Lead, Hardware Systems Engineering (Medical Devices)

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

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.