The Systems Engineer will play a critical role as a part of the Patient Interface (Masks) R&D Engineering Team, responsible for developing and 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're the right fit if:
You’ve acquired a minimum of 5 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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If you’re interested in this role and have many, but not all, of the experiences needed, we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips. Learn more about our commitment to diversity and inclusion here.#LI-PH1It is the policy of Philips to provide equal employment and advancement opportunities to all colleagues and applicants for employment without regard to race, color, ethnicity, religion, gender, pregnancy/childbirth, age, national origin, sexual orientation, gender identity or expression, disability or perceived disability, genetic information, citizenship, veteran or military status or a person’s relationship or association with a protected veteran, including spouses and other family members, marital or domestic partner status, or any other category protected by federal, state and/or local laws.As an equal opportunity employer, Philips is committed to a diverse workforce. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants that require accommodation in the job application process may contact 888-367-7223, option 5, for assistance.Equal Employment and Opportunity Employer/Disabled/Veteran