Senior Sustaining Engineer – Electrical

Mallinckrodt Pharmaceuticals; Alabama; On-site; USD 85,000 - 120,000; Full time

Benefits offered by this job

Total Rewards package including competitive pay and benefits

Job summary

Mallinckrodt Pharmaceuticals is seeking a Senior Sustaining Engineer – Electrical to provide expert technical leadership in manufacturing and design. The role involves detailed fault isolation, root-cause determination, and driving design changes to enhance product reliability.

This position requires a Bachelor's degree in Electrical Engineering or related field and 5+ years of experience in medical device environments. Responsibilities include system-level troubleshooting, managing supplier engagement, and ensuring compliance in a cGMP-regulated setting.

Qualifications

• 5+ years of experience in complex medical device design.
• Strong expertise in analog and digital circuit analysis.
• Proven ability in system-level troubleshooting.

Responsibilities

• Perform system-level troubleshooting of electro-mechanical systems.
• Lead root-cause investigations for product issues.
• Manage component obsolescence and supplier engagement.

Skills

Analog circuit analysis

Digital circuit analysis

System-level troubleshooting

Technical leadership

Compliance in cGMP

Problem-solving skills

Education

Bachelor's degree in Electrical Engineering

Tools

Oscilloscopes

Logic analyzers

Power analyzers

Job description

Senior Sustaining Engineer – Electrical (Open)

Requisition: JR000015832

Location: Madison, WI (Additional locations available)

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. It also identifies, develops, and executes 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 qualification 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.

Key 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 to root cause to validated solution implementation.

Qualifications

• 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.
• 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.

Preferred Skills

• 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.
• 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.

Organizational Relationship / Scope

This position operates cross‑functionally and collaborates regularly with Product Performance, Complaint Management, Service Support, Device Quality, Post‑Market Surveillance, Device Development, and Materials Management, as well as external partners, to address product lifecycle challenges and support new product introductions. It serves as a key technical resource, providing guidance, influencing decisions, and driving alignment across functions to ensure effective resolution of complex product issues.

Working Conditions

This role operates across a range of environments, including office, engineering laboratory, and medical device manufacturing areas, supporting hands‑on investigation, testing, and product support activities. The position requires engagement with both development and production settings to diagnose issues, validate design and process changes, and support ongoing product lifecycle needs. Domestic and international travel of up to 20% may be required to support manufacturing sites, suppliers, and field issue investigations.

Benefits

Keenova offers employees a Total Rewards package which includes competitive pay and benefits.

Equal Employment Opportunity Statement

Keenova 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.