Member Technical Staff (Level 1)

Overview

Member Technical Staff (Level 1) to support requirements, risk, regulatory/compliance, traceability, and verification/validation for an In Vitro Diagnostic (IVD) Class II device (table-top blood gas analysis).

What you'll do

• Coordinate engineering workstreams to produce requirements documents.
• Run risk management activities per client-defined procedures.
• Create and maintain a traceability matrix.
• Provide regulatory and compliance requirements to engineering workstreams and review artifacts.
• Support V&V (verification and validation) activities.
• Create and own the DHF following the client design control process.

What you'll need

• Have 7+ years of experience.
• Have at least 5 years of experience in medical devices.
• Have a good understanding of embedded products.
• Understand medical device regulations including ISO 13485.
• Understand medical device regulations including ISO 14971.
• Understand medical device regulations including IEC 62304.
• Understand medical device regulations including IEC 60601.

Details

• Employment type: Full time.
• Location: Pune, Blue Ridge-Hinjewadi (IN-MH-Pune, India-Blue Ridge-Hinjewadi).