R&D Sr. Engineer

What R & D Engineering contributes to Cardinal Health

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 

Successful candidate for this role needs to be adaptable with the ability to navigate in a dynamic environment where requirements and business situations evolve rapidly. To be successful in this role, the candidate typically exhibits the following attributes.

• 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 SOP’s.

• 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 location will be required. This will include Quality, Regulatory, Manufacturing, and other technical groups such as 3rd party design engineering resources.

• 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

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