Senior Systems Engineer-Patient Interface

Job Title
Senior Systems Engineer-Patient Interface

Job Description

The Senior Systems Engineer will play a critical role as a part of the Patient Interface R&D Engineering Team, responsible for developing/evaluating sleep/ventilation therapy masks and wearables, as well as providing a superior level of technical/product support, ensuring our Sleep & Respiratory Care (S&RC) products are safe, reliable and of the highest quality.

Your role:

• Incorporates essential operating mechanisms of systems engineering of medical device design and engineering principles and adheres to medical device regulations.
• Defines User Requirements, system requirements, FMEA, architecture, and interfaces to meet product requirements, risk analysis and industry standards; conducts system design analysis to select key components and defines control methods; and coordinates build and design integration.
• Works together to support product verification and validation planning, resolution of technical integration issues, safety agency interface, system testing and coordination.
• Conducts design reviews as part of the product development process to ensure customer requirements are met and the designs are manufacture-able, serviceable, and reliable. In addition, it does the same for subsystem requirements and product integration.
• Leadership: Drive critical initiatives by encouraging and channeling the contributions of others; recognizing and addressing critical issues in a timely manner and acting as an agent for change and continual improvement when required to achieve results. Leads or contributes to setting technical direction and establishes a standard of work for the team.
• Working in Ambiguity: Take underdefined/complex issues and set direction to resolve them in an aligned manner with stakeholders.
• Adaptability: Must be able to understand new concepts quickly and apply them accurately throughout an evolving environment and organize work assignments to meet established timetables.
• Data-driven decision-making : Move teams through vague and complex situations. Present complex ideas in a simple manner to resolve issues.
• Reporting to the Manager of Core Research & Advanced Development, you will collaborate with a cross functional team of engineers and specialists throughout the Sleep & Respiratory Care organization.
• This Hybrid , Pittsburgh, PA based role, may require travel up to 10%.

• You've acquired a minimum of 10 years' experience successfully developing complex medical devices (hardware, software, consumables) and a focus in systems engineering-V-model, starting with conceptualization, writing requirements, functional and technical design, check & optimize, verification, integration and finally the validation. Experience in Sleep Therapy/Ventilation products and accessories highly desired.
• You have a strong understanding of System Design process, including Model-Based (MBSE) Design approach, Test-Driven design methodologies, analytical and architectural thinking, system view, physical insight, flexibility, and a hands-on mentality to deliver sustainable results and creative solutions.
• You have effective communication, computer, documentation, presentation, and interpersonal skills, as well as the ability to work independently, cross-functionally, and collaboratively.
• You have strong knowledge of Medical Device/ FDA Quality System Regulations (ISO 13485/14971/10993/18562 ,17510 2015, IEC 62366 etc.) and clearance processes.
• You've demonstrated a relentless focus on Patient Safety and Quality as an organizational value .
• You have a minimum of a Bachelor's Degree in Engineering- Systems, Biomedical, Mechanical or similar discipline (required), Master's degree (preferred).
• You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position .
• US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa, now or in the future.

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