R&D Sr. Engineer

Research and Development Engineering is responsible for developing and implementing new products through adherence to established design control processes and good engineering and documentation practices. A Senior Research and Development Engineer will perform design and development as well as product sustaining engineering activities. These activities will cover all phases of the product life cycle from concept through end of life. The individual in this position will often lead small to large scale projects but will also assume an individual contributor role. The engineer must have the flexibility of skills and temperament to work in both product development and product change development. Attention to detail and working knowledge of regulations for the medical device industry are essential. The engineer must be able to work in a team environment and be able to communicate clearly across all disciplines including Quality Assurance, Regulatory Affairs, Manufacturing, Marketing, outside design partners, and regulatory agencies. This role is onsite in our Mansfield, MA facility. The position is hybrid (3+ days onsite).

Responsibilities:

• Contribute to the development and maintenance of Medical Devices.
• 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.
• Construct Design History Files in accordance with SOPs.
• Write protocols and reports for various technical aspects including design verifications and validations, as well as provide solutions and implementations using established Change Development Process.
• Conduct and/or orchestrate device and component testing.
• Conduct product development tasks & documentation required to satisfy design controls and risk management in accordance with established SOPs.
• Provide presentations, reports and schedules as required to manage projects and to communicate status, risks and issues.
• The ability to work with a diverse team in various locations in the US, Asia and other locations will be required.
• Excellent personal and team leadership skills may act as mentor to less experienced colleagues.
• Product transfer from R&D to manufacturing.
• Travel to support and drive projects, no more than 5%.

Qualifications:

• Bachelor’s Degree or higher in Biomedical Engineering, Mechanical Engineering, or related field, preferred or equivalent work experience.
• 2 – 5 years of relevant medical device experience, preferred.
• A minimum of 2+ years related work experience preferred.
• Ability to work independently and as a member of a team.
• Knowledge of Medical Device design controls and Stage Gate product development process, preferred.
• Applies comprehensive knowledge and a thorough understanding of concepts, principles, and technical capabilities to perform varied tasks and projects.
• Self-Driven/Motivated/Proactive & Strong Background in Multitasking.
• Strong written, verbal, and presentation skills.
• Ability to thrive in a dynamic environment.
• Proven track record of successful technical project management in a product development environment.
• Knowledge of Plastics Injection Molding Designs, preferred.
• Knowledge of mechanical systems and component level design.
• Experience with CAD preferably SolidWorks.
• MS office tools including Word, Excel, PowerPoint, Project.
• Design for Six Sigma (DFSS) trained and certified is a plus.
• Manufacturing and Patent Experience is a plus.
• Non-Woven, the Converting of Non-woven is a plus.
• Urology, Folly Catheters, Drain Bags is a plus.

What is expected of you and others at this level:

• Applies working knowledge in the application of concepts, principles, and technical capabilities to perform varied tasks.
• Works on projects of moderate scope and complexity.
• Identifies possible solutions to a variety of technical problems and takes actions to resolve.
• Applies judgment within defined parameters.
• Receives general guidance may receive more detailed instruction on new projects.
• Work reviewed for sound reasoning and accuracy.

Anticipated salary range: $79,300 - $113,200

Benefits:

• 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.

Application window anticipated to close: 7/18/2025. 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.

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.