Controls Engineer
Position Summary
We are seeking a talented and motivated Controls Engineer to join our dynamic team developing innovative medical devices. The Controls Engineer will be responsible for designing, developing, and maintaining control systems that ensure the safety, reliability, and performance of our products.
Key Responsibilities
- Design, develop, and implement control systems for medical devices, including embedded software, PLCs, and HMIs.
- Develop and execute test protocols to validate control system performance and compliance with regulatory standards (FDA, ISO 13485, IEC 60601, etc.).
- Collaborate with mechanical, electrical, and software engineers to integrate control solutions into new and existing products.
- Troubleshoot and resolve control system issues during development, manufacturing, and post-market support.
- Generate and maintain technical documentation, including requirements, design specifications, risk analyses, and validation reports.
- Participate in design reviews, risk assessments, and failure mode analyses.
- Support regulatory submissions by providing technical input and documentation as needed.
- Stay current with industry trends, standards, and emerging technologies in controls engineering and medical devices.
Qualifications
- Bachelor of Science in Mechatronics, Electrical, Electronics Engineering or related field.
- Experience in controls engineering, preferably in the medical device or regulated industry.
- Proficiency with control system design tools (e.g., MATLAB/Simulink, LabVIEW, PLC programming).
- Experience with embedded systems, sensors, actuators, and real-time control algorithms.
- Familiarity with medical device regulations and standards (FDA, ISO 13485, IEC 60601) is a plus.
- Strong problem-solving skills and attention to detail.
- Excellent communication and teamwork abilities.
FAQs
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