Senior Sustaining Engineer – Electrical

Mallinckrodt Pharmaceuticals•Madison, WI

2d•Onsite

About The Position

The Senior Sustaining Engineer – Electrical provides expert technical leadership and support to manufacturing, complaint, and service teams across sustaining, manufacturing, design, and quality engineering functions. This role is responsible for detailed failure investigation, including fault isolation to the component or subsystem level, root cause determination, and implementation of effective corrective actions. The position leads design changes and engineering change orders (ECOs) to improve product reliability, manufacturability, serviceability, safety, and cost. This position is responsible for identifying, developing, and executing key initiatives aligned with business objectives, including quality improvements, customer support, product lifecycle management, supply chain continuity, and new product introductions. Responsibilities include component obsolescence management, supplier engagement, and qualifications of alternate components or designs. The engineer ensures proper verification and validation of design changes and supports CAPA activities, regulatory compliance, and maintenance of design documentation in a cGMP-regulated medical device environment. A strong emphasis is placed on patient safety, product compliance, and customer satisfaction. As an active member of the product lifecycle management team, this role requires agility and resilience, with the ability to manage multiple priorities while maintaining a high level of technical execution and engineering rigor. Excellent written and verbal communication skills are essential.

Requirements

Bachelor’s degree in Electrical Engineering or related field (advanced degree preferred); equivalent medical device experience may substitute
5+ years of experience in complex medical device design, sustaining, manufacturing, or field/service engineering
Strong expertise in analog, digital, and mixed-signal circuit analysis and debugging
Proven ability in system-level troubleshooting across hardware, firmware, and integrated systems
Ability to perform fault isolation to the component/subsystem level and drive root cause resolution
Hands-on experience with lab equipment (oscilloscopes, logic analyzers, multimeters, power analyzers)
Experience with schematic review, PCB analysis, and implementing design changes (ECOs)
Knowledge of DFM, DFR, and design for serviceability principles
Experience supporting manufacturing, yield issues, and production problem resolution
Ability to drive corrective and preventive actions for field and internal quality issues
Experience with component selection, qualification, obsolescence management, and supplier engagement
Strong understanding of cGMP, ISO 13485, and regulated medical device environments
Experience with CAPA, complaint investigations, audits, and design documentation
Knowledge of risk management (ISO 14971), FMEA, and hazard analysis
Demonstrated structured problem-solving skills (e.g., 5-Why, Fishbone, DOE) with end-to-end ownership
Strong technical leadership and cross-functional collaboration skills, including influencing stakeholders
Excellent written and verbal communication skills for technical documentation and reporting

Nice To Haves

Experience with respiratory care or similar regulated electro-mechanical medical devices.
Strong background in pneumatic and electro-mechanical systems, including component selection and system integration.
Proficiency in analog and digital circuit design, analysis, and simulation.
Experience with PCB design, layout considerations, and electrical simulation tools.
Working knowledge of software architecture, logic, and hardware/firmware interaction.
Ability to interpret and apply product requirements, manufacturing requirements, and test specifications, including alignment to design intent and regulatory compliance.
Experience with mechanical engineering fundamentals (tolerance analysis, fit, manufacturability, and basic FEA interpretation).
Familiarity with EMC/EMI design practices and compliance testing.
Experience with environmental testing, product qualification, and reliability evaluation processes.
Knowledge of statistical methods for failure analysis, reliability, and process capability (e.g., Weibull analysis, Cp/Cpk).
Experience developing and supporting product test requirements and automated/semi-automated test systems.
Experience with component selection, qualification, lifecycle management, and obsolescence mitigation.
Proficiency with CAD tools (e.g., Creo/Pro-E, SolidWorks) for cross-functional collaboration.
Demonstrated experience with CAPA and structured quality system processes.
Experience leading small technical teams and managing engineering projects involving internal and external resources.
Ability to work with legacy products and mature designs while preserving design intent, ensuring regulatory compliance, and implementing necessary updates or improvements.

Responsibilities

Perform system-level troubleshooting of electro-mechanical and electro-pneumatic systems, including hardware/software interactions.
Conduct hands-on electrical engineering analysis (analog and digital) and detailed fault isolation to component or subsystem level.
Lead root cause investigations for field and internal product issues, ensuring clear problem replication and resolution.
Own and implement design changes (ECOs), driving solutions that improve product reliability, manufacturability, serviceability, and safety.
Drive corrective and preventive actions (CAPA) and resolve system-level design and production issues.
Lead and execute process and product changes to address both field failures and internal manufacturing/quality issues.
Ensure appropriate verification and validation of all design and process changes.
Collaborate with manufacturing, quality, service, and other engineering functions to resolve complex technical issues.
Provide technical leadership and oversight for small internal and external teams and actively contribute within cross-functional teams.
Conduct component research, selection, and qualification, including supplier engagement and technical evaluation.
Manage component obsolescence, alternate sourcing, and supply chain continuity.
Develop, improve, and ensure adherence to processes and procedures required for regulatory compliance in a cGMP medical device environment.
Support complaint investigations, CAPA activities, and design documentation, ensuring traceability and audit readiness.
Maintain a strong focus on patient safety, product quality, compliance, and customer satisfaction.
Demonstrate technical ownership and accountability across the full lifecycle from failure identification → root cause → validated solution implementation.