Responsibilities

Company Overview:

Covaris, LLC (a PerkinElmer subsidiary) is a leading sample preparation solution provider in Biotechnology headquartered in Woburn, Massachusetts and has pioneered the Adaptive Focused Acoustics(AFA) technology platform, therebyrevolutionizing pre-analytical sample preparation in the world of Omics, such as genomics, proteomics, etc.

As a global leader in sample preparation technologies for life sciences research and molecular diagnostics applications, Covaris has successfully been awarded the ISO 13485 Quality System Certification. This certification demonstrates our commitment to meeting the highest international standards for medical device quality management systems and ensuring the high quality of life science research data for research and innovation.

Summary

Covaris is seeking a Systems Engineering professional who, working with little or no supervision, applies advanced scientific knowledge, systems engineering knowledge, mathematics, 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 or leader 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, 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.
• This is predominantly an on-site position. Occasional remote work is OK with supervisor approval.

Qualifications:

• 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.

Desired Skills and Background:

• 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