Principal Systems Architect (Medical Devices - Hardware)

Natus Medical Incorporated; India; À distance; INR 900 000 - 1 500 000; Plein temps

Avantages offerts par ce poste

Remote work

Global team

Career growth

Résumé du poste

Natus Medical Incorporated is seeking a Principal Systems Architect to define and drive the architecture of next-generation medical devices from concept through commercialization. This leadership role requires coordinating hardware, electronics, firmware, software, quality, regulatory, and manufacturing across global teams.

You will own system requirements, architecture documentation, interfaces, and traceability while leading architectural reviews, risk assessments, and MBSE practices to ensure

Qualifications

• Bachelor's degree in Engineering, Electronics/ Biomedical/ Systems/ Mechanical Engineering or related field.
• 12+ years in developing regulated medical devices or complex electromechanical products.
• 5+ years in a Principal Engineer or equivalent leadership role.

Responsabilités

• Lead architecture and technical strategy for complex medical device platforms focusing on hardware and electromechanical systems.
• Define system architectures balancing customer needs, regulatory compliance, manufacturability, and scalability.
• Translate requirements into system-level solutions and own architecture documentation and traceability.
• Drive decision-making across hardware, electronics, firmware, software, and mechanical teams.

Connaissances

Hardware architecture

Embedded systems

Electromechanical

Systems engineering

Requirements mgmt

Risk management

Design controls

Validation

Regulatory standards

Technical leadership

Product leadership

Formation

Bachelor's degree in Engineering

Master's or PhD (preferred)

Outils

Jama

DOORS

Polarion

Enterprise Architect

Cameo

Description du poste

Remote | India

Design the Future of Medical Technology

Are you an experienced systems architecture leader with deep expertise in medical device hardware and electromechanical systems? We're looking for a Principal Systems Architect to define and drive the architecture of next-generation medical devices that improve patient outcomes worldwide.

This is a highly influential technical leadership role where you'll shape product strategy, establish system architecture frameworks, and guide complex engineering decisions from concept through commercialization. Working across global teams, you'll bring together hardware, electronics, mechanical engineering, firmware, software, quality, regulatory, and manufacturing disciplines to deliver innovative and compliant medical technologies.

What You'll Do

• Lead the architecture and technical strategy for complex medical device platforms, with a strong focus on hardware and electromechanical systems.
• Define system architectures that balance customer needs, clinical requirements, regulatory compliance, manufacturability, and product scalability.
• Translate user, business, and regulatory requirements into robust system-level solutions.
• Own system requirements, architecture documentation, interfaces, and traceability throughout the product lifecycle.
• Drive technical decision-making across hardware, electronics, firmware, software, and mechanical engineering teams.
• Lead architectural reviews, design reviews, and technical risk assessments.
• Develop system integration, verification, and validation strategies.
• Drive reliability engineering, risk management activities, and design controls in accordance with medical device regulations.
• Identify and mitigate technical risks early in the development process.
• Mentor engineering teams and promote best practices in systems engineering and architecture development.
• Partner with Quality, Regulatory, Manufacturing, and Product Management teams to ensure successful commercialization.

What You'll Bring

Essential Requirements

• Bachelor's degree in Engineering, Electronics Engineering, Biomedical Engineering, Systems Engineering, Mechanical Engineering, or a related technical discipline.
• 12+ years of experience developing regulated medical devices or complex electromechanical products.
• 5+ years in a Principal Engineer, Systems Architect, Lead Systems Engineer, or equivalent technical leadership role.
• Proven track record of leading products from concept through commercialization.
• Strong expertise in:
  • Medical device hardware architecture
  • Electronics and embedded systems design
  • Electromechanical product development
  • Systems engineering principles and architecture methodologies
  • Requirements management and traceability
  • Risk management, reliability engineering, and DFMEA
  • Design controls, verification, and validation
• Experience making architecture decisions across multidisciplinary engineering organizations.
• Strong understanding of FDA, MDR, IEC, ISO, and other applicable medical device standards.

Nice to Have

• Experience with neurodiagnostics, patient monitoring, imaging, surgical, wearable, or connected medical devices.
• Knowledge of embedded software, connectivity technologies, cybersecurity, and cloud-enabled healthcare solutions.
• Experience with tools such as Jama, DOORS, Polarion, Enterprise Architect, Cameo, or similar systems engineering platforms.
• Exposure to Model-Based Systems Engineering (MBSE).
• Experience supporting regulatory submissions including FDA, MDR, CE Mark, and international market approvals.
• Master's degree or PhD in a relevant engineering discipline.

Success in This Role

• A strategic technical leader who can see the complete system while understanding the details that matter.
• Passionate about developing innovative medical technologies that improve patient care.
• Highly experienced in hardware architecture, electronics, and electromechanical system design.
• Comfortable influencing senior stakeholders and driving alignment across global teams.
• Skilled at balancing technical excellence, regulatory requirements, cost, quality, and time-to-market objectives.
• A collaborative mentor who elevates engineering capability across the organization.
• Driven to solve complex technical challenges and create scalable product platforms.

Why Join Us?

• Work remotely from anywhere in India.
• Competitive compensation and benefits package.
• Be the technical authority behind next-generation medical device platforms.
• Influence product strategy and architecture at a global level.
• Collaborate with world-class international engineering and product teams.
• Work on innovative technologies that make a meaningful difference in patients' lives.
• Mentor and develop future engineering leaders while shaping the direction of our products.

EEO Statement: Natus Medical is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, veteran status, disability, sexual orientation, gender identity, or any other protected status.