Job Description

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

Job Tags

Similar Jobs