When joining PerkinElmer, you select an experienced and trusted leader in scientific solutions, with the support of a global service network and distribution centers, providing the right solution, at the right time, to meet critical customer needs. With over an 80+ year legacy of advancing science and a mission of innovating for a healthier world, our dedicated team collaborates closely with commercial, government, academic and healthcare customers to deliver our broad portfolio of analytical solutions, and OneSource services.
Job Title
Senior Systems Engineer
Location(s)
Covaris - Woburn - MA
Job Description
Covaris, a PerkinElmer Company , is a leader in sample preparation solutions across multiomics research and clinical applications. Powered by proprietary Adaptive Focused Acoustics® (AFA®) technology, our portfolio of advanced instruments, consumables, reagents, and kits for pre-analytical sample preparation deliver exceptional accuracy 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 .
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…