Job Information
Mallinckrodt Pharmaceuticals Principal Electrical Engineer, Medical Devices in Madison, Wisconsin
Job Title
Principal Electrical Engineer, Medical Devices
Requisition
JR000014344 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 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
Organizational Relationship/Scope:
This position routinely interacts with colleagues, including those responsible for but not limited to Product Performance, Complaint Management, Service Support, Device Quality, Post Market Surveillance, Device Development, Materials Management and external resources required to appropriately address all product life cycle issues and new product introduction. This is an advanced level role requiring in-depth product and therapy understanding across multiple use cases. In-depth understanding of key stakeholder needs is essential, as this role will often interact cross- functionally as a technical resource.
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%.
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At Mallinckrodt, we know that we contribute to something that matters because we make quality products that impact patient lives. Our dynamic work environment provides unique experiences for employees to grow and develop.
Invest in your own career with Mallinckrodt and let’s do something dynamic together.
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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