Senior Systems Engineer

PerkinElmer; Woburn (MA); On-site; USD 135,000 - 145,000; Full time

Job summary

Covaris, a PerkinElmer Company, is seeking an experienced Systems Engineering professional to lead requirements, risk analysis, and verification plans within a regulated medical-device environment. You will collaborate with QA, R&D, and software/hardware teams to ensure seamless integration of software, electrical, and mechanical components.

The role entails owning system requirements, managing risk processes, and communicating project status across stakeholders.

Qualifications

• Degree in a relevant Engineering or Scientific Discipline (Mechanical, Electrical, Embedded, etc) or equivalent technical experience.
• 8+ years of engineering experience, 5+ of Systems Engineering.
• Proficiency in systems engineering in a regulatory environment.
• Experience with planning and deliverables for requirements, risk, trace, and V&V.

Responsibilities

• Manage risk processes and documentation such as FMEAs, harms and hazards, fault tree analyses.
• Collaborate with QA, Engineering, R&D and other departments to implement Systems Engineering best practices.
• Ensure regulatory compliance and deliver innovative solutions for customers.
• Develop and own system requirements for systems including software, mechanical, electrical, and chemical disciplines.
• Coordinate with software, EE, and ME teams to ensure seamless integration of components with hardware.
• Provide regular project updates and address technical or scheduling challenges.
• Decompose requirements on current and new projects.
• Manage external vendors.
• Must work in a laboratory setting and be able to lift up to 25 lbs.
• Role is on-site; hybrid schedules possible with supervisor approval.

Skills

Strong problem-solving

Excellent communication

Regulatory compliance understanding

Cross-functional collaboration

Project coordination

Education

Engineering or Scientific Degree

Tools

Orcanos

DOORS

ALM/Requirements Management

Python

Job description

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/UL/CSA/EU Regulatory Requirements and ASME & ASTM test standards
• Scripting / programming skills with Python or equivalent desired
• 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
• Six Sigma experience and/or certifications are a plus.

The annual compensation range for this full-time position is $135,000.00 to $145,000.00. The final base pay offered to the successful candidate will be determined by factors including internal equity, work location, as well as individual qualifications, such as job-related skills, experience, and relevant education or training.

Reasonable Accommodation

Covaris is committed to the spirit and the letter of the Americans with Disabilities Act. All requirements are subject to possible modification to reasonably accommodate otherwise qualified individuals.