Principal Systems Engineer

Covaris, LLC., a PerkinElmer company, is a profitable and rapidly growing technology company headquartered in Woburn, Massachusetts.Covaris developed the proprietary and patented Adaptive Focused Acoustics™ (AFA) technology platform, holding a leadership position in sample preparation for DNA sequencing and providing significant benefits to drug delivery and formulation development. For more information, visit Covaris technological foundation is based on its proprietary and patented Adaptive Focused Acoustics™ (AFA) technology. AFA enables a vast array of non-contact, isothermal processes to be developed for various applications in genomics, proteomics, cell biology, drug discovery, and formulation. Thousands of Covaris-Focused Ultrasonicators are used in over 30 countries. Customers include the world’s leading researchers, universities, and pharmaceutical companies. Covaris continues to innovate pre-analytical sample preparation technologies to accelerate the pace of research and drug discovery. Summary Covaris is seeking a Principal Systems Engineer who can work independently, applying advanced scientific and systems engineering expertise, mathematics, and ingenuity to solve complex challenges. This role requires leading and owning system requirements, traceability matrices, and engineering risk assessments, actively participating in system integration, and playing a key role in verification planning and testing. The ideal candidate will ensure compliance with best practices while driving innovation and reliability in system performance. This is predominantly an on-site position located in Woburn, MA. Occasional remote work is OK with supervisor approval. 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, 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 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, providing regular project updates and addressing technical or scheduling challenges.
• Perform requirement decomposition on of current and new projects.
• Manage external vendors.
• Must be able to work in a laboratory setting and lift objects as heavy as 25lbs.

• Degree in a relevant Engineering 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.
• Project or Functional Team leadership or direct management experience
• Demonstrated mastery of systems engineering, specifically in a regulatory environment.
• Experience with planning and deliverables for requirements, trace, and V&V.
• Experience with instrumentation and complex systems.
• Exposure to biology, biotechnology, or biopharma.
• Experience with FDA Class I or greater medical devices. IVD class II desired.
• Experience with Quality Control processes, eQMSs, and ISO 9001 and 13485
• Familiarity with CE/UL/CSA/EU Regulatory Requirements and ASME & ASTM test standards
• Experience w/ FMEA, DOE, DFX
• Test design and execution with automation experience preferred.
• Six Sigma experience and/or certifications are a plus.
• 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.
• Scripting / programming skills with Python or equivalent desired

• General understanding across engineering disciplines
• Experience with data driven development through MBSE, MBE, databases, etc. (“single source of truth” approaches)
• SysML v2 familiarity a plus
• “Toolsmith” skills / experience with SE / modeling tool implementation desired.
• Risk Management – Ability to identify technical risks & develop effective mitigations
• Scripting or programming data analyses, prototype automation, test execution, etc.
• Exposure to biotechnology/bioengineering – familiarity with common instrumentation (NGS, PCR, Rt-PCR, common DNA sequencers, etc.), workflows (end-to-end for genomics, DNA sequencing, proteomics, epigenomics, etc.), and processes (including sample prep and purification, enzymatic fragmentation, lysing, etc.) is a plus