Quality Engineer in North Attleboro, Massachusetts at Theragenics Corp

No relocation available-no visa sponsorship

Compensation will be determined based on the candidate’s level of experience and qualifications

Be part of a mission that matters join Theragenics as a Quality Engineer (V&V) and help drive the production of life-saving medical devices used in cutting-edge healthcare treatments. In this critical role, you'll ensure the safety, efficacy, and compliance of advanced systems to support the development of precision-targeted therapies, contributing directly to the creation of medical devices that improve and extend lives. If you're passionate about quality, technical accuracy, and making a meaningful impact in healthcare, this is your opportunity to help shape the future of patient care.

Company Overview

At Theragenics, we're passionate about transforming healthcare and enhancing patient outcomes. Our commitment to innovation drives us to push the boundaries of what's possible, ensuring a brighter future for patients everywhere. Theragenics is a leader in developing medical devices that focus on minimally invasive treatments for cancer, blood vessel procedures, and surgical applications. The company is based in Atlanta, Georgia, and has facilities in Costa Rica, Texas, and Massachusetts. Theragenics proudly operates Arrotek, a visionary medical device design consultancy in the U.S. and Ireland, dedicated to pioneering minimally invasive solutions that enhance lives.

Purpose

Responsible for Design Verification (DV), Validation (V&V), and Design Controls. Incumbent will plan, execute, document and maintain verification and validation activities to ensure compliance with applicable regulatory and quality system requirements, including FDA regulations, ISO 13485, and EU MDR. The Quality Engineer will collaborate cross-functionally with Engineering, Manufacturing, and Quality teams to support both product development and contract manufacturing in a regulated medical device environment.

Essential Duties and Responsibilities

Design Verification & Validation

• Collaborate with engineering teams to ensure requirements are clear, measurable, testable, and traceable from user needs through design inputs, verification, and validation activities.
• Develop and execute comprehensive V&V strategies, including system-level test plans, verification protocols, validation plans, and regression testing strategies.
• Perform investigational, component, subassembly, system, reliability, and formal verification and validation testing.
• Prepare, review, and approve V&V documentation, including protocols, reports, trace matrices, and verification results.
• Ensure verification activities provide robust coverage of product requirements and identified risks.

Test Method Development

• Design, validate, and implement test methods and fixtures, including manual and automated test systems.
• Conduct measurement system evaluations to demonstrate test method suitability, repeatability, reproducibility, and accuracy.
• Support development and qualification of inspection and test equipment.

Quality & Compliance

• Ensure compliance with applicable regulatory and industry standards, including FDA 21 CFR Part 820, ISO 13485, ISO 14971, IEC 60601, and EU MDR requirements.
• Maintain testing infrastructure and equipment in a calibrated, qualified, and compliant state.
• Support internal, customer, and regulatory audits and inspections.
• Participate in design transfer activities and support complaint investigations as required.

Problem Solving & Continuous Improvement

• Investigate nonconformances, deviations, out-of-specification results, and test failures.
• Lead or support root cause investigations and implementation of corrective and preventive actions (CAPA).
• Partner with Design Engineering, Manufacturing, and Quality teams to drive continuous improvement initiatives.

Additional Responsibilities

• Perform other duties as assigned.

Qualifications

• Bachelor’s degree in engineering discipline, preferably Biomedical Engineering, Mechanical Engineering, Electrical Engineering or related technical discipline.
• Minimum 3 years experience in medical device industry in the capacity of quality engineering, verification & validation and/or product development positions.
• Experienced with support of Class II and/or Class III medical devices preferred.
• Experience with design controls and product development processes is required.
• Knowledge of FDA 21 CFR 820 and ISO 13485.
• Strong analytical and communication skills.

Preferred Qualifications

• Experience developing and validating test methods in accordance with industry best practices.
• Familiarity with reliability testing, measurement system analysis (MSA), and Gage R&R methodologies.
• Experience supporting FDA inspections, ISO audits, and customer audits.
• Experience within a contract design and manufacturing environment.

Knowledge, Skills & Abilities

• Strong understanding of Design Controls and medical device product development processes.
• Working knowledge of FDA 21 CFR Part 820, ISO 13485, ISO 14971, EU MDR, and related regulatory requirements.
• Experience with risk management tools and methodologies, including Hazard Analysis, FMEA, and Risk Management Planning.
• Proficiency in statistical analysis, sample size justification, and data interpretation for verification and validation activities.
• Strong analytical and problem-solving skills with exceptional attention to detail.
• Excellent technical writing, documentation, and communication skills.
• Ability to work independently while effectively collaborating within cross-functional teams.
• ASQ certifications such as CQE, CQA, or CQV are preferred.

Competencies

• Design Controls & V&V Expertise
• Regulatory Compliance
• Statistical Analysis and data interpretation
• Problem Solving & Continuous Improvement
• Cross-functional Collaboration

Physical Requirements & Work Environment

This role operates in an office, lab, and manufacturing setting. May require standing, walking, and lifting up to 25 lbs. Hands-on laboratory and manufacturing, and office environment. Ability to manipulate small components and tools requiring fine motor skills. Ability to sit or stand for extended periods during prototyping and testing activities. Occasional lifting of materials or equipment consistent with engineering lab environments.

Why Join Us

• Purpose-Driven Work: Every day, your engineering skills directly impact the reliability of devices that save and improve human lives.
• Innovative Projects: Work on the cutting edge of minimally invasive medical solutions and advanced medical technology.
• Collaborative Culture: Be part of a highly cooperative, cross-functional team that values precision, technical excellence, and open communication.
• Career Growth: Expand your expertise across diverse product lines, regulatory landscapes (FDA & EU MDR), and contract manufacturing settings.
• Competitive Benefits: Enjoy a comprehensive total rewards package designed to support your professional journey and personal well-being.

Ready to make a difference? Apply today and be part of something extraordinary.