Systems Engineer

Jobtailor; New Kensington (Westmoreland County); On-site; USD 120,000 - 160,000; Full time

Job summary

Jobtailor is seeking a senior Systems Engineer to conduct deep analyses, drive design decisions, and lead cross-functional initiatives in medical device development. You will mentor engineers, translate complex standards into actionable requirements, and ensure compliance through DHF and Risk Management File practices.

Ideal candidates have extensive experience with NPD, FMEA, and end-to-end product lifecycle, delivering robust, compliant systems across hardware and software domains.

Qualifications

• Bachelor’s or Master’s in engineering or related field required.
• Minimum 5 years (Bachelor’s) or 3 years (Master’s) in systems engineering or hardware/software co-design.
• Certified Systems Engineering Professional (CSEP) preferred.
• Experience with NPD and full product life cycle strongly preferred.

Responsibilities

• Conduct in-depth system analyses and performance assessments with modeling and simulation.
• Inform system design decisions and drive continuous improvement in systems engineering.
• Bridge R&D, manufacturing and regulatory teams to align requirements and standards.
• Review design artifacts for compliance with systems engineering principles and regulations.
• Lead comprehensive systems engineering strategies aligned with objectives and standards.
• Mentor junior engineers and grow systems engineering expertise.
• Analyze requirements and generate detailed specifications for performance.
• Develop and pilot advanced systems engineering methodologies and tools.
• Serve as senior technical authority for complex engineering challenges.
• Lead cross-functional process enhancements using lean methods to boost productivity.
• Write Product and Element Requirements with rationales.
• Interpret IEC 60601-1-11, ISO 80601-2-70, ISO 80601-2-72 standards.
• Lead deep-dive FMEA and drive findings into subsystem requirements.
• Ensure control measures feed into Risk Management File and DHF for audits.
• Define how system risks drive software, electrical and mechanical requirements.
• Develop verification and validation protocols and test plans.
• Create V-model traceability across projects.
• Develop technical reviews to align cross-functional teams.

Skills

Systems engineering

Medical device standards

FMEA

Risk management

Cross-functional leadership

Documentation

Education

Bachelor’s / Master’s degree in electrical/electronic/mechanical engineering or computer science

Tools

V-model

Trace matrices

Risk management tooling

Job description

Responsibilities

• Conducts in-depth system analyses and performance assessments, leveraging advanced modeling and simulation techniques to identify optimization opportunities and mitigate risks, working under limited supervision.
• Synthesizes insights from cutting‑edge research and industry trends to inform system design decisions and drive continuous improvement initiatives within the systems engineering domain.
• Acts as a bridge between various functional teams, including R&D, manufacturing, and regulatory affairs, facilitating effective communication and alignment on systems engineering requirements and standards.
• Reviews and assesses system documentation and design artifacts with rigorous attention to detail, verifying compliance with established systems engineering principles and industry regulations.
• Leads the formulation and execution of comprehensive systems engineering strategies, ensuring alignment with organizational objectives and industry standards.
• Mentors and guides junior systems engineers, imparting specialized knowledge and fostering their growth in systems engineering principles and methodologies.
• Analyzes system requirements and generates detailed design specifications, employing advanced systems engineering techniques to optimize system performance and reliability.
• Innovates and pilots novel systems engineering methodologies and tools, aiming to enhance efficiency, quality, and agility in system development processes.
• Serves as a senior technical authority and escalation point for intricate systems engineering challenges, providing expert guidance and problem‑solving expertise.
• Leads cross‑functional initiatives to develop and implement process enhancements within the systems engineering framework, leveraging lean methodologies to optimize workflows and maximize productivity.
• Writes Product and Element Requirements along with their rationales.
• Interprets and decomposes medical device standards such as IEC 60601‑1‑11, ISO 80601‑2‑70, and ISO 80601‑2‑72.
• Leads deep‑dive FMEA (Failure Mode and Effects Analysis); evaluates full and partial failure of requirements and drives findings into specific subsystem requirements to mitigate risks.
• Ensures all control measures feed directly into the Risk Management File and the Design History File (DHF), maintaining a submission‑ready audit trail through the NPD sprint.
• Defines how system‑level risks drive specific requirements into software, electrical, and mechanical subsystems to ensure essential performance.
• Develops V&V protocols and test plans as needed.
• Develops trace matrices across and up and down the V‑model.
• Develops technical reviews to align cross‑functional teams on the direction.

Requirements

• Minimum required Education: Bachelor’s / Master’s degree in electrical engineering, electronic engineering, mechanical engineering, computer science engineering or equivalent.
• Minimum required Experience: Minimum 5 years of experience with a Bachelor’s degree or minimum 3 years of experience with a Master’s degree in areas such as system architecture, system design, hardware engineering or equivalent.
• Preferred Certification: Certified Systems Engineering Professional (CSEP).
• Significant experience in New Product Development (NPD) and can speak to experience through the full product life cycle.
• Expertise developing electromechanical devices with hardware and software elements.
• Deep understanding of medical device standards such as ISO 14971 and the 60601 series.