• Lead Console Manufacturing operations ensuring adequate staffing, training and adherence to workmanship standards in a regulated medical device environment.
• Establish and enforce manufacturing controls to ensure strict procedural compliance, prevent non-conformances and maintain accurate, timely Device History Records (DHR’s).
• Plan and execute manufacturing builds to achieve monthly labor utilization and production targets.
• Supervise and develop a team of electronic equipment assemblers and technicians including task prioritization, training, qualification and performance management.
• Own and drive Non-Conformance (NCR) and CAPA processes end-to-end including investigation, root cause analysis, cross-functional action planning and timely closure.
• Troubleshoot returned goods and field failures including failure analysis, repair/rework definition, execution, verification testing and compliant documentation.
• Own electronics test strategy for production and service including:
  • Defining test       requirements and acceptance criteria
  • Developing and       maintaining test procedures
  • Selecting and       qualifying test equipment and fixtures
  • Analyzing       failures and ensuring traceable test records
• Lead equipment and process validation (IQ/OQ/PQ) activities ensuring compliance with regulatory and quality requirements.
• Manage product scale-up and design transfer from R&D to Manufacturing ensuring readiness for production.
• Provide Design for Manufacturability (DFM) input during product development including development of test methods and testbeds.
• Develop and maintain manufacturing documentation (BOMs, routers, work instructions, rework processes).
• Own supplier and component changes to support manufacturing continuity including:
  • Identification of       alternate suppliers/components
  • Technical       assessment and risk evaluation
  • Qualification       planning and execution
  • Change control       and documentation approvals
• Collaborate cross-functionally with R&D, Quality, Supply Chain and Finance to achieve departmental and organizational objectives.
• Drive continuous improvement initiatives focused on Quality, productivity, efficiency and cost reduction.
• Analyze and report manufacturing performance using metrics such as control charts, process capability, reliability, histograms and Pareto analysis.
• Investigate production issues and implement corrective and preventive solutions.

EXPERIENCE/SKILL REQUIREMENTS: 

• Minimum of 7 years of experience in medical device manufacturing engineering or another regulated industry.
• Demonstrated ownership of complex, cross-functional initiatives at a senior engineer level.
• Experience manufacturing capital equipment (medical device preferred).
• Experience in:
  • Electronics test       development and sustainment (test plans, procedures, fixtures, equipment       qualification)
  • Failure analysis       and troubleshooting
  • Test data       traceability and documentation compliance
• Experience leading supplier/component changes including:
  • Risk-based       qualification approaches
  • Verification and       validation impact assessment
  • Supplier       evaluation and approval
  • Implementation       via formal change control
• Strong knowledge of FDA Medical Device Regulations (21 CFR Part 820), ISO 13485 and  
• ISO 60601.
• Six Sigma and IPC certifications are a plus.

EDUCATIONAL REQUIREMENTS: 

Bachelor’s degree in electrical, mechanical, plastics, biomedical or related engineering field, or equivalent combination