Senior Systems Engineer
About The Position
Covaris, a PerkinElmer Company, is seeking a Systems Engineering professional to apply advanced scientific and systems engineering knowledge to complex assignments, working with guidance from project and management teams. The Senior Systems Engineer will lead and own requirements, trace matrices, and engineering risks; participate in system integration; and contribute to verification plans and testing. The role works across engineering and scientific disciplines and collaborates with quality, R&D, software, electrical, mechanical, and other teams to deliver compliant, innovative customer solutions. The position is based at Covaris in Woburn, Massachusetts, and requires on-site availability. Hybrid schedules may be possible with supervisor approval when the work does not require physical presence. The role involves working in a laboratory setting and lifting objects weighing up to 25 pounds.
Requirements
- Degree in a relevant engineering or scientific discipline, such as mechanical, electrical, embedded, or systems engineering; a closely related discipline or equivalent technical experience with demonstrated competence is also acceptable.
- At least 8 years of engineering experience, including at least 5 years of Systems Engineering experience.
- Demonstrated proficiency in Systems Engineering, specifically in a regulatory environment.
- Experience planning and delivering requirements, risk, traceability, and verification and validation (V&V) work.
- 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 ISO 13485.
- Experience with Orcanos, DOORS, or a similar ALM/requirements management system.
- Strong problem-solving skills and ability to break down and solve complex problems using structured tools.
- Expertise with Microsoft Office, including Word, Excel, PowerPoint, Teams, and Outlook.
- Excellent written, verbal, and presentation communication skills.
- Ability to work in a laboratory setting and lift objects weighing up to 25 pounds.
- On-site availability is required; hybrid schedules are possible with supervisor approval when work does not require physical presence.
Nice To Haves
- 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, or other single-source-of-truth approaches.
- Test design and execution experience, preferably with automation.
- Risk management ability, including identifying technical risks and developing effective mitigations.
- Scripting or programming for data analysis, prototype automation, or test execution.
- Familiarity with CE, UL, CSA, and EU regulatory requirements and ASME and ASTM test standards.
- Python or equivalent scripting or programming skills.
- Exposure to biotechnology or bioengineering, including familiarity with common instrumentation such as NGS, PCR, RT-PCR, and DNA sequencers; genomics, DNA sequencing, proteomics, and epigenomics workflows; and processes such as sample preparation and purification, enzymatic fragmentation, and lysing.
- Six Sigma experience and/or certifications.
Responsibilities
- Conduct and contribute to risk processes, documentation, and management, including FMEAs, harms and hazards, and fault tree analyses.
- Work with QA, Engineering, 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 customer solutions.
- Develop and own system requirements and the elicitation process for systems involving software, mechanical, electrical, chemical, and bioanalytical disciplines.
- Collaborate with software development, electrical engineering, and mechanical engineering teams to integrate software and firmware components with hardware systems, following software engineering best practices 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.
- Participate in system integration, verification planning, and testing.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
