System Design Engineer

The Systems Design Engineer supports the design, development, and implementation of medical device systems and software by applying systems engineering principles throughout the product lifecycle. This role focuses on establishing and maintaining a structured, traceable design control framework using Jama and related tools to ensure compliance, quality, and efficient verification and validation processes.

• Follow the company’s software development lifecycle to design, code, configure, test, debug, and document applications and systems

• Review functional requirements, analysis, and design documents; provide technical feedback and recommendations

• Develop and maintain technical design specifications, architecture documents, and system-level documentation

• Collaborate with cross-functional engineering teams to define system architecture, requirements, and use cases

• Establish a new implant and instrument design control and risk management structure using a systems engineering approach

• Create and maintain requirement hierarchies, traceability matrices, and verification/validation documentation in Jama

• Translate legacy design controls into the new structured system and ensure seamless integration

• Apply systems engineering techniques such as traceability, architecture modeling, trade studies, simulations, and budgeting

• Lead or contribute to design verification efforts and integration of systems into final product solutions

• Participate in design and code reviews to ensure quality and consistency

Minimum Qualifications (Must Have):-

• Bachelor’s degree in Software, Electrical, Mechanical, Systems, or Biomedical Engineering.
• 2 years of experience in Systems Engineering, Requirements Management, or Risk Management roles.
• Demonstrated understanding of requirements hierarchy, traceability, and design control processes.

Preferred Qualifications (Strongly Desired):-

Technical Skills:

• 2 years of Systems Engineering or related experience.
• Hands-on experience with Requirements Management Tools, ideally Jama Connect.
• Strong working knowledge of design controls, risk management, and verification planning.
• Familiarity with architecture modeling and Model-Based Systems Engineering (MBSE) concepts.

Preferred Tools / Experience:

• Jama Connect (strongly preferred).
• Other RM tools (Integrity, DOORS, Polarion, etc.) acceptable.
• SysML / MBSE tools such as Cameo, MagicDraw, or Enterprise Architect.
• Knowledge of ISO 13485, ISO 14971, FDA 21 CFR 820, and related medical device standards.

System One offers eligible employees health and welfare benefits coverage options, including medical, dental, vision, spending accounts, life insurance, voluntary plans, and participation in a 401(k) plan.