Systems Engineer

Real; Boston (OH); Hybrid; USD 96,000 - 152,000; Full time

Job summary

Specialist Staffing Group is seeking a senior Systems Engineer to support digital surgery and navigation initiatives in a regulated medical device environment. This hybrid, Boston-based role focuses on concept development, requirements definition, and early-stage research in orthopedic surgery technology.

The successful candidate will lead cross-functional teams, drive risk management, and ensure design controls, verification and validation plans align with medical device standards from concept

Qualifications

• Bachelor's degree in Engineering or related technical field.
• 7+ years of Systems Engineering in regulated product development.
• Experience as Senior/Principal/Staff Systems Engineer.
• Experience with surgical navigation, digital surgery, robotics, imaging, or related medical devices.

Responsibilities

• Lead systems engineering activities for early-stage technology and product development initiatives.
• Develop and manage system requirements, specifications, and traceability.
• Conduct system-level analysis, architecture development, and technical evaluations.
• Perform risk management per medical device development processes.
• Support proof-of-concept development and technology feasibility assessments.
• Collaborate with software, hardware, mechanical, robotics, imaging, and clinical stakeholders.
• Ensure adherence to medical device standards and design controls.
• Contribute to system verification and validation planning.
• Drive technical problem-solving and provide engineering leadership.

Skills

Systems engineering

Requirements development

Risk management

Concept development

Independent work

Cross-functional collaboration

Communication

Education

Bachelor's degree in Engineering

Job description

Duration: 12-Month Contract (Extension Potential)

Start Date: ASAP / Mid-October Target

About the Opportunity

Systems Engineer (Digital Surgery / Navigation)

Location: Hybrid (Boston, MA)

We are seeking an experienced Systems Engineer to support an innovative research and development initiative focused on next-generation technologies in the orthopedic surgery space. This role will contribute to early-stage technology exploration, proof-of-concept development, and systems engineering activities supporting digital surgery and navigation-related solutions.

The successful candidate will work in a highly collaborative R&D environment and help drive the development of emerging technologies from concept through technical evaluation.

Position Summary

We are looking for a senior-level Systems Engineer with experience in digital surgery, surgical navigation, robotics, imaging, or related medical device technologies. The ideal candidate will bring a strong systems engineering background, experience working within regulated medical device environments, and the ability to independently drive concept development and technical investigations.

This individual will work across multidisciplinary teams to define system requirements, assess technical risks, and support the development of innovative medical technologies from concept through evaluation.

Key Responsibilities

• Lead systems engineering activities for early-stage technology and product development initiatives.
• Develop and manage system requirements, specifications, and traceability documentation.
• Conduct system-level analysis, architecture development, and technical evaluations.
• Perform risk management activities in accordance with medical device development processes.
• Support proof-of-concept development and technology feasibility assessments.
• Collaborate with software, hardware, mechanical, robotics, imaging, and clinical stakeholders.
• Ensure adherence to applicable medical device standards and design control requirements.
• Contribute to system verification and validation planning activities.
• Drive technical problem-solving efforts and provide independent engineering leadership.

Required Qualifications

• Bachelor's degree in Engineering or a related technical discipline.
• Minimum 7+ years of Systems Engineering experience within a regulated product development environment.
• Prior experience operating at a Senior, Principal, or Staff Systems Engineer level.
• Experience with surgical navigation systems, digital surgery platforms, robotics, imaging technologies, or related medical device systems.
• Strong background in:
  • Systems engineering methodologies
  • Requirements development and management
  • Risk management
  • Technology development and proof-of-concept activities
  • Medical device standards and design controls
• Ability to work independently with minimal oversight.
• Strong communication and cross-functional collaboration skills.

Preferred Qualifications

• Experience supporting orthopedic surgery technologies, particularly joint reconstruction applications.
• Familiarity with navigation systems used in knee, hip, or other orthopedic procedures.
• Experience with robotic-assisted surgical systems.
• Background in medical imaging technologies and image-guided procedures.
• Understanding of digital health, connected medical devices, or software-enabled surgical platforms.

Top Priority Experience

Candidates will be strongest if they possess:

• Systems Engineering expertise within medical devices.
• Medical device standards, requirements development, and risk management experience.
• Technology development experience, including proof-of-concept and early-stage R&D initiatives.
• Surgical navigation, robotics, imaging, or digital surgery experience.

This role is ideal for a self-driven Systems Engineer who enjoys working in a fast-paced innovation environment and helping shape the future of digital and robotic-assisted surgical technologies.

EOE Statement: Specialist Staffing Group is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.