Systems Engineer

Position Name: Systems Engineer

Location: Pune

Experience: 5-12 years

About BinQle
BinQle is a global delivery and execution partner supporting enterprises across the US, India, Singapore and Australia. We specialize in structured hiring, managed teams, and long-term delivery support.

Role Summary:
Support EU MDR 2017/745 remediation programs for Class I, II, and III medical devices. Execute gap assessments, design control remediation, and requirements traceability to ensure compliance with regulatory standards.

What Youll Do:

• Conduct gap assessments for medical device documentation
• Remediate design history files (DHF) and related technical documentation
• Draft requirements and manage requirements traceability using the V-model
• Perform risk management, including DFMEA
• Collaborate cross-functionally to ensure compliance with EU MDR, ISO 13485, ISO 14971, and product standards

What We re Looking For (Must-Haves):

• Experience in medical domain
• System engineering skills
• DHF remediation expertise
• Gap assessment experience
• Knowledge of V-model and requirements trace matrix
• Experience in drafting requirements
• DFMEA proficiency

Good to Have (Optional - only if mentioned):

• As per requirement

Qualifications:
B.Tech / BE / ME / M.TECH / M.Pharma / M.SC

Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.