Hardware Systems Engineering Manager

BioTalent; Massachusetts; On-site; USD 120,000 - 150,000; Full time

Job summary

A leading organization in medical technology is seeking a Hardware Systems Engineering Manager to guide a multidisciplinary team developing next-generation surgical platforms. The role involves leading the development of complex hardware, ensuring compliance with medical device standards, and mentoring engineers. Ideal candidates will possess a Master’s or PhD in Mechanical or Electrical Engineering, along with 8+ years in engineering and strong leadership skills in regulated environments. This position is based in the United States, Massachusetts.

Qualifications

• 8+ years of experience in systems or hardware engineering with strong mechanical and electrical foundations.
• 3+ years of leadership experience within regulated industries, preferably in medical devices.
• Knowledge of regulatory frameworks including FDA requirements and IEC 60601.

Responsibilities

• Lead the creation of complex hardware platforms and oversee design efforts.
• Ensure compliance with medical device standards and manage system requirements.
• Identify emerging technologies to enhance future product roadmaps.

Skills

Leadership

Mechanical Engineering

Electrical Engineering

Systems Engineering

Communication

Education

Master’s degree or PhD in Mechanical or Electrical Engineering

Tools

CAD

PCB design software

Job description

Overview

A leading organization in the medical technology space is seeking a Hardware Systems Engineering Manager to guide a multidisciplinary team developing next-generation surgical navigation platforms. This role blends strong mechanical and electrical engineering expertise with systems-level thinking and leadership in a regulated environment.

Responsibilities

• Hardware & System Development – Lead the creation of complex hardware platforms, including mechanical assemblies, electrical subsystems, and electromechanical components.
• Oversee design efforts spanning precision mechanisms, materials selection, PCB development, power management, and sensor integration.
• Ensure hardware solutions meet demanding performance, reliability, and safety expectations.
• Define and drive system-level architecture for integrated surgical navigation hardware.
• Ensure seamless interaction between mechanical, electrical, software, and clinical components.
• Manage system requirements, risk analysis, and verification/validation processes across the product lifecycle.
• Recruit, develop, and mentor a high-performing team of hardware and systems engineers.
• Promote a culture of innovation, accountability, collaboration, and high-quality engineering execution.
• Maintain alignment with timelines, budgets, and quality objectives in a regulated environment.

• Process Excellence & Compliance – Implement rigorous systems engineering methodologies including requirements traceability, design controls, and documentation best practices.
• Ensure alignment with medical device standards such as ISO 13485 and IEC 60601.
• Support the transition of designs from R&D through manufacturing under established regulatory guidelines.

• Innovation & Technical Advancement – Identify emerging technologies that can influence or enhance future product roadmaps.
• Lead prototyping, feasibility studies, and early-stage evaluations of new navigation and sensing technologies.
• Encourage intellectual property development and continuous technical improvement.

Qualifications

• Master’s degree or PhD in Mechanical Engineering, Electrical Engineering, or a related field.
• 8+ years of experience in systems or hardware engineering with strong mechanical and electrical foundations.
• 3+ years of leadership experience within regulated industries (medical device experience preferred).
• Expertise in mechanical design (CAD, tolerance analysis, materials) and electrical design (schematics, PCB layout, power systems).
• Strong background in system integration, architecture, and full lifecycle development.
• Experience with medical devices, navigation systems, imaging, robotics, sensing, or real-time control technologies is a plus.
• Knowledge of regulatory frameworks including FDA requirements, IEC 60601, and risk management practices.
• Exceptional communication, leadership, and cross-functional collaboration skills.