Systems Engineer III

Werfen – Bedford – 180 Hartwell Road Bedford, Massachusetts 01730, United States

The Engineer III will be an individual contributor to support systems engineering programs related to software within a regulated medical device environment. This person will serve as a hands‑on technical aid across software related system investigations, root cause analysis, risk assessments, design changes, and product support activities. This is not a people‑management role. The right candidate will execute technical work streams and programs tied to software‑driven systems, working closely with software, hardware, systems, quality, manufacturing, and regulatory teams to troubleshoot complex issues and drive deliverables to closure.

The annual base salary range for this role is currently $90,000 to $120,000. Compensation will be based on education, experience, skill set, knowledge, and business needs.

This role is eligible for medical, dental, and vision insurance, a 401(k) plan with employer match, and paid vacation and sick leave.

• Execute software and systems engineering work streams tied to investigations, root cause analysis, risk assessments, design changes, and product support activities.
• Troubleshoot software‑driven system issues across software, hardware, firmware, electrical components, boards, interfaces, configurations, workflows, and integrated product platforms.
• Support investigations for product defects, field issues, manufacturing issues, complaints, CAPAs, system failures, and performance concerns.
• Assess the technical impact of component swaps, board swaps, software changes, firmware updates, configuration changes, and system modifications.
• Review technical data, logs, test results, trends, and investigation outputs to help determine root cause, risk, and next steps.
• Document investigation findings, technical rationale, impact assessments, risk evaluations, and recommended corrective actions.
• Support design control activities, including technical documentation, specifications, test plans, protocols, reports, traceability, and risk documentation.
• Partner cross‑functionally with systems, software, hardware, electrical, quality, manufacturing, regulatory, and operations teams to resolve technical issues.
• Lead or support development of test methods, troubleshooting approaches, technical processes, specifications, and system‑level verification activities.
• Coordinate technical inputs across functions to keep programs, investigations, and deliverables moving.
• Communicate technical issues clearly through documentation, presentations, technical summaries, and team discussions.
• Recommend and support process improvements related to investigations, root cause analysis, software/system troubleshooting, risk management, and design control practices.

• Bachelor's degree in Engineering, Science, or a related field.
• 5 years of relevant experience in software engineering, systems engineering, product development, sustaining engineering, or a similar technical role.
• 1–3 years of product development or relevant experience for advanced degrees.
• In vitro medical device experience highly desired.
• Proficiency in English language.
• Experience in a regulated medical device, in vitro diagnostics, life sciences, or a similarly regulated environment.
• Strong background in software‑driven systems, system‑level troubleshooting, root cause analysis, and technical investigations.
• Ability to evaluate issues across software, hardware, firmware, electrical, board, component, and system interfaces.
• Experience with risk management, impact assessments, product changes, design changes, and design control documentation.
• Experience supporting CAPA, complaints, product defects, or post‑market investigations.
• Strong cross‑functional communication skills with the ability to explain technical issues clearly to technical and non‑technical stakeholders.
• Travel:
  Some domestic and international travel may be required.
• International mobility:
  Not required.

Werfen is an Equal Opportunity employer and is committed to a diverse workplace. Werfen strictly prohibits unlawful discrimination, harassment or retaliation based upon an individual’s race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other protected characteristic as defined by applicable state or federal law. If you have a disability and need an accommodation in relation to the online application process, please contact N for assistance.