Daily Responsibilities:

• Lead and mentor Quality Engineers and Technicians.
• Oversee Quality Transfer and Design Control to manufacturing making sure process is scalable
• Monitor field issues of product and resolve with through collaboration with suppliers
• Ensure compliance with regulations and industry standards.
• Oversee daily quality activities and maintain budget.
• Support manufacturing and operations, both internally and with external vendors.
• Drive process improvements and participate in supplier quality activities.
• Manage design control, risk management, and compliance for sustaining projects.
• Conduct hardware and software verification and validation.
• Audit Design History Files (DHFs) for compliance.
• Investigate and document results for returned devices and complaints.
• Maintain the Servicing Program and support distribution quality activities.
• Analyze quality metrics and initiate Document Change Orders (DCOs).
• Participate in audits and support regulatory submissions.

Qualifications:

• Education: Bachelor’s in Electrical/Software Engineering (Master’s preferred).
• Experience: 10+ years in Hardware and Embedded Software Design, with 8+ years in the Medical Device industry.
• Technical Skills:
• Analog and Digital Circuit Design, PCB Layout, and prototype development.
• Embedded systems, version control, issue tracking, and control electronics for medical devices.
• Management: 2+ years managing others or equivalent experience.
• Regulations: Knowledge of ISO 13485, ISO 14971, IEC 62304, IEC 60601, 21 CFR Part 820, MDD 93/42/EEC, EU MDR, and MDSAP.
• Statistical Analysis: Proficient with Minitab and statistical techniques.
• Preferred Experience: Class III medical devices and electromechanical products, complaint investigations.