Medical Device Delivery Manager

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 strong 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 60601 series
• Design Controls / DHF
• Design Verification & Validation
• CAPA / NCR / Change Control
• Coordinate with regulatory and quality teams for technical documentation and submissions.
• Ensure traceability between user needs, requirements, risks, design outputs, and verification evidence.

4. Customer Management

• Act as the primary delivery interface for customers and stakeholders.
• Understand customer requirements and translate them into executable engineering plans.
• Conduct regular project reviews and communicate status, risks, and corrective actions.
• Build strong relationships with customer engineering, R&D, quality, regulatory, and procurement teams.
• Identify opportunities for additional engineering services and account growth.

5. Team Leadership

• Build and manage cross-functional engineering teams.
• Allocate resources based on project priorities and technical requirements.
• Mentor project managers, technical leads, and engineers.
• Promote engineering best practices, quality culture, and continuous improvement.

6. Risk & Issue Management

• Proactively identify technical, schedule, cost, quality, and regulatory risks.
• Drive mitigation and contingency plans.
• Lead root-cause analysis and resolution of critical project issues.
• Manage engineering changes and customer-driven scope changes.

7. Prototyping, Testing & Manufacturing

• Coordinate prototype development, EVT/DVT/PVT activities where applicable.
• Manage test planning, verification, validation, reliability, usability, and compliance testing.
• Work with suppliers and manufacturing partners for DFM/DFA and production readiness.
• Support design transfer and commercialization activities.

Required Skills

• Strong experience in medical device product development and delivery.
• Proven experience managing complex, multidisciplinary engineering programs.
• Strong understanding of medical device development processes and Design Controls.
• Experience with risk management and V&V.
• Good understanding of mechanical, electronics, software, systems, and manufacturing interfaces.
• Strong project planning, budgeting, resource management, and reporting skills.
• Excellent customer-facing and stakeholder-management capabilities.
• Strong problem-solving, communication, negotiation, and leadership skills.
• Experience working with global customers and distributed engineering teams is preferred.

Preferred Domain Experience

Experience in one or more of the following is desirable:

• Drug delivery devices
• Inhalation devices
• Wearable medical devices
• Diagnostic equipment
• Patient monitoring
• Surgical devices
• Electromechanical medical devices
• Medical electronics
• Digital health / connected medical devices
• Laboratory / analytical equipment
• Disposable and combination products

Education

Bachelor's or Master's degree in:

• Mechanical Engineering
• Electronics / Electrical Engineering
• Biomedical Engineering
• Mechatronics
• Medical Electronics
• Computer Science / Software Engineering

PMP, PMI, or equivalent program-management certification is an advantage.

Key Performance Indicators

• On-time project delivery
• Project profitability / budget adherence
• Customer satisfaction
• Engineering quality and first-pass success
• Risk and issue closure
• Resource utilization
• Compliance with medical device development processes
• Successful verification, validation, and product launch
• Customer retention and account growth