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Validation Engineer Biomedical Jobs in Massachusetts

Nova Biomedical

Software Engineer Manager

Norwood, MA ยท On-site

Nova Biomedical: One Global Brand. One Vision. Together under one name. Advanced Instruments and ... verification, validation, commercial release, and post-market support. * Ensure software ...

Nova Biomedical

Software Engineer Manager

Norwood, MA ยท On-site

Nova Biomedical: One Global Brand. One Vision. Together under one name. Advanced Instruments and ... verification, validation, commercial release, and post-market support. * Ensure software ...

Nova Biomedical

Senior Software QA Engineer

Norwood, MA ยท On-site

Nova Biomedical: One Global Brand. One Vision. Together under one name. Advanced Instruments and ... Contribute to software verification and validation activities supporting new product development ...

Agiliti

Biomedical Equipment Technician

Boston, MA ยท On-site

$28.38 - $45.41/hr

An associate degree in electronics, mechanical engineering, or biomedical equipment technology ... Must hold a current, valid, and unrestricted driver's license. Must have a safe driving record ...

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Validation Engineer Biomedical information

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.

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 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 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 popular job titles related to Validation Engineer Biomedical jobs in Massachusetts?

For Validation Engineer Biomedical jobs in Massachusetts, the most frequently searched job titles are:

What job categories do people searching Validation Engineer Biomedical jobs in Massachusetts look for?

The top searched job categories for Validation Engineer Biomedical jobs in Massachusetts are:

What cities in Massachusetts are hiring for Validation Engineer Biomedical jobs?

Cities in Massachusetts with the most Validation Engineer Biomedical job openings:

Validation Engineer Biomedical jobs near you
Infographic showing various Validation Engineer Biomedical job openings in Massachusetts as of August 2026, with employment types broken down into 100% Contract. Highlights an 100% In-person job distribution.

Senior Plastics Process Engineer

Nova Biomedical Corporation

Billerica, MA โ€ข On-site

$130K - $145K/yr

Full-time

Medical, Dental, Vision, Retirement, PTO

Posted 15 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 Sr. Plastics Processing Engineer for the injection molding department has responsibility for developing injection molding process parameters for new and existing molds. As the Sr. Plastics Processing Engineer, you will have guidance and oversight on daily operations within the mold shop including supporting production schedules, maintaining equipment within the department, establishing molding process parameters, executing mold process validations, and resolving molding issues.
Responsibilities :
  • Establish and optimize injection molding process parameters on new and existing molds using scientific molding principles.
  • Provide technical guidance and support to mold technicians and operators within the department.
  • Establish short term projects and be a mentor for department Plastics Engineering coops.
  • Help foster a culture of accountability, teamwork, safety, and continuous improvement.
  • Oversee maintenance, repair, and revision change to molds within the Nova Mold Shop.
  • Execute mold validations and equipment qualifications.
  • Review externally sourced plastic part designs for internal molding opportunities. Provide technical support to R&D as needed for mold development.
  • As required, develop and revise departmental procedures related to molding operations, quality control, safety, and best practices for the Mold Shop. Create and execute Engineering Change Orders (ECO).
  • Lead the evaluation and selection of injection molding machines and ancillary equipment for the Mold Shop when required.
  • Technical point of contact for external resin and molding equipment suppliers.
  • Execute continuous improvement projects focusing on quality, cost reductions, and efficiency.
  • Other duties as assigned.

Experience Requirements:
  • Confidence and hands-on experience establishing injection molding parameters using Scientific Molding principles (Decoupled molding) is required.
  • Master Molder I certification preferred. Master Molder II certification a plus.
  • Ability to work independently at times solving mold and process issues and conducting mold validations.
  • Ability to clearly articulate and train others on injection molding process development and equipment functionality.
  • BS in Plastics Engineering or equivalent curriculum is required. MS is a plus

Physical Requirements and Working Conditions:
  • Able to stand, walk, and move for extended periods.
  • Capacity to lift and carry up to [25๏ฟฝ50] pounds as required.
  • Comfort with performing repetitive physical tasks.
  • Able to bend, reach, stoop, or climb as needed.
  • Willingness to work in varying environmental conditions (e.g., noise, temperature, equipment).
  • Proficiency in operating tools, machinery, or technical equipment.
  • Use of appropriate personal protective equipment (PPE) 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: On-site in our Billerica, MA Lexington rd. facility
Targeted Salary Range: $130,000 - $145,000/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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