09 Oct
|
SolidPro - HelixA
|
Chennai
09 Oct
SolidPro - HelixA
Chennai
Job Description
Position: Medical Device Delivery Manager
Experience
10–15 years in medical device product development, engineering services, or healthcare/lifesciences product engineering.
Location
India | Hybrid / On-site as required
Role Overview
We are looking for an experienced Medical Device Delivery Manager to lead end-to-end delivery of medical device engineering and product development programs. The role will be responsible for managing customer engagements, engineering teams, project execution, quality, regulatory compliance, timelines, budgets, and successful product realization.
The ideal candidate should have robust experience in medical device development, design controls, risk management, verification & validation, and regulatory requirements, combined with excellent customer and program management skills.
Key Responsibilities
1. Program & Delivery Management
• Own end-to-end delivery of medical device development programs from concept through product launch.
• Define project scope, deliverables, milestones, resources, schedules, and budgets.
• Manage multiple concurrent projects and ensure on-time, on-budget delivery.
• Track project KPIs, risks, dependencies, issues, and change requests.
• Establish project governance, reviews, reporting, and escalation mechanisms.
2. Medical Device Product Development
• Lead multidisciplinary teams covering:
• Mechanical engineering
• Electronics & embedded systems
• Software / firmware
• Industrial design
• Systems engineering
• Verification & validation
• Prototyping and manufacturing engineering
• Ensure appropriate application of the medical device product development lifecycle.
• Drive requirements management, architecture, design reviews, design verification, validation, and transfer to manufacturing.
3. Quality & Regulatory
• Ensure projects comply with applicable medical device quality and regulatory requirements.
• Strong working knowledge of:
• ISO 13485
• ISO 14971
• IEC 62304
• IEC 62366
• IEC 6
📌 Medical Device Delivery Manager (Chennai)
🏢 SolidPro - HelixA
📍 Chennai