Principal R&D Engineer

Cardinal Health; United States; On-site; USD 108,000 - 154,000; Full time

Benefits offered by this job

Medical, dental and vision coverage

Paid time off

401k plan

Job summary

Cardinal Health seeks an experienced Principal Research & Development Engineer to lead medical device product development, verification, validation, and lifecycle management. You will work across QA, Regulatory, Manufacturing, Clinical, Human Factors, and Marketing to ensure safe, effective solutions.

You will guide design strategies, risk management, and change processes, while mentoring teams and influencing technical direction for lifecycle success across locations in the US and abroad.

Qualifications

• Bachelor’s degree or higher in Biomedical or Mechanical Engineering or related field.
• Design for Six Sigma (DFSS) certification preferred.

Responsibilities

• Lead new product development, enhancements, and sustaining engineering for medical devices.
• Incorporate regulatory standards (FDA/ISO/IEC) into design strategies.
• Lead complex projects and contribute to 510(k) submissions for new products.
• Develop and review design verifications/validations and risk management activities.
• Mentor engineering teams and drive cross-functional collaboration across QA, Regulatory, Manufacturing, and Marketing.

Skills

Technical leadership

Product development

Regulatory knowledge

Cross-functional collaboration

Risk management

Verification & validation

Change management

Education

Bachelor’s degree in Biomedical/Mechanical Engineering or related field

Design for Six Sigma (DFSS) certification

Tools

SolidWorks

CAD software

Microsoft Project

Job description

Job Summary

Job Summary The Principal Research & Development Engineer is a technical leader responsible for the design, development, verification, validation, commercialization, and lifecycle management of medical device products. This role provides strategic and technical leadership across all phases of product development, ensuring compliance with design control requirements, regulatory standards, quality systems, and engineering best practices. The Principal R&D Engineer leads complex product development and sustaining engineering initiatives while serving as a subject matter expert in product design, risk management, verification and validation, and change management. Working in a highly cross-functional environment, the engineer collaborates with Quality Assurance, Regulatory Affairs, Manufacturing, Clinical Affairs, Human Factors, Marketing, suppliers, and external partners to deliver safe, effective, and innovative healthcare solutions. In addition to project leadership, the Principal R&D Engineer drives continuous improvement efforts, supports technical problem-solving and root cause investigations, and mentors engineering teams. The individual is expected to influence technical strategy, guide critical business decisions, and ensure products consistently meet customer needs, intended use requirements, and regulatory expectations throughout the product lifecycle.

Responsibilities

• Lead new product development, product enhancements, and sustaining engineering programs of Medical Devices.
• Develop and execute design strategies effectively and thoughtfully incorporate required regulatory medical device standards (FDA, ISO, IEC, EN).
• This position will work on complex projects of large scope and will provide technical leadership for Medical Device 510k submissions for new products.
• Contribute to the development of policies and procedures.
• Write and review technical specifications.
• Conduct technical and design reviews.
• Write protocols and reports for various technical aspects including design verifications and validations.
• Conduct and/or orchestrate Fished device and or part level testing.
• Conduct product development tasks & documentation required to satisfy design controls (Design History) and risk management following established SOPs.
• Provide presentations, reports and schedules required to manage projects and to communicate status, risks and issues.
• Provide solutions to technical issues and implement using the established Change Development Process.
• The ability to work with a diverse team in various locations in the US, Asia and other locations will be required.
• This will include Quality, Regulatory, Manufacturing, and other technical groups such as 3rd party design engineering resources.
• Product transfer from R&D to manufacturing.
• Travel to support and Drive Projects as needed.

Qualifications

• Bachelor’s Degree or higher in Biomedical Engineering, Mechanical Engineering, or related field preferred.
• Preferred Certifications: Design for Six Sigma (DFSS) 4+ years of relevant medical device experience preferred.
• Proven track record of successful technical project management in a product development environment preferred.
• Knowledge of medical device design controls, stage gate product development process preferred.
• Knowledge of mechanical systems, plastics Injection Molding and component designs preferred.
• Experience with CAD, preferably SolidWorks is a plus.
• Manufacturing and Patent Experience is a plus.
• Experience with Microsoft Project preferred.

Salary and Benefits

Anticipated salary range: $107,900 - $154,100 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: 10/12/26

Equal Opportunity and Diversity Statement

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.

Corporate Overview

Headquartered in Dublin, Ohio, Cardinal Health, Inc. (NYSE: CAH) is a distributor of pharmaceuticals, a global manufacturer and distributor of medical and laboratory products, and a provider of performance and data solutions for healthcare facilities. We are a crucial link between the clinical and operational sides of healthcare, delivering end‑to‑end solutions and data‑driving insights that advance healthcare and improve lives every day. With deep partnerships, diverse perspectives and innovative digital solutions, we build connections across the continuum of care. With more than 50 years of experience, we seize the opportunity to address healthcare's most complicated challenges — now, and in the future.

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