Where You Come In
As a Senior Equipment Engineer, you will
Maintain and optimize automated manufacturing equipment to ensure peak performance and compliance with medical device standards.
Lead troubleshooting and root cause analysis for equipment-related issues to minimize downtime.
Support installation, setup, and qualification of new automated equipment and systems.
Perform on-site equipment buyoff and acceptance testing with vendors.
Participate in equipment design discussions to influence manufacturability and reliability.
Prepare, edit, and execute IQ (Installation Qualification) and OQ (Operational Qualification) protocols for new equipment.
Draft new IQ/OQ documentation and ensure compliance with regulatory standards.
Collaborate on automation, IoT integration, and SCADA system projects (e.g., Ignition) to enable smart manufacturing and real-time equipment monitoring.
Drive continuous improvement initiatives to enhance productivity, yield, and cost efficiency.
Ensure adherence to safety, environmental, and regulatory requirements (ISO 13485, FDA).
Work closely with cross-functional teams to implement automation solutions and best practices.
What Makes You Successful
Technical Expertise
Strong knowledge of automation systems, robotics, and PLC programming/software (Siemens, Allen-Bradley, or similar).
Hands-on experience with pneumatic systems and electrical troubleshooting.
Understanding of IoT technologies for equipment connectivity and data analytics.
Familiarity with SCADA systems (e.g., Ignition) for equipment monitoring and control.
Medical Manufacturing Knowledge: Understanding of GMP, ISO 13485, and FDA requirements.
Problem-Solving Skills: Ability to analyze complex equipment issues and implement effective solutions quickly.
Continuous Improvement Mindset: Familiarity with Lean, TPM (Total Productive Maintenance), or Six Sigma principles.
Collaboration: Excellent communication and teamwork skills to work across departments.
Adaptability: Thrive in a fast-paced, highly regulated environment with evolving technologies.
Qualifications
Bachelor’s degree in Mechanical, Electrical, Mechatronics, or related engineering field.
3–5 years of experience in equipment engineering within medical device or high-tech manufacturing.
Hands-on experience with automated equipment, preventive maintenance, and troubleshooting.
Experience in PLC programming/software, pneumatic systems, electrical circuits, IoT integration, SCADA systems (Ignition preferred), TPM, and IQ/OQ documentation and execution is highly preferred.
Additional Requirements
Travel: Occasional travel may be required for new project transfers from HQ, equipment buyoff, vendor support, or training (domestic and international).
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