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Principal Systems Engineer
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Job DescriptionJob Description
EHR Services has partnered with Covaris, LLC to hire a Principal Systems Engineer.
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.
Essential 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 25 lbs.
This is predominantly an on-site position. Occasional remote work is OK with supervisor approval.
Required 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.
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 .
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.
Skills and Background:
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
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.
Covaris, LLC. (www.covaris.com) is a profitable technology company headquartered in Woburn, Massachusetts, USA. Covaris has developed a proprietary and patented Adaptive Focused Acoustics™ (AFA) technology platform, which is utilized in sample preparation processes in the analytical and life sciences industries worldwide. Covaris AFA has become the gold standard for DNA fragmentation in the Next Sequencing market. Covaris AFA is used by the largest and most productive genome centers worldwide.
Job Posted by ApplicantPro
EHR Services has partnered with Covaris, LLC to hire a Principal Systems Engineer.
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.
Essential 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 25 lbs.
This is predominantly an on-site position. Occasional remote work is OK with supervisor approval.
Required 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.
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 .
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.
Skills and Background:
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
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.
Covaris, LLC. (www.covaris.com) is a profitable technology company headquartered in Woburn, Massachusetts, USA. Covaris has developed a proprietary and patented Adaptive Focused Acoustics™ (AFA) technology platform, which is utilized in sample preparation processes in the analytical and life sciences industries worldwide. Covaris AFA has become the gold standard for DNA fragmentation in the Next Sequencing market. Covaris AFA is used by the largest and most productive genome centers worldwide.
Job Posted by ApplicantPro