Company:A Large Global Organization

Key Skills: Medical Imaging Systems, Product Safety Engineering, Regulatory Compliance, Safety Regulations, Product Security, Risk Management, Hazard Analysis, Systems Engineering, Medical Device Development, Certification and Compliance Frameworks

Roles & Responsibilities:

- Define and implement product safety engineering methods for medical imaging equipment and related devices.
- Interpret applicable regional and national regulations, standards and certification requirements, and communicate their impact to engineering teams.
- Identify, evaluate and mitigate safety and product security risks throughout new product development and product changes.
- Coordinate compliance reviews, third-party testing, certification activities and resolution of findings with engineering, quality and supply chain teams.
- Lead technical discussions and small-to-medium projects, providing guidance to engineers and driving decisions that meet product quality, performance and schedule objectives.

Skills Required:





- Demonstrated experience in recent product development for complex medical, healthcare or regulated products.
- Strong knowledge of regulatory compliance and safety regulations compliance, including interpretation and application of technical standards.
- Hands-on experience with product security considerations across the product lifecycle.
- Ability to translate safety, regulatory and security requirements into system-level design inputs, verification activities and certification evidence.

Good to Have:

- Experience in formal risk assessment, hazard analysis or risk-based design for medical devices.

Education:

- Bachelor's degree in Engineering, Technology or a related technical discipline from an accredited university or college.
- 7 - 16 years of relevant experience in safety engineering, regulatory engineering, systems engineering, product compliance or medical device development.

📌 Safety & Regulatory Engineer (Bengaluru)
🏢 MyCareernet
📍 Bengaluru