The Manufacturing Electrical/Software Engineer with provide expertise in electromechanical medical device manufacturing including hardware and software integration and supporting the manufacturing of FDA- and ISO-compliant medical devices. This role involves troubleshooting electrical and software-related production issues, optimizing manufacturing processes, and ensuring the successful delivery of high-quality medical devices.

Key Responsibilities:

Manufacturing Support & Process Optimization

Develop and optimize manufacturing processes for electromechanical medical devices.
Write or revise Manufacturing Work, Inspection and Test Instructions as needed.
Troubleshoot electrical and software-related production issues to minimize downtime.
Collaborate with cross-functional teams (Mechanical, Quality, Electrical and Software Engineering) to ensure seamless hardware-software integration.
Work with suppliers and contract manufacturers to resolve component and assembly issues.

Electrical & Software Integration

Support hardware-software interactions, ensuring smooth communication between firmware, embedded systems, and electromechanical components.
Assist in software installation, validation, and troubleshooting in the manufacturing process.
Validate and test electrical and software functions to ensure compliance with design specifications.
Develop and maintain test fixtures, automated test scripts, and diagnostic tools for production testing.

Regulatory Compliance & Quality Assurance

Ensure manufacturing processes adhere to FDA (21 CFR Part 820), ISO 13485, and GMP requirements.
Participate in process validation (IQ, OQ, PQ) and risk assessments (ISO 14971).
Support CAPA investigations, root cause analysis, and implementation of corrective actions.
Document and maintain manufacturing procedures, work instructions, and validation reports.

Continuous Improvement & Lean Manufacturing

Identify and implement process improvements and efficiency enhancements.
Support the implementation of lean manufacturing, Six Sigma, and cost-reduction initiatives.
Analyze production data to optimize yield, reduce defects, and improve cycle times.

Qualifications & Skills:

Education: Bachelor’s or Master’s degree in Electrical Engineering, Software Engineering, Computer Engineering, or a related field.
Experience: Minimum 5 years in manufacturing of electromechanical medical devices.
Technical Skills:
Strong knowledge of embedded systems, PCB design, circuit debugging, and software-controlled hardware.
Experience with C/C++, Python, or other scripting languages for automation and testing.
Familiarity with firmware, real-time operating systems (RTOS), and communication protocols (UART, I2C, SPI, CAN, etc.).
Hands-on experience with diagnostics, troubleshooting, and root cause analysis of software-electrical issues.
Proficiency with electronic test equipment (oscilloscopes, multimeters, logic analyzers, etc.).
Experience developing and maintaining automated test systems for production.
Regulatory & Quality Knowledge:
Strong understanding of FDA regulations, ISO 13485, and risk management (ISO 14971).
Experience with design verification, process validation (IQ, OQ, PQ), and regulatory documentation.
Knowledge of cybersecurity and software validation requirements (FDA Software Guidance, IEC 62304) is a plus.
Soft Skills:
Excellent problem-solving and troubleshooting abilities.
Strong collaboration skills with cross-functional teams.
Ability to work in a fast-paced manufacturing environment with a focus on quality and efficiency.

Working Conditions:

This is a full-time, on-site position that requires active participation in daily operations on site at least 4/5 days of the week.
Occasional travel to suppliers may be required

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