Principal Electrical Engineer, Medical Devices

Job Title

Principal Electrical Engineer, Medical Devices

Requisition

JR000014540 Principal Electrical Engineer, Medical Devices (Open)

Location

Madison, WI

Additional Locations

Job Description Summary

Job Description

The Principal Electrical Engineer, Medical Devices provides critical product and technical expertise to the sustaining engineering team in the following areas to help achieve product realization and business goals for product quality, safety, efficacy, reliability, fulfillment, customer satisfaction, and cost.

Essential Functions:

• System-level design analysis and improvement

• Electrical/electronic and electromechanical design analysis and improvement

• Manufacturing, reliability and quality engineering

• Engagement with cross-functional teams to develop and improve nitric oxide delivery systems and related technology

• Develop and implement product design changes and projects to continuously improve safety, quality, reliability, fulfillment, customer satisfaction, and cost

• Subject matter expertise in inhaled Nitric Oxide (iNO) technology including intellectual property, patents in progress and technology applications

• Support and often own complex root cause investigations, DOE’s, issue resolution and other highly complex multi-disciplinary projects and programs.

• Support production, materials, commercial and service teams - provide responsive and effective problem solving support while ensuring minimal disruption to production output, product distribution or service

• Help achieve business goals for quality, customer satisfaction, cost and safety through analysis of production, service and customer complaint data and associated actions

• Cross-functional project participation and leadership of select initiatives that may involve external resources including engineering, testing, and other outsourced activities

• Expert technical guidance and mentoring of less experienced engineering resources.

• Support quality systems improvements related to fundamental improvements in product performance

• New product support - As a core member of a project team, provide expert design input and review to assure compliance to product requirements and design for manufacturability, serviceability and reliability. Team involvement in the design, development and documentation of product improvements and sourcing strategies.

• Regulatory compliance - awareness of existing SOP's and guidelines and involvement to keep them current as improved business practices are implemented

• Regulatory Affairs Support – system analysis and documentation development in support of worldwide regulatory compliance

• Product Safety – assist or lead in health hazard assessment or other field based product performance reviews, adverse events, medical device reports, field actions, recalls and other patient safety related activities.

• Other duties as assigned with or without accommodation.

Requirements:

Education

• Bachelors degree in Electrical Engineering or a related discipline.

• Master’s Degree preferred.

• Significant work experience (15yrs+) in medical devices may be substituted in lieu of degree.

Experience

• 10+ years of experience in medical device engineering, ideally in respiratory care or closely related field such as ventilators/electromechanical devices.

• Strong problem-solving skills, including complex system-level analysis of respiratory care clinical applications

• Strong logical reasoning skills and experience

• Ability to apply statistical techniques as appropriate

• Ability to create, read, interpret and critically review design documentation including component data sheets, mechanical and system-level specifications, electrical schematics and layouts, electrical and pneumatic diagrams and architecture diagrams

• Experience in developing and maintaining Failure Modes Effects Analysis documentation.

• Strong background in design for Electromagnetic Compatibility and related testing

• Successful experience as a member or leader of cross-functional project teams

Experience preferred:

• Experience in engineering/product support/manufacturing of nitric oxide delivery systems

• Strong medical device domain kno