Senior Biomedical Engineer

We are seeking a highly skilled Senior Biomedical Engineer to serve as the critical bridge between engineering design and clinical application across our diverse portfolio of medical devices, which includes life-critical systems (ventilators, CPAP/BiPAP, robotic surgical platforms) and patient-facing wearable devices. This role requires deep knowledge of human physiology, regulatory standards, and design control to translate complex clinical needs into robust engineering requirements and ensure final product safety, efficacy, and comfort. About the Role We are seeking a highly skilled Senior Biomedical Engineer to serve as the critical bridge between engineering design and clinical application across our diverse portfolio of medical devices, which includes life-critical systems (ventilators, CPAP/BiPAP, robotic surgical platforms) and patient-facing wearable devices. This role requires deep knowledge of human physiology, regulatory standards, and design control to translate complex clinical needs into robust engineering requirements and ensure final product safety, efficacy, and comfort. Responsibilities Clinical & Regulatory Translation Requirements Generation: Act as the primary interface with clinicians and patients to gather user needs and translate them into detailed, verifiable engineering design requirements for all cross-functional teams. Risk Management: Lead and maintain the Risk Management File ($ISO 14971$) throughout the product lifecycle, specifically identifying and mitigating patient- or user-related biological, physiological, and human factors risks. Standards Compliance: Ensure device designs and testing protocols meet relevant medical device standards, including ISO 13485, IEC 60601, and specific standards for wearable health technology. Design, Testing, and Validation Biocompatibility & Material Selection: Drive the biological evaluation planning and advise engineering on the selection of all materials (polymers, silicones, metals) to ensure biocompatibility ($ISO 10993$ series) and long-term safety for continuous skin contact. Usability and Human Factors: Lead the Human Factors Engineering (HFE) and Usability Studies for both complex clinical systems and simple, consumer-friendly wearables, optimizing device interaction and minimizing the potential for clinical errors. Clinical Performance & V&V: Develop, coordinate, and execute pre-clinical verification and validation ($V&V$) tests that accurately simulate the human biological environment, focusing on signal integrity for wearables (e.G., maximizing $ECG/PPG$ fidelity during movement). Physiological Modeling: Apply principles of human anatomy and physiology to model device interaction, such as lung mechanics for ventilators or biomotion and skin impedance for wearable sensors. System Support for Diverse Products Provide technical expertise on miniaturization constraints and sensor integration specific to wearable devices. Serve as a Systems Engineer to ensure the safe and reliable integration of mechanical, fluidic, electronic, and software sub-systems as they relate to patient interaction and data acquisition. Collaborate closely with Quality Assurance to execute Design Failure Mode and Effects Analysis ($DFMEA$). Qualifications Required Experience and Expertise Professional Experience: 5+ years of experience in biomedical engineering, systems engineering, or medical device product development in a regulated environment. Proven experience bringing at least one complex medical device (Class II or III) or high-reliability wearable device through the design control process to market. Direct experience working with either respiratory systems (pneumatics/fluid dynamics) or body-worn/skin-contact devices. Essential Technical Skills: Wearable Design Acumen: Specific knowledge of ergonomics, comfort, and ingress protection (IP) sealing for devices intended for long-term body contact. Biocompatibility: Deep working knowledge of $ISO 10993$ series and practical experience managing biological evaluation plans. Design Control: Expert knowledge of the $FDA$ Quality System Regulation ($21 CFR 820$) and $ISO 13485$ design controls. Analytical Tools: Proficiency with relevant engineering and statistical tools (e.G., MATLAB, LabVIEW, or Minitab for data analysis). Education Minimum: Bachelor's degree in Biomedical Engineering, Bioengineering, or a closely related engineering discipline. Preferred: Master's degree in Biomedical Engineering or Clinical Engineering.