Principal R&D Engineer - PPE

Cardinal Health•Mansfield, MA

1d•Onsite

About The Position

Principal 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 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. Schedule: 3x week in office

Requirements

Bachelor's degree in Biomedical, Mechanical, or other related engineering degree preferred
4+ years of experience in medical device industry preferred
Knowledge of Medical Device design controls, Stage Gate product development process.
Proven track record of successful technical project management in a product development environment
Knowledge of Plastics Injection Molding Designs.
Knowledge of mechanical systems and component level design.
Experience with CAD preferably SolidWorks.
Ability to work independently and lead a team
Self-Driven/Motivated/Proactive & Strong Background in Multitasking
Excellent personal and team leadership skills may act as mentor to less experienced colleagues.

Nice To Haves

Preferred Certifications: DFSS
Manufacturing and Patent Experience is a plus.
Non-Woven product experience is a plus (Surgical Drapes, Gowns, Facial Protection, etc.)

Responsibilities

Contribute to the development and maintenance of Medical Devices.
Effectively and thoughtfully incorporate required regulatory medical device standards (FDA, ISO, IEC, EN).
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 following SOP’s.
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 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.
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.

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