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Location: Pune
Company: Philips
In this role, you have the opportunity to
Be an integral part of the Emergency Care and Resuscitation (ECR) R&D leadership team, actively participating in cardiac defibrillator product development. ECR team has a broad product portfolio of advanced life support solutions, automated external defibrillators, and data management solutions. Our mission is to design, produce, and deliver every solution as if the life of someone we love depends on it. Every day, we empower and enable our customers – from clinicians to paramedics, first responders to the everyman – to save lives using our innovative, market-leading technology.
We are looking for a passionate Systems Designer to join us as we strengthen our product portfolio, expand our services and solutions, and bring game-changing technology to market. This team member will be responsible for working collaboratively with a team of cross-functional engineers.
You are responsible for
- Assists with the “High Level” systems view of our product design (architecture and system requirements) and how it fits within a larger product portfolio, including ensuring proper allocation and ownership of requirements to the subsystem and component levels.
- Derives requirements from high-level marketing requirements into product-level functional requirements.
- Ensures that the design is consistent with the higher-level architecture and requirements.
- Ensure that the proposed design would have the safety, reliability and quality features built-in
- Ensures that design modules meet the product certification requirements
- Is abreast of / participates in standards identification responsible for designing.
- Supports the safety risk management implementation and compliance.
- Coordinates with User Interface, Engineering, Marketing, Procurement, Operations, and V&V teams.
- Participates in design reviews, including reviews of design inputs and outputs.
- Keeps abreast of new developments in all relevant technological domains.
- Contributes to technology roadmaps and other strategic related activities.
You are a part of
This position resides in EC (Emergency Care and Public Access) Business Category within the Connected Care Cluster. Emergency Care is expanding access to and quality of respiratory care, resuscitation, and emergency care solutions (including devices, services, and digital/data solutions). We are the number one provider of therapeutic care solutions, saving and improving more and more lives every year.
This role will be based in our Pune office and will report to the Emergency Care R&D Leader in Pune, India. This is a very exciting time to be joining Philips, as this new location will be emerging as a strong engineering team in Emergency Care product development
To succeed in this role, you should have the following skills and experience
- Bachelor’s degree in Electrical/Electronics/Mechanical Engineering or related field, good to have Master’s degree.
- Total 5+ years’ experience with minimum 3 years of experience in medical device or other similar industry..
- Knowledge of global quality and regulatory environment for medical devices including FDA CFR 21 part 820.30 and IEC 60601-1-1 (CE mark), ISO 13485, and risk management requirements and development dependencies.
- Solid understanding of medical device product development, preferably Design Control experience with Class-III/Class-3 medical devices (FDA CFR Title 21, 820.30).
- In-depth understanding of both hardware and software for integrated products.
- Strong understanding of safety risk management, including FMEA, design mitigations, and compliance to risk management standards.
- Working knowledge of tools and processes related to system configuration management from specifications development, traceability, version control, defect tracking, and field feedback.
- Experience distilling requirements from the system level into lower-level electrical and mechanical requirements.
- Understanding of digital signal processing and algorithm concepts.
- Experience in designing and assessing compliance to national/international standards.
- Experience with designing fault-tolerant systems.
- Proven ability to communicate in both verbal and written form to technical and non-technical customers, stakeholders, and various levels of management.
- Develops and maintains effective relationships and is capable of quickly earning trust and respect.