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PerkinElmer

Analytical instruments and software for health

Senior Systems Engineer

Biomedical Engineering & Medical DevicesConfirmed live in the last 24 hours
Full-timeBurlington, MA, USA$135k - $145k /yr

About the Job

Requirements

  • A degree in a relevant engineering or scientific discipline, including mechanical, electrical, embedded, or systems engineering, a closely related discipline, or equivalent technical experience plus demonstrated competence.
  • At least 8 years of engineering experience, including at least 5 years of systems engineering experience.
  • Demonstrated proficiency in systems engineering in a regulatory environment.
  • Experience planning and delivering requirements, risk, traceability, and verification and validation work.
  • Experience with instrumentation and complex systems.
  • Experience with FDA Class I or higher medical devices.
  • Experience with Quality Control processes, electronic Quality Management Systems, and ISO 9001 and ISO 13485.
  • Experience with Orcanos, DOORS, or a similar application lifecycle management or requirements management system.
  • Expertise with Microsoft Office, including Word, Excel, PowerPoint, Teams, and Outlook.
  • Ability to work in a laboratory setting and lift objects weighing up to 25 pounds.

Responsibilities

  • Conduct and contribute to risk processes, documentation, and management, including Failure Modes and Effects Analyses, harms and hazards analyses, and fault tree analyses.
  • Work with Quality Assurance, Engineering, Research and Development, 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 requirements 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 components with hardware systems in accordance with software engineering best practices and medical device software standards.
  • Facilitate communication between teams and stakeholders, provide regular project updates, and address technical or scheduling challenges.
  • Perform requirements decomposition on current and new projects.
  • Manage external vendors.

Desired Qualifications

  • Translate biological assay targets and analytical metrics into meaningful system requirements.
  • Have a general understanding across engineering disciplines.
  • Have experience with data-driven development using model-based systems engineering, model-based engineering, databases, or single-source-of-truth approaches.
  • Have preferred experience designing and executing tests with automation.
  • Identify technical risks and develop effective mitigations.
  • Use scripting or programming for data analysis, prototype automation, or test execution.
  • Be familiar with CE, UL, CSA, and EU regulatory requirements, and ASME and ASTM test standards.
  • Have scripting or programming skills, preferably Python or an equivalent language.
  • Have exposure to biotechnology or bioengineering, including familiarity with common instrumentation such as next-generation sequencing, PCR, reverse-transcription PCR, and DNA sequencers; workflows such as genomics, DNA sequencing, proteomics, and epigenomics; and processes such as sample preparation and purification, enzymatic fragmentation, and lysing.
  • Have Six Sigma experience or certifications.

About the Company

PerkinElmer

Analytical instruments and software for health

PerkinElmer provides analytical instruments, software, and services for the life sciences, diagnostics, and environmental health markets. Customers use these tools to collect and analyze data through a combination of hardware, consumable supplies, and software licensing. Unlike many competitors, the company integrates a global service network with a focus on sustainability by designing products that reduce waste and energy consumption. Its goal is to improve human and environmental health by helping laboratories and industrial companies achieve more efficient and accurate scientific results.

Company size
5,001-10,000
Company stage
IPO
Headquarters
Shelton, CT
Founded
1937

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