Lead System Engineer.
This mandate is run by SYMPHONI HR, a Mumbai-based executive search firm, est. 2003. Applications are email-verified and reach the search team running the role — confidentially, always.
About the organisation.
Our client is a prominent global software and engineering services firm specializing in complex product development. They provide innovative technology solutions to highly regulated industries, focusing on delivering high-quality, safety-critical systems. With a strong commitment to engineering excellence, they foster a collaborative environment that encourages technical growth and professional development.
About the role.
We are looking for a Lead System Engineer to drive the development and integration of sophisticated medical device systems. You will oversee the full engineering lifecycle, ensuring that all designs meet rigorous global quality standards and clinical requirements. This role is based in Pune and operates on a hybrid work model.
What you will do.
- Lead the end-to-end Systems Engineering process for complex system-of-systems architectures.
- Oversee the full lifecycle of medical device development while ensuring strict adherence to ISO 13485:2003 standards.
- Collaborate with cross-functional teams to translate clinical requirements into robust Systems Design Engineering specifications.
- Manage technical documentation and validation protocols within a structured V-Model development framework.
- Ensure seamless integration across all system components to maintain high performance and safety.
- Drive innovation in health monitoring and medical product design through technical leadership.
What you bring.
- Bachelor’s or Master’s degree in Systems Engineering, Biomedical Engineering, or a related technical discipline.
- 4–12 years of professional experience in Systems Engineering and Engineering System Design.
- Proven expertise within the medical device or healthcare sector.
- Deep understanding of the V-Model methodology and its application in regulated environments.
- Demonstrated experience in Systems Design for medical applications and health monitoring solutions.
- Strong proficiency in managing quality compliance for medical devices under ISO 13485:2003.
- Familiarity with risk management frameworks related to medical device safety is highly desirable.
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