System Engineer Medical Domain Pune

Teamplus Staffing Solution; Pune District; On-site; INR 1,200,000 - 1,800,000; Full time

Job summary

Teamplus Staffing Solution is seeking a Systems Engineer to support EU MDR 2017/745 remediation for medical devices (Class I–III) in Pune. The role involves gap assessment, design control remediation, and requirements engineering to ensure compliance with EU MDR, ISO 13485 and ISO 14971.

The position requires a strong background in medical devices, DHF remediation, DFMEA, and traceability management, with 5–12 years of relevant experience. Office-based with hybrid options may be considered.

Qualifications

• B.Tech/BE/ME/M.TECH/M.Pharma/M.SC or equivalent qualification.
• 5–12 years of experience in system engineering or medical devices domain.
• Domain-Medical industry background mandatory.

Responsibilities

• The Systems Engineer will support EU MDR 2017/745 remediation programs for Class I, II and III medical devices.
• The role includes gap assessment, design control remediation, requirements engineering and risk management.

Skills

System engineer

DHF Remediation

Gap assessment

V-model

Requirements trace matrix

Requirements drafting

DFMEA

Domain-Medical

Job description

Dear Candidate,

We are having an opening for System Engineer - EU MDR 2017/745- Domain-Medical - Pune

Mandatory Skills

• System engineer
• DHF Remediation
• Gap assessment
• V-model
• Requirements trace matrix
• Requirements drafting
• DFMEA
• Domain-Medical (Mandatory)

• Position / DesignationSystem Engineer
• QualificationB.Tech/BE/ME/M.TECH/M.Pharma/M.SC
• Years of Experience5-12 Years
• Office / Remote / Hybrid
• OfficeNumber of post20
• Office LocationPune- Near Hijewadi client location
• GenderMale / Female
• Industry BackgroundDomain-Medical (Mandatory)
• Annual CTC / SalaryAs Per Industry Standard
• Selection Process2 Technical round

Job Role & Responsibility

The Systems Engineer will support EU MDR 2017/745 remediation programs for Class I, II and III medical devices. The role involves gap assessment, design control remediation, requirements engineering, traceability management, risk management, technical documentation updates, and cross-functional collaboration to ensure compliance with EU , MDR, ISO 13485, ISO 14971 and applicable product standards.

Skills

• System engineer
• DHF Remediation
• Gap assessment
• V-model
• Requirements trace matrix
• Requirements drafting
• DFMEA

Joining Date

Immediate to 1 Month