Position Overview
Wallace Myers International is seeking a highly skilled and experienced Operations Engineer II to oversee and optimize manufacturing processes for medical devices.
Key Responsibilities:
* Lead the design, implementation, and continuous improvement of manufacturing processes for our 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.
* Evaluate and ensure all manufacturing activities are conducted in compliance with our 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:
1. Bachelor's degree in engineering or a related technical field.
2. Minimum of 3 years of experience in Operations engineering within the medical device industry.
3. Strong understanding of basic engineering principles.
4. Strong understanding of design control principles and regulations, including FDA QSR (21 CFR 820) and ISO 13485.
5. Experience with risk management methodologies, such as ISO 14971, and application to medical device development.
6. Proficiency in process validation techniques, including protocol development, execution, and documentation.
7. Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams.
8. Detail-oriented with strong analytical and problem-solving abilities.
9. Ability to work independently and manage multiple tasks simultaneously in a fast-paced, dynamic environment.
10. Ability to communicate clearly, accurately, and directly, both verbally and in writing, to a widely varied audience.