeing that your details will be stored in our database and may be considered for similar future positions. For more info see wallacemyers.ie/privacy-policy