Lead Systems Engineer – Medical Devices & MBSE

PerkinElmer; Woburn (MA); On-site; USD 135,000 - 145,000; Full time

Job summary

Covaris, a PerkinElmer Company, is seeking an experienced Systems Engineering professional to lead requirements, risk analysis, and verification plans within a regulated medical-device environment. You will collaborate with QA, R&D, and software/hardware teams to ensure seamless integration of software, electrical, and mechanical components.

The role entails owning system requirements, managing risk processes, and communicating project status across stakeholders.

Qualifications

• Degree in a relevant Engineering or Scientific Discipline (Mechanical, Electrical, Embedded, etc) or equivalent technical experience.
• 8+ years of engineering experience, 5+ of Systems Engineering.
• Proficiency in systems engineering in a regulatory environment.
• Experience with planning and deliverables for requirements, risk, trace, and V&V.

Responsibilities

• Manage risk processes and documentation such as FMEAs, harms and hazards, fault tree analyses.
• Collaborate with QA, Engineering, R&D and other departments to implement Systems Engineering best practices.
• Ensure regulatory compliance and deliver innovative solutions for customers.
• Develop and own system requirements for systems including software, mechanical, electrical, and chemical disciplines.
• Coordinate with software, EE, and ME teams to ensure seamless integration of components with hardware.
• Provide regular project updates and address technical or scheduling challenges.
• Decompose requirements on current and new projects.
• Manage external vendors.
• Must work in a laboratory setting and be able to lift up to 25 lbs.
• Role is on-site; hybrid schedules possible with supervisor approval.

Skills

Strong problem-solving

Excellent communication

Regulatory compliance understanding

Cross-functional collaboration

Project coordination

Education

Engineering or Scientific Degree

Tools

Orcanos

DOORS

ALM/Requirements Management

Python

Job description

Covaris, a PerkinElmer Company, is seeking an experienced Systems Engineering professional to lead requirements, risk analysis, and verification plans within a regulated medical-device environment. You will collaborate with QA, R&D, and software/hardware teams to ensure seamless integration of software, electrical, and mechanical components.

The role entails owning system requirements, managing risk processes, and communicating project status across stakeholders.