Principal Electrical Engineer Medical Devices

1 day ago

Madison WI USA, United States Mallinckrodt Pharmaceuticals Full time
Job Title

Principal Electrical Engineer, Medical Devices

Job Summary

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.

Key Responsibilities
  • 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
Requirements
  • Bachelor's 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
  • 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
Preferred Qualifications
  • Experience in engineering/product support/manufacturing of nitric oxide delivery systems
  • Strong medical device domain knowledge – deep understanding of challenges inherent to nitric oxide delivery applications – accurate ratiometric delivery of pharmaceutical gases; trace gas sampling, sensing and analysis; tolerance and/or rejection of non-targeted compounds and ventilator interactions
  • Subject matter expertise in inhaled Nitric Oxide (iNO) technology
  • Mastery of electronics design tools such as Altium
  • Experience in the areas of reliability engineering, accelerated life testing, compliance testing, test automation and requirements management
  • Understanding of cGMP requirements, ISO 13485, safety agency testing and other regulatory requirements
  • Project management skills and experience
Working Conditions

Working conditions are those typically found in a final assembly and test environment for medical devices. Workspaces include office environment, sustaining engineering laboratory and device assembly environment. Some travel both domestic and international will be required up to 20%.

Mallinckrodt provides equal employment opportunities to applicants and employees without regard to race; color; gender; gender identity; sexual orientation; religions practices and observances; national origin; pregnancy, childbirth, or related medical conditions; protected veteran status; disability; or any other category protected by law.

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