Systems Engineer

Proffer It Consultancy; Pune District; On-site; INR 1,200,000 - 1,800,000; Full time

Job summary

BinQle is seeking a Systems Engineer to support EU MDR remediation programs for medical devices. You will conduct gap assessments, remediate DHF, draft requirements and manage traceability using the V-model, while performing risk management including DFMEA.

Collaboration with cross-functional teams is essential to ensure compliance with EU MDR and ISO standards. The role targets professionals with 5–12 years of experience in Pune, India, with a background in engineering and medical devices.

Qualifications

• Experience in the medical device domain.
• Knowledge of V-model and requirements traceability.
• Experience drafting requirements and performing DFMEA.

Responsibilities

• 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 regulatory compliance.

Skills

Medical domain experience

System engineering

DHF remediation

Gap assessment

V-model knowledge

Requirements drafting

DFMEA proficiency

Education

B.Tech / BE / ME / M.Tech / M.Pharma / M.SC

Job description

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