ZipRecruiter

Log In

1

Embedded System Validation Engineer Jobs in Massachusetts

Syner-G

Validation Engineer

Boston, MA · On-site +1

The Validation Engineer will be responsible for driving overall quality performance and compliance ... Expertise in Process Equipment, Utilities, Clean Room, and/or Computer Systems validation. * Hands ...

Syner-G

Validation Engineer

Waltham, MA

The Validation Engineer will play a key role in supporting operational readiness, tech transfer ... Perform P&ID walkdowns to verify installation and system readiness. * Conduct thermal mapping of ...

Syner-G

Validation Engineer

Boston, MA · On-site

The Validation Engineer will be responsible for driving overall quality performance and compliance ... Expertise in Process Equipment, Utilities, Clean Room, and/or Computer Systems validation. * Hands ...

Syner-G

Validation Engineer

Boston, MA · On-site

The Validation Engineer will be responsible for driving overall quality performance and compliance ... Expertise in Process Equipment, Utilities, Clean Room, and/or Computer Systems validation. * Hands ...

Trelleborg

Software Validation Engineer

Northborough, MA · On-site

$95K - $105K/yr

... LIMS, labeling systems, statistical analysis software, manufacturing equipment with embedded ... Engineering, or similar disciplines * 3+ years of experience in CSV, software validation, or ...

Valspec

Validation Engineer (CQV)

Boston, MA

Valspec--a global provider of system validation and lifecycle services--provides commissioning and ... Validation Engineer (CQV) Location: Raleigh-Durham area, NC Position Overview We are seeking an ...

Intellectt INC

Validation Engineer

Boston, MA · On-site

Validation Engineer Location: Boston, MA Overview This engagement supports a large-scale Quality Management System (QMS) remediation for a medical device organization under FDA oversight. The ...

next page

Showing results 1-20

All JobsEmbedded System Validation Engineer JobsEmbedded System Validation Engineer Jobs in Massachusetts

Embedded System Validation Engineer information

What is the difference between Embedded System Validation Engineer vs Firmware Test Engineer?

AspectEmbedded System Validation EngineerFirmware Test Engineer
CredentialsBachelor's in Electrical, Computer Engineering, or related; certifications like ISTQB are commonBachelor's in Computer Science, Electrical Engineering; similar certifications often used
Work EnvironmentHardware and software testing in embedded systems, often in labs or manufacturingSoftware testing of firmware, mainly in development or testing labs
Industry UsageAutomotive, consumer electronics, industrial automationConsumer electronics, IoT devices, embedded systems
Common Search/ComparisonYesYes

The Embedded System Validation Engineer focuses on validating both hardware and software components of embedded systems, ensuring overall system functionality. In contrast, the Firmware Test Engineer primarily tests the firmware or software running on embedded devices. While both roles require similar technical skills and certifications, their focus areas differ: validation of entire systems versus software-specific testing.

What are Embedded System Validation Engineers?

Embedded System Validation Engineers are professionals responsible for testing and verifying that embedded systems—specialized computing systems within larger devices—function correctly and meet design specifications. They develop and execute validation plans, create test cases, and use debugging tools to identify hardware and software issues. Their work ensures the reliability, safety, and performance of products such as automotive systems, medical devices, and consumer electronics. Collaboration with design and development teams is crucial to address any detected issues before product release.

What are some common challenges faced by Embedded System Validation Engineers during product testing?

Embedded System Validation Engineers often encounter challenges such as debugging complex hardware-software interactions, managing limited access to prototypes, and ensuring thorough test coverage across various hardware configurations. Collaborating closely with firmware developers and hardware designers is essential to identify and resolve issues efficiently. Additionally, staying updated with new validation tools and methodologies can be necessary to address evolving technology and product requirements.

What are the key skills and qualifications needed to thrive as an Embedded System Validation Engineer, and why are they important?

To excel as an Embedded System Validation Engineer, a strong background in embedded systems, electronics, and programming languages like C/C++ is essential, typically supported by a degree in electrical engineering or a related field. Familiarity with validation tools, oscilloscopes, logic analyzers, version control systems, and test automation frameworks is commonly required. Analytical thinking, problem-solving, and effective communication are vital soft skills for diagnosing complex issues and collaborating with cross-functional teams. These abilities ensure comprehensive system validation, high product quality, and successful integration in complex hardware-software environments.
What are popular job titles related to Embedded System Validation Engineer jobs in Massachusetts? For Embedded System Validation Engineer jobs in Massachusetts, the most frequently searched job titles are:
What job categories do people searching Embedded System Validation Engineer jobs in Massachusetts look for? The top searched job categories for Embedded System Validation Engineer jobs in Massachusetts are:
What cities in Massachusetts are hiring for Embedded System Validation Engineer jobs? Cities in Massachusetts with the most Embedded System Validation Engineer job openings:
Embedded System Validation Engineer jobs near you
Validation Engineer III

Validation Engineer III

Barry-Wehmiller Companies

Boston, MA • On-site

Full-time

Re-posted 4 days ago

Job description

About Us:
BW Design Group is a fully integrated architecture, engineering, construction, system integration, and consulting firm committed to helping our clients realize their most critical goals from Strategy to Commercialization. As the only firm born from a manufacturing technology company to become an independent and fully integrated firm, we combine deep domain expertise in the manufacturing environment with an approach that is built to serve the dynamic needs of our clients. Rooted in our distinct culture of Truly Human Leadership, we cultivate the leaders who will define tomorrow and partner with our clients in the food & beverage, life sciences, industrial, and advanced technology industries to build the future of manufacturing and technology.
Barry-Wehmiller is a diversified global supplier of engineering consulting and manufacturing technology for the packaging, corrugating, sheeting and paper-converting industries. By blending people-centric leadership with disciplined operational strategies and purpose-driven growth, Barry-Wehmiller has become a $3 billion organization with nearly 12,000 team members united by a common belief: to use the power of business to build a better world.
Job Description:
Job Description:
Job Summary
The Validation Engineer III will serve as a key member of the validation team, providing expert-level support to ensure facility equipment, utilities, processes, instrumentation, and computerized systems are qualified and maintained in a validated state in compliance with applicable regulatory requirements. This role functions as a Validation Subject Matter Expert (SME) responsible for leading validation activities, authoring protocols and reports, and providing technical guidance to cross-functional teams. The Validation Engineer III will coordinate and execute qualification activities while collaborating with internal stakeholders and external vendors to support ongoing operations and capital projects.
Key Responsibilities
Validation Documentation & Execution
  • Author, review, and approve validation protocols, reports, and associated documentation including acceptance criteria development
  • Establish, revise, and maintain validation master plans, procedures, and lifecycle documentation for qualification of equipment, systems, and processes in accordance with cGMP requirements
  • Execute and oversee IQ/OQ/PQ protocols for equipment, utilities, and systems
  • Review and complete documentation in accordance with cGMP, ALCOA+ principles, and data integrity requirements
Project & Program Management
  • Lead and manage validation-related project activities including scheduling, resource coordination, protocol execution, and report review
  • Manage external vendors and contractors performing qualification activities
  • Serve as a key member of project teams for design, procurement, installation, and commissioning of new equipment and facility expansion projects
  • Develop and maintain validation project timelines and deliverables
Compliance & Change Control
  • Review proposed changes to validated systems and provide impact assessments
  • Identify validation requirements necessary to maintain systems in a validated state following change implementation
  • Manage periodic requalification activities to ensure equipment, utilities, and processes remain compliant
  • Support equipment and building monitoring systems compliance and updates
Technical Expertise
  • Serve as Subject Matter Expert (SME) in one or more of the following disciplines:
    • Process Mapping
    • Quality Management (Quality Risk Assessments; Change Controls; Deviations; CAPA; Documentation)
    • Equipment qualification (autoclaves, controlled temperature units, filling equipment)
    • Cleaning validation Aseptic process simulation (media fills)
    • Computer system validation (CSV)
    • Process validation Utility qualification (WFI, purified water, clean steam, HVAC)
    • Environmental monitoring systems
  • Provide technical guidance and troubleshooting support for equipment and system failures
  • Deliver training on validation program elements to junior validation personnel
Quality Systems Support
  • Author and support equipment and process-related deviation investigations and CAPA activities
  • Perform and support risk assessments (FMEA, etc.) and data integrity assessments
  • Support internal audits and regulatory agency inspections
  • Ensure all work is performed in accordance with SOPs, cGMPs, quality standards, and safety procedures
Qualifications
Education
  • Bachelor's degree in Engineering, Life Sciences, or related scientific discipline required
  • Master's degree (MS/MSc) preferred
Experience
  • Minimum 5+ years of professional experience in validation, engineering, or operations within a regulated environment
  • Minimum 4+ years of direct experience in a cGMP pharmaceutical, biotechnology, or medical device manufacturing environment
  • Demonstrated expertise as a Subject Matter Expert (SME) in one or more validation disciplines
  • Experience with GMP utilities (WFI, purified water, clean steam, compressed gases, HVAC) and manufacturing equipment
  • Experience supporting regulatory inspections (FDA, EMA, or equivalent) preferred
  • Capital project experience including equipment design, selection, and commissioning preferred
Skills & Competencies
  • Strong technical writing skills with ability to author clear, compliant documentation
  • Solid working knowledge of cGMP regulations, FDA guidance documents, and industry standards (ISPE, PDA, GAMP)
  • Understanding of GDP requirements and ALCOA+ data integrity principles
  • Excellent communication and interpersonal skills with ability to interface across all organizational levels
  • Strong project management and organizational skills
  • Ability to work independently with minimal supervision while also functioning effectively in a team environment
  • Self-motivated with demonstrated initiative and problem-solving abilities
  • Proficiency in Microsoft Office Suite; experience with electronic validation systems a plus
Working Conditions
  • On-site presence required; may involve work in manufacturing, laboratory, and utility areas
  • Ability to gown into cleanroom environments as required
  • Occasional flexibility in schedule and travel may be needed to support project timelines or production schedules
    #LI-TH1

er will interface with our clients and be responsible for preparing and executing commissioning and qualification documents for a variety of utility, facility, and process equipment.
At Barry-Wehmiller we recognize that people come with a wealth of experience and talent beyond just the technical requirements of a job. If your experience is close to what you see listed here, please still consider applying. We know that our differences often can bring about innovation, excellence and meaningful work-therefore, people from all backgrounds are encouraged to apply to our positions. Please let us know if you require reasonable accommodations during the interview process.
Barry-Wehmiller is an equal opportunity employer. M/F/D/V This organization uses E-Verify.
Applicants may be subject to pre-employment screening which may include drug screening, reference checks, employment verifications, background screening and/or skills assessments.
Company:
Design Group

Apply