Senior Systems Engineer

PerkinElmer•Woburn, MA

2d•Hybrid

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 role leads and owns system requirements and trace matrices, manages engineering risks, participates in integration, and contributes to verification plans and testing. The position is based at Covaris’s new headquarters in Burlington, Massachusetts, and requires on-site availability. Hybrid scheduling may be possible with supervisor approval when work does not require physical presence. The role includes working in a laboratory and lifting objects weighing up to 25 pounds.

Requirements

Degree in a relevant engineering or scientific discipline, Systems Engineering, or a closely related discipline, or equivalent technical experience with demonstrated competence.
At least 8 years of engineering experience, including at least 5 years in Systems Engineering.
Demonstrated Systems Engineering proficiency in a regulatory environment.
Experience planning and delivering requirements, risk, traceability, and verification and validation activities.
Experience with instrumentation and complex systems.
Experience with FDA Class I or higher medical devices.
Experience with quality control processes, eQMSs, and ISO 9001 and ISO 13485.
Experience with Orcanos, DOORS, or a similar ALM or requirements management system.
Strong problem-solving skills and the 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.
Availability to work on-site as required and ability to work in a laboratory and lift objects weighing up to 25 pounds.

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 similar single-source-of-truth approaches.
Test design and execution experience, preferably with automation.
Ability to identify technical risks and develop effective mitigations.
Scripting or programming experience 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 instrumentation such as NGS, PCR, RT-PCR, and DNA sequencers; genomics, DNA sequencing, proteomics, and epigenomics workflows; and sample preparation, purification, enzymatic fragmentation, and lysing processes.
Six Sigma experience 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 to ensure regulatory compliance and deliver solutions for customers.
Develop and own system requirements and the elicitation process for systems spanning software, mechanical, electrical, chemical, and bioanalytical disciplines.
Collaborate with software development, electrical engineering, and mechanical engineering teams to integrate software and firmware with hardware systems, following software engineering best practices and medical device software standards.
Facilitate communication between teams and stakeholders, provide project updates, and address technical or scheduling challenges.
Perform requirements decomposition on current and new projects.
Manage external vendors.
Participate in system integration and contribute to verification plans and testing.
Work in a laboratory setting and lift objects weighing up to 25 pounds.