Sleep and Respiratory Systems Engineer
2 weeks ago
Sleep and Respiratory Systems Engineer
Role Summary
The Systems Engineer will be integral to the Sleep and Respiratory Care Research & Development/Systems Engineering Team, tasked with the innovation and maintenance of respiratory ventilators and sleep therapy apparatus, ensuring that our Sleep & Respiratory Care (S&RC) offerings meet the highest standards of safety, reliability, and quality.
Key Responsibilities:
- Oversee all Systems Engineering deliverables and processes, translating user and business needs into product specifications, developing technical strategies, and system architecture, while ensuring design coherence across relevant products and projects.
- Facilitate the refinement and translation of user needs (including clinical, serviceability, reliability, and manufacturability), regulatory standards, and system architecture into actionable functional requirements. Ensure compliance with requirement management policies and guarantee comprehensive coverage and quality of requirements.
- Lead the technical approach, system-level design, assess the feasibility of potential technical solutions, and distribute derived requirements (including functionality, interface specifications, and design budgets) across impacted subsystems.
- Plan and conduct system-level design evaluations.
- Manage system-level defect analysis and resolution during the System Integration, Verification, and Validation phases.
- Support Product Risk Management, regulatory compliance, and approval processes.
- Mitigate technical risks through comprehensive risk assessments, including Design Failure Mode and Effects Analysis (DFMEA), and implement risk control strategies.
- Reporting to the Director of Systems Engineering, collaborate with a diverse team of engineers and specialists across the Sleep & Respiratory Care division.
- This hybrid role may involve occasional travel.
- A minimum of 3 years of experience in developing complex medical devices with a focus on systems engineering (hardware, software, consumables), particularly in Sleep Therapy/Ventilation products and accessories.
- Strong grasp of the System Design process, including Model-Based/V-Model design methodologies, encompassing conceptualization, requirements documentation, functional and technical design, verification, integration, and validation.
- Experience with test-driven design approaches, analytical and architectural thinking, system perspective, practical insight, adaptability, and a hands-on approach to achieving sustainable results and innovative solutions.
- Excellent communication, documentation, presentation, and interpersonal skills, with the ability to work independently and collaboratively across functions.
- In-depth knowledge of Medical Device/FDA Quality System Regulations (ISO 13485/14971/10993/18562, IEC 62366, etc.) and clearance procedures.
- A demonstrated commitment to Patient Safety and Quality as core organizational values.
- A minimum of a bachelor's degree in engineering (Systems, Biomedical, Mechanical, or a related field) is required; a master's degree is preferred.
- Ability to meet the minimum physical, cognitive, and environmental job requirements with or without accommodation.
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