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Validation Engineer Biomedical Jobs in Massachusetts

Nova Biomedical

Senior Quality Engineer

Norwood, MA · On-site

$100K - $135K/yr

Maintain and oversee the Nova Biomedical Validation File and Log (a Microsoft Excel file) and the ... Bachelor's degree or higher in Engineering or the technical sciences * 7 plus years Medical Device ...

Nova Biomedical

Senior Quality Engineer

Billerica, MA · On-site

$94K - $127K/yr

The Senior Quality Engineer will provide Quality Engineering support to ensure that quality ... validation activities are appropriate to their needs and in alignment with Nova Biomedical ...

Nova Biomedical

Senior Quality Engineer

Billerica, MA

$94K - $127K/yr

The Senior Quality Engineer will provide Quality Engineering support to ensure that quality ... validation activities are appropriate to their needs and in alignment with Nova Biomedical ...

Nova Biomedical

Senior Quality Engineer

Billerica, MA · On-site

$94K - $127K/yr

The Senior Quality Engineer will provide Quality Engineering support to ensure that quality ... validation activities are appropriate to their needs and in alignment with Nova Biomedical ...

Nova Biomedical

Sr. Automation Control Engineer

Waltham, MA · On-site

$113K - $148K/yr

Author and maintain engineering documents, including URS, FRS, change controls, and test protocols ... Nova Biomedical systems, including J-Drive, I-Drive, and MasterControl. * Deliver validation ...

Nova Biomedical

Senior Quality Engineer

Norwood, MA · On-site

$100K - $135K/yr

Maintain and oversee the Nova Biomedical Validation File and Log (a Microsoft Excel file) and the ... Bachelor's degree or higher in Engineering or the technical sciences * 7 plus years Medical Device ...

Nova Biomedical

Sr. Automation Control Engineer

Waltham, MA · On-site

$112K - $147K/yr

Author and maintain engineering documents, including URS, FRS, change controls, and test protocols ... Nova Biomedical systems, including J-Drive, I-Drive, and MasterControl. * Deliver validation ...

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All JobsValidation Engineer Biomedical JobsValidation Engineer Biomedical Jobs in Massachusetts

Validation Engineer Biomedical information

What is the difference between Validation Engineer Biomedical vs Quality Assurance Engineer Biomedical?

AspectValidation Engineer BiomedicalQuality Assurance Engineer Biomedical
CertificationsGMP, ISO, FDA validation certificationsGMP, ISO, audit and compliance certifications
Work EnvironmentDesign, develop, and execute validation protocols for medical devicesDevelop and maintain quality systems, audits, and process improvements
Industry UsagePrimarily in medical device manufacturing and regulatory validationAcross medical device, pharmaceutical, and biotech industries

Validation Engineer Biomedical focuses on ensuring medical devices meet regulatory validation requirements through testing and protocols. Quality Assurance Engineer Biomedical emphasizes maintaining quality systems, compliance, and process improvements. Both roles are essential in the biomedical industry but serve different functions related to validation versus quality assurance.

What are some typical challenges faced by validation engineers in the biomedical industry and how can they be addressed?

Validation Engineers in the biomedical field often face challenges such as keeping up with evolving regulatory requirements, managing complex documentation, and ensuring equipment or processes meet stringent quality standards. Navigating audits and working cross-functionally with R&D, manufacturing, and quality assurance teams can also be demanding. To address these challenges, staying current with industry regulations, developing strong organizational and communication skills, and maintaining meticulous records are essential for success and career growth in this role.

What are the key skills and qualifications needed to thrive as a validation engineer in biomedical?

To thrive as a Validation Engineer in Biomedical, you need a solid background in engineering or life sciences, knowledge of regulatory standards (such as FDA or ISO 13485), and experience with validation protocols. Familiarity with technical tools like statistical analysis software, calibration equipment, and documentation systems is essential, and certifications such as Six Sigma or CQE can be advantageous. Strong problem-solving, attention to detail, and effective communication skills help you excel in cross-functional teams and ensure compliance. These skills are crucial for maintaining product quality, meeting regulatory requirements, and ensuring patient safety in biomedical environments.

What does a validation engineer do in biomedical?

A Validation Engineer in the biomedical industry ensures that equipment, processes, and systems used in the production of medical devices or pharmaceuticals meet regulatory standards and function as intended. Their work involves planning and executing validation protocols, documenting results, and troubleshooting any deviations. This role is crucial for maintaining product quality, patient safety, and compliance with regulatory agencies such as the FDA. Validation Engineers often collaborate with quality assurance, manufacturing, and research teams to establish and maintain validated systems throughout a product's lifecycle.
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Validation Engineer Biomedical jobs near you

Senior Quality Engineer

Nova Biomedical

Norwood, MA • On-site

$100K - $135K/yr

Full-time

Medical, Dental, Vision, Retirement, PTO

Re-posted 5 days ago

Job description

Nova Biomedical: One Global Brand. One Vision. Together under one name.
Advanced Instruments and Nova Biomedical are now united under one brand, Nova Biomedical, marking a major milestone in our journey to deliver greater value to our customers. By combining our strengths, we're accelerating innovation, supporting critical workflows, and delivering world-class service across the biopharmaceutical and clinical markets.
Job Summary:
The Senior Quality Engineer will be responsible for providing Quality Engineering support to ensure quality practices are implemented and maintained across design transfer, inspection, production, and data monitoring. This role leads quality initiatives and projects, supports process and equipment qualification, and ensures compliance with established procedures by collaborating with R&D and Manufacturing Engineering to resolve issues. Additionally, it ensures Quality Systems are integrated into all operational activities and represents the site's quality management system by communicating and influencing leadership on continuous improvements.
Responsibilities:
  • Provide expertise and general oversight for the management and improvement of Nova Biomedical's Quality Systems, including quality planning, quality control planning, internal auditing, inspection procedures, document controls, change management, process controls, quality records, corrective and preventive activities, validations, and data management.
  • Develop plans to resolve quality issues and use communication and analytical skills to generate support for changes. Effectively communicate with leadership to weigh pros and cons of changes and present solutions that meet business and quality/compliance needs.
  • Mentor quality engineers
  • Make risk-based decisions confidently
  • Prepare and review Engineering Change Orders (ECO) and Manufacturing Variances (MV) for operating procedures and operating instructions.
  • Design and validate queries and reports for data from Production, Non-Conforming Materials and Corrective and Preventive Actions on the Database.
  • Participate in and/or lead Product Line Quality Committees (PLQC) as appropriate.
  • Format, manage and maintain Quality Control Plans and PFMEAs for new products to ensure that Quality Requirements are in place when new products are introduced into Manufacturing.
  • Review and analyze specifications relating to acceptance activities.
  • Support Quality Plan activities in support of company projects.
  • Analyze data and generate reports to identify trends and to draw effective conclusions.
  • Generate and review Validation Protocols and Reports (IQ, OQ, PQ) for adequacy, completeness, and compliance with Quality Systems requirements.
  • Participate in external audits and where appropriate interact directly with auditors to address concerns and answer queries.
  • Ensure that validation activities are appropriate to their needs and in alignment with Nova Biomedical's procedures.
  • Maintain and oversee the Nova Biomedical Validation File and Log (a Microsoft Excel file) and the Nova Biomedical Validated Spreadsheet Log (Excel) and File.
  • Identify and implement problem-solving activities to determine root cause and effective corrective action.
  • Quality Management Review: Contribute to the information gathering for the QMS management review process.
  • Assist management with improving Quality Systems and increasing plant-wide compliance with appropriate regulations.
  • Proactively identify quality system gaps and develop solutions to close gaps, leveraging existing quality systems.

Experience Requirements:
  • Bachelor's degree or higher in Engineering or the technical sciences
  • 7 plus years Medical Device/IVD Experience as a Quality Engineer, or 4+ as a Senior Quality Engineer within an FDA regulated reagents, medical device, or IVD manufacturing company.
  • Knowledge of regulations and standards affecting IVDs and Medical Devices (ISO 9001, ISO 13485, & ISO 14971, IVDR) and the ability to interpret regulations and apply appropriately
  • Experience in FDA regulated environment.
  • Excellent oral and written communication skills, prioritization, and multi-tasking skills
  • Detail-oriented, able to read and interpret technical documents
  • Works well with multi-disciplined team and understand task requirements
  • Ability to exercise judgement in selecting methods and techniques for obtaining results
  • Computer literacy including MS Word, MS Excel MS Access
  • Statistical Software experience, i.e. Minitab
  • Previous experience working with Master Control and/or Power BI a plus
  • Auditing experience and certification is preferred.

Physical Requirements and Working Conditions:
  • Ability to work in an office, laboratory, and light manufacturing environment as needed.
  • Ability to sit or stand for extended periods while reviewing documentation, participating in meetings, or supporting lab activities.
  • Ability to lift, carry, or move equipment, test fixtures, or materials up to 25 lbs occasionally.
  • Ability to perform hands-on tasks such as inspecting components, handling small parts, or supporting test setups that may require fine motor skills.
  • Ability to wear appropriate PPE (e.g., lab coat, gloves, safety glasses) when working in laboratory or production areas.
  • Ability to move between different work areas, including R&D labs, production floors, and meeting spaces.
  • Visual acuity sufficient to read engineering drawings, specifications, and test data, both on screens and on paper.
  • Occasional travel (up to 10%) to suppliers, manufacturing partners, or other company sites may be required.

Why Work for Nova Biomedical
  • Flexible Medical, Dental, & Vision Coverage
  • Competitive 401k company match
  • Bonus Program, Generous PTO and paid holidays
  • Generous Tuition reimbursement
  • Hybrid and flexible work arrangements
  • Professional development, engagement and events
  • Company marketplace for lunch and snacks in our Norwood, MA, Billerica, MA and Westbrook, ME offices
  • Company subsidized cafeteria in our Waltham, MA office

Work Location: Hybrid work schedule on-site in Norwood, MA, 4 days/week on-site
Targeted Salary Range: $110,000 - $130,000/year.
Nova Biomedical believes in transparency and integrity throughout all we do, including compensation. The provided salary range for this role represents the expected base salary or hourly rate for this opening. Actual compensation will be commensurate with the candidate's experience and may vary based on individual factors such as location, skills, and education.
About the Company
At Nova Biomedical, we're not just building instruments, we're powering breakthroughs that improve lives. Our smart, science-driven solutions are trusted in over 100 countries to speed drug development and enhance patient care.
Our integration brings together more than 70 years of scientific excellence with Nova's cutting-edge innovation, forming a powerhouse of precision, purpose, and possibility. With FDA-registered, ISO-certified manufacturing, more than 125 FDA approvals, and industry-trusted diagnostics, we're setting new standards in quality and reliability. Nova Biomedical is proud to be a global leader in osmolality testing and biotechnology and in vitro diagnostic (IVD) instrumentation, dedicated to advancing patient care and scientific discovery with a legacy that continues to shape the future of life sciences.
With headquarters in Norwood and Waltham, Massachusetts, and a global team of nearly 2,000 employees, we're building a collaborative, empowered culture grounded in shared values: Customer Centricity, Ingenuity, Ownership & Accountability, Collaboration, and Integrity.
Working at Nova Biomedical means joining a mission-driven organization where your contributions matter. Whether you're in engineering, science, manufacturing, or support, you'll be part of a team that values innovation, invests in your growth, and is committed to making a real-world impact on global health.
Explore what's next with us at novabiomedical.com
EEO Statement:
Nova Biomedical takes pride in being an equal opportunity employer committed to hiring a diverse and inclusive workforce. As a part of our commitment to a diverse and inclusive workforce, Nova Biomedical will continue to take steps to assure that recruitment, hiring, assignment, promotion, compensation, and all other personnel decisions are made and administered without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, gender expression, veteran status, age, mental or physical disability, genetic information or any other protected class.
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