Technical Manager - Systems Engineering & Systems Design

Job Description: Technical Manager - Systems Engineering & Systems Design

Domain: Medical Devices / MedTech R&D

Role Type: Ground-up Capability Development | Technical Leadership | People & Technology Management

Position Summary

Lead the establishment, scaling and institutionalization of Systems Engineering and Systems Design capabilities for next-generation medical devices, connected health platforms and integrated hardware-software systems. This role requires a highly hands-on technical leader capable of defining system architectures, requirements engineering frameworks, system decomposition strategies, verification methodologies and cross-functional engineering integration while building a high-performance Systems Engineering organization.

Key Responsibilities

• Develop and deploy the Systems Engineering operating model across product development programs.

• Define end-to-end systems engineering lifecycle, processes, methods, templates and governance.

• Lead system architecture development for medical devices, embedded systems, digital health and connected platforms.

• Establish requirements engineering, traceability and systems decomposition frameworks.

• Drive system-level design reviews and architecture reviews.

• Lead interface management between hardware, software, firmware, mechanical, electrical, clinical and quality functions.

• Establish verification and validation strategies aligned with product requirements.

• Drive Model-Based Systems Engineering (MBSE) adoption where applicable.

• Build capability in risk-driven system design and product safety engineering.

• Recruit, mentor and develop systems engineers and technical leads.

• Collaborate with Regulatory, Quality and Clinical teams for compliant product development.

People Leadership Responsibilities

• Build and lead a high-performing Systems Engineering team.

• Establish competency frameworks, mentoring programs and technical career paths.

• Drive engineering excellence, design rigor and knowledge management.

• Foster strong collaboration across global and cross-functional teams.

Required Qualifications

• Bachelor's or Master's degree in Systems Engineering, Electrical, Electronics, Biomedical, Mechanical, Software Engineering or related discipline.

• 12+ years of engineering experience with significant medical device product development exposure.

• 5+ years leading technical teams, architecture teams or systems engineering functions.

• Demonstrated experience delivering complex integrated hardware and software products.

Technical Expertise

• Systems Architecture and Product Architecture Development.

• Requirements Engineering and Traceability Management.

• Hardware-Software Systems Integration.

• Design Trade-off Analysis and System Modeling.

• Verification & Validation Planning.

• Reliability, Safety and Risk-Based Design.

• Root Cause Analysis and Problem Solving.

• Product Lifecycle Management and Configuration Management.

• MBSE tools and architecture modeling methodologies preferred.

MedTech & Compliance Knowledge

Strong understanding of ISO 13485, ISO 14971, IEC 60601 family, IEC 62304, IEC 62366, CDSCO regulations, FDA Quality System Regulations/QMSR, EU MDR and design control expectations. Experience integrating systems engineering deliverables with Design Controls, DHF and regulatory submissions.

Preferred Certifications

• INCOSE ASEP/CSEP/ESEP certifications.

• Systems Engineering or Architecture Certifications.

• ISO 13485 Internal Auditor or Lead Auditor Certification.

• ISO 14971 Risk Management Training.

• Project Management and Agile Product Development Certifications.

Core Competencies

Systems Thinking, Architecture Leadership, Technical Depth, Innovation, Stakeholder Management, Product Safety, Team Development, Strategic Planning, Technical Decision Making, Communication and Influencing.

Success Measures

Successful establishment of Systems Engineering capability; scalable systems architecture practices; robust requirements traceability; reduced integration issues; successful product launches; strong engineering team growth; improved system quality, safety and regulatory readiness.