Senior Systems Engineer REQ-058800

Covaris, a PerkinElmer Company, is aleader in sample preparation solutions across multiomics research and clinical applications.Powered by proprietary Adaptive Focused Acoustics (AFA) technology, our portfolio ofadvanced instruments, consumables, reagents, and kits for pre-analytical sample preparation deliver exceptionalaccuracy and reproducibility, enabling researchers to generate higher-quality data, develop novel assays, and drive breakthrough discoveries in life sciences. From academic labs to global biopharma organizations, Covaris is trusted by scientists who demand precision at every step of the analytical workflow. Learn more at www.covaris.com.

Covaris is moving! This position will be located at the new headquarters in Burlington, MA.

Summary

Covaris is seeking a Systems Engineering professional who, working with guidance from the project and management, applies advanced scientific knowledge, systems engineering knowledge, and ingenuity to complete complex assignments. This person will be expected to lead and own requirements, trace matrices, and engineering risks; participate in integration; and be a key player in verification plans and testing.

Responsibilities

Conduct and contribute to risk processes, documentation, and management Including FMEAs, harms and hazards, fault tree analyses, etc. Work with QA, the Engineering team, R&D and other innovation and technology departments to implement and champion Systems Engineering best practices. Collaborate on cross-functional efforts, ensuring regulatory compliance and delivering innovative solutions for customers. Develop and own system requirements and the elicitation process for systems including software, mechanical, electrical, and chemical, bioanalytical disciplines. Collaborate closely with software development, EE, and ME teams to ensure seamless integration of software/firmware components with hardware systems, adhering to best practices in software engineering and medical device software standards. Facilitate transparent communication between teams and stakeholders, provide regular project updates and address technical or scheduling challenges. Perform requirement decomposition on current and new projects. Manage external vendors. Must be able to work in a laboratory setting and lift objects as heavy as 25lbs. This role requires on-site availability. Hybrid schedules are possible with supervisor approval when work does not require physical presence.

Qualifications

Degree in a relevant Engineering or Scientific Discipline (Mechanical, Electrical, Embedded, etc), Systems Engineering, closely related discipline, or equivalent technical experience plus demonstrated competence. 8+ years of engineering experience, 5+ of Systems Engineering. Demonstrated proficiency of systems engineering, specifically in a regulatory environment. Experience with planning and deliverables for requirements, risk, trace, and V&V. Experience with instrumentation and complex systems. Experience with FDA Class I or greater medical devices. Experience with Quality Control processes, eQMSs, and ISO 9001 and 13485 Experience with Orcanos, DOORS, or similar ALM/Requirements Management system Strong problem-solving skills - able to break down and solve complex problems with structured tools. Expertise with Microsoft Office - Word, Excel, PowerPoint, Teams, Outlook. Excellent communication skills - written, verbal, and presentation skills.

Desired Skills and Background:

Ability to translate biological assay targets and analytical metrics into meaningful system requirements General understanding across engineering disciplines Experience with data driven development through MBSE, MBE, databases, etc. ("single source of truth" approaches) Test design and execution with automation experience preferred. Risk Management - Ability to identify technical risks & develop effective mitigations Scripting or programming data analyses, prototype automation, test execution, etc. Familiarity with CE