Systems Engineer (18 months FTC)

The Systems Engineer II within the Product Lifecycle Engineering (PLE) team supports released obstructive sleep apnea (OSA) products by maintaining system-level requirements, interfaces, performance, safety, quality and reliability throughout the product lifecycle. The role assesses system-level implications of changes, and collaborates with Electrical, Mechanical, Software, Manufacturing, Quality, Regulatory and other stakeholders to implement appropriately verified solutions. The engineer is expected to independently deliver defined sustaining engineering activities and seek support or escalate when technical complexity or product risk warrants it.

Let's talk about Responsibilities

• Maintain and update system-level requirements, specifications, architecture and interface documentation for released products in response to approved changes and lifecycle needs.

• Investigate field, service and manufacturing issues by evaluating device performance, system interactions, use conditions and available data; document findings and proposed corrective actions.

• Identify system design weaknesses and performance gaps, and recommend practical improvements to reliability, usability and lifecycle performance.

• Assess the system-level impact of component substitutions, obsolescence, supplier changes, software updates and other sustaining design changes, including potential unintended effects across subsystems.

• Define or update system verification requirements and acceptance criteria; develop and execute or coordinate testing, evaluate results and maintain traceability to relevant requirements.

• Participate in product risk management activities, including hazard analysis, design risk assessment and evaluation of risks introduced by changes, in collaboration with Quality and Regulatory teams.

• Ensure assigned work considers applicable product safety, quality and regulatory requirements and follows established design-control and change-management processes.

• Collaborate across disciplines to resolve interface issues and align system-level engineering decisions, deliverables and timelines.

• Contribute to design reviews, technical investigations, root-cause analysis, post-market analysis and engineering change documentation with clear technical evidence and rationale.

• Share technical learnings and systems engineering practices with colleagues; independently manage assigned tasks and escalate unresolved or high-risk technical concerns.

Let's talk about Qualifications and Experience

Required

• Bachelor's degree in Systems, Electrical, Mechanical, Biomedical Engineering or a related engineering discipline.

• Minimum of 6 years of relevant engineering experience, including experience in systems engineering, product development or sustaining engineering.

• Sound understanding of systems engineering principles: requirements management, system architecture, interface definition, system integration and verification.

• Demonstrated ability to investigate cross-disciplinary technical problems, apply structured root-cause analysis and translate findings into actionable design or process improvements.

• Experience assessing engineering changes and documenting verification evidence, technical rationale and associated risks.

• Familiarity with product risk management methods, including hazard analysis and DFMEA, and with design control and change management processes.

• Working knowledge of relevant medical device quality, safety and regulatory requirements, with the ability to seek specialist guidance when needed.

• Strong analytical, written communication and stakeholder collaboration skills; ability to manage assigned work with limited day-to-day supervision.

Preferred

• Experience sustaining released medical devices, particularly connected electromechanical products or sleep and respiratory care devices.

• Experience in system verification, field issue investigation, post-market data analysis and cross-functional technical coordination.

• Experience using requirements traceability or engineering lifecycle management tools.

• Experience applying data analysis, automation or AI-enabled tools responsibly to improve engineering productivity.

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Joining us is more than saying “yes” to making the world a healthier place. It’s discovering a career that’s challenging, supportive and inspiring. Where a culture driven by excellence helps you not only meet your goals, but also create new ones. We focus on creating a diverse and inclusive culture, encouraging individual expression in the workplace and thrive on the innovative ideas this generates. If this sounds like the workplace for you, apply now! We commit to respond to every applicant.