Fda Entry Level Jobs in Boston, MA (NOW HIRING)

Job Summary 

Under the direction of the Sr. Manager of Research & Development, the R&D Engineer will support Design Verification and Validation (DV&V) laboratory activities, Maintenance of Business (MOB) projects, and selected New Product Development (NPD) initiatives. This entry-level position is responsible for planning, developing, executing, and documenting engineering tests in support of medical device product development and sustaining engineering efforts. 

The individual will support all phases of the product lifecycle, with a primary focus on laboratory-based design verification and validation activities, Design History File (DHF) documentation, and engineering change implementation. This role will work closely with cross-functional teams including Manufacturing, Quality, Regulatory Affairs, Marketing, Packaging, Supply Chain, and external partners to ensure products meet design, performance, and regulatory requirements. 

Responsibilities 

• Develop, execute, and document design verification and validation testing activities. 
• Assist in the design, setup, operation, and maintenance of laboratory test equipment and fixtures. 
• Create test methods, test methods validations, protocols, reports, and data summaries in accordance with applicable procedures and standards. 
• Perform hands-on testing of products, components, and assemblies to evaluate performance, reliability, and compliance with design requirements. 
• Collect, analyze, and communicate test results and observations to project teams. 
• Support Maintenance of Business (MOB) and New Product Development (NPD) projects as a contributing member of cross-functional teams. 
• Participate in engineering evaluations, product improvements, and sustaining engineering activities. 
• Develop engineering documentation including specifications, protocols, reports, risk assessments, and technical summaries. 
• Create and maintain Bills of Material (BOMs), component specifications, and finished good specifications. 
• Support engineering change implementation through the Quality Management System (QMS). 
• Support the development and maintenance of Design History File (DHF) documentation. 
• Ensure compliance with FDA Quality System Regulations (QSR), design control requirements, and internal procedures. 
• Assist in generating verification, validation, stability, and technical documentation required for product development activities. 
• Maintain accurate records of test activities and project documentation. 
• Manage assigned tasks and small projects to established timelines. 
• Provide regular status updates and communicate project risks or issues. 
• Collaborate effectively with internal and external stakeholders to achieve project objectives. 

Qualifications 

• Bachelor of Science degree in Mechanical Engineering, Biomedical Engineering, Manufacturing Engineering, or a related engineering discipline preferred. 
• Co-op, internship, laboratory, or project experience in product development, testing, manufacturing, or medical devices preferred. 
• Basic understanding of engineering principles and product development processes. 
• Hands-on aptitude with laboratory equipment, testing, fixtures, and data collection preferred. 
• Familiarity with Design Verification and Validation methodologies. 
• Basic knowledge of medical device design controls and regulated product development environments. 
• Ability to write technical documents, protocols, reports, and engineering summaries. 
• Experience analyzing data and developing solutions to well-defined technical problems preferred. 
• Ability to work effectively in cross-functional team environments. 
• Exposure to Design for Six Sigma (DFSS), Design for Manufacturing and Assembly (DFMA), or statistical methods is a plus. 
• Strong attention to detail, organizational skills, and commitment to delivering high-quality results. 

Anticipated salary range: $73,200 - $94,230

Bonus eligible: No

Benefits: Cardinal Health offers a wide variety of benefits and programs to support health and well-being.

• Medical, dental and vision coverage
• Paid time off plan
• Health savings account (HSA)
• 401k savings plan
• Access to wages before pay day with myFlexPay
• Flexible spending accounts (FSAs)
• Short- and long-term disability coverage
• Work-Life resources
• Paid parental leave
• Healthy lifestyle programs

Application window anticipated to close: 8/16/26 *if interested in opportunity, please submit application as soon as possible.

The salary range listed is an estimate. Pay at Cardinal Health is determined by multiple factors including, but not limited to, a candidate’s geographical location, relevant education, experience and skills and an evaluation of internal pay equity.

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Candidates who are back-to-work, people with disabilities, without a college degree, and Veterans are encouraged to apply.

Cardinal Health supports an inclusive workplace that values diversity of thought, experience and background. We celebrate the power of our differences to create better solutions for our customers by ensuring employees can be their authentic selves each day. Cardinal Health is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, ancestry, age, physical or mental disability, sex, sexual orientation, gender identity/expression, pregnancy, veteran status, marital status, creed, status with regard to public assistance, genetic status or any other status protected by federal, state or local law.