Principal R&D Engineer

Cardinal Health; Robinsonville (MA); On-site; USD 108,000 - 154,000; Full time

Benefits offered by this job

Medical, dental, and vision coverage

Paid time off

Health Savings Account (HSA)

401k savings plan

myFlexPay for early wage access

Job summary

Cardinal Health is seeking a Principal Research & Development Engineer to lead the design, development, verification, validation, and lifecycle management of medical device products. The role provides strategic technical leadership across all phases of product development, ensuring compliance with design controls, regulatory standards, and quality systems.

In a highly cross-functional environment, you will guide projects, mentor engineers, and drive continuous improvement while collaborating

Qualifications

• Bachelors degree in Biomedical Engineering, Mechanical Engineering, or related field.
• 4+ years of relevant medical device experience.
• Knowledge of medical device design controls and stage-gate development process.
• Experience with CAD, preferably SolidWorks.
• Manufacturing and patent experience is a plus.
• Experience with Microsoft Project.
• DFSS certification preferred.
• Proven PM experience in product development.

Responsibilities

• Lead new product development, enhancements, and sustaining engineering programs for medical devices.
• Develop design strategies and ensure compliance with FDA, ISO, IEC, EN standards.
• Support 510(k) submissions and regulatory requirements.
• Create and review technical specifications, protocols, and reports for verifications and validations.
• Perform design reviews and manage change through the development lifecycle.
• Coordinate product transfers from R&D to manufacturing.
• Travel as needed to support projects.

Skills

Project management

Design controls knowledge

Risk management

Cross-functional collaboration

Regulatory knowledge

Education

Bachelors or higher in Biomedical/Mechanical Engineering or related field

Tools

SolidWorks

Microsoft Project

Job description

Job SummaryThe 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.QualificationsBachelor’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.Anticipated salary range: $107,900 - $154,100Bonus eligible: NoBenefits: Cardinal Health offers a wide variety of benefits and programs to support health and well-being.Medical, dental and vision coveragePaid time off planHealth savings account (HSA)401k savings planAccess to wages before pay day with myFlexPayFlexible spending accounts (FSAs)Short- and long-term disability coverageWork-Life resourcesPaid parental leaveHealthy lifestyle programsApplication window anticipated to close: 10/12/26If 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.#LI-JB1Cardinal 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 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.To read and review this privacy notice click here