Principal R&D Engineer

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

Benefits offered by this job

Medical, dental and vision coverage

Paid time off

401k savings plan

HSA and FSAs

Job summary

Cardinal Health is seeking a Principal R&D Engineer to lead design, development, verification and lifecycle management of medical device products. You will drive cross-functional projects, ensure regulatory compliance (FDA, ISO, IEC, EN) and mentor engineering teams across locations in the US and abroad.

The role includes design transfers to manufacturing and 510(k) submissions. Ideal candidates have a Biomedical or Mechanical Engineering background, DFSS certification, 4+ years of medical

Qualifications

• Bachelor's degree in Biomedical or Mechanical Engineering or related field.
• DFSS certification is preferred.
• 4+ years of medical device experience is preferred.
• Proven track record of technical project management in product development.
• Knowledge of medical device design controls and stage-gate processes.
• Knowledge of mechanical systems, plastics injection molding and component designs.
• Experience with CAD, preferably SolidWorks.
• Manufacturing and patent experience is a plus.
• Experience with Microsoft Project preferred.

Responsibilities

• Lead new product development, enhancements and sustaining engineering for medical devices.
• Develop and execute design strategies satisfying regulatory standards (FDA, ISO, IEC, EN).
• Provide technical leadership for 510(k) submissions and product transfers to manufacturing.
• Produce design plans, specifications, reviews, tests and reports.
• Conduct verification, validation and risk management per SOPs and design controls.
• Collaborate across QA, Regulatory, Manufacturing, Clinical, HR and external partners.
• Mentor engineering teams and drive continuous improvement initiatives.

Skills

Project management

Risk management

Cross-functional collaboration

Problem solving

Education

Bachelor's degree in Biomedical or Mechanical Engineering

Design for Six Sigma (DFSS) certification

Tools

SolidWorks

Microsoft Project

Job description

**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.**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