Sr Eng, Codes and Standards

Overview

Sr Eng responsible for product systems architecture and systems engineering for medical devices, including requirements management, traceability, validation support, and systems integration. Also covers standards/compliance coordination for assigned programs and global certification activities.

What you'll do

• Coordinate and develop product systems architecture and systems-level design, including decomposition into subsystem and interface specifications.
• Perform systems engineering across the product lifecycle from new product development through post market surveillance.
• Gather requirements inputs from standards, user needs, regulatory, quality, human factors, manufacturing, and service.
• Conduct requirements impacts assessment for proposed design/material/process changes and field/service observations, and define mitigations with rationale.
• Create and maintain Design History File elements and ensure adherence to FDA, ISO, and IEC design control procedures.
• Develop test plans/protocols/reports for product integration testing and maintain traceability from requirements to verification and design entities.

What you'll need

• 8-10 years of relevant technical experience defining systems and requirements for medical products.
• Strong knowledge of engineering disciplines including Electromechanical, Systems, Fluid Mechanics, and Materials Sciences.
• Demonstrated track record in electromechanical system development, preferably medical devices or other highly regulated products.
• Strong analytical skills for resolving complex technical problems.
• Excellent written, oral, and interpersonal skills, including time management and multitasking.
• As Compliance Engineer: knowledge of medical device requirements for global regions (US, Canada, Europe, Korea, Japan, Australia/New Zealand, Latin America, Caribbean, MEA).

Details

• Location: Bangalore, Karnataka.
• Workplace flexibility policy includes a minimum of 3 days a week onsite.