Sr. R&D Engineer

Cardinal Health•Mansfield, MA

1d•$90,200 - $115,830•Hybrid

About The Position

The Sr Research and Development Engineer will perform new product design and development activities as well as legacy product sustaining engineering activities. These activities will cover all phases of the product life cycle from concept through end of life. Attention to detail and working knowledge of regulations for the medical device industry are essential.

Requirements

Bachelor’s degree in biomedical, Mechanical, or other related engineering degree preferred
2+ years of experience in new product development 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 mechanical systems and component level design.
Experience with CAD preferably SolidWorks.
Ability to work independently and as a member of a team
Developed leadership, problem solving, decision making, and presentation skills
Excellent personal and team leadership skills may act as mentor to less experienced colleagues

Nice To Haves

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

Responsibilities

Leads small-scale R&D projects from conception to completion and serves as a critical core team member on large-scale new product development initiatives.
Contributes to projects for the sustaining of Medical Devices.
Work on complex projects of large scope and provide technical leadership for Medical Device 510k submissions for new products.
Effectively and thoughtfully incorporate required regulatory medical device standards (FDA, ISO, IEC, EN).
Conduct product development tasks & documentation required to satisfy design controls and risk management following established SOPs.
Develops and maintains robust product technical specifications, designs and validates test methods for finished devices or components and establishes verification and validation protocols to ensure product safety, efficacy, and compliance.
Conducts in-depth research and analysis of existing products and technologies to identify opportunities for innovative solutions.
Collaborates effectively with diverse cross-functional teams in various locations of USA, Asia and Latin America including Marketing, Design Quality Engineering (DQE), Regulatory Affairs (RA), Manufacturing, and other technical groups such as 3rd party design engineering resources to ensure seamless product development and launch.
Provides clear, concise, and regular updates on project status, risks and issues, timelines, and budgetary expenditures to stakeholders, ensuring transparency and proactive issue resolution.
Drives the successful execution of R&D-led projects by applying focused effort, fostering transparent communication, and implementing streamlined processes to meet existing and new commitments.
Supports product transfer from R&D to manufacturing.
Proactively identifies, analyzes, and implements effective technical solutions to complex engineering challenges, driving continuous improvement in product design and processes.
Operates with a degree of independent judgment within established parameters, seeking general guidance on routine tasks and more detailed instruction on novel or highly complex projects, fostering continuous professional development.