Sr. R&D Engineer

Sr. R&D Engineer

Job Summary

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.

Schedule:

Hybrid - 3x week in office

Responsibilities

* Project Leadership & Contribution: 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.

* Senior Technical Lead:
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.

* Design & Verification: 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.

* Product Feasibility &

Innovation: Conducts in-depth research and analysis of existing products and technologies to identify opportunities for innovative solutions.

* Cross-Functional Collaboration:

 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.

* Project Management & Communication: Provides clear, concise, and regular updates on project status, risks and issues, timelines, and budgetary expenditures to stakeholders, ensuring transparency and proactive issue resolution.

* Strategic Execution: 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.

* Problem Solving & Continuous Improvement: Proactively identifies, analyzes, and implements effective technical solutions to complex engineering challenges, driving continuous improvement in product design and processes.

* Autonomy & Growth: 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.

Qualifications

* Bachelor's degree in biomedical, Mechanical, or other related engineering degree preferred

* Preferred

Certifications:

DFSS, DFMA

* 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 Solid Works.

* Manufacturing and Patent Experience is a plus.

* Non-Woven product experience is a plus (Surgical Drapes, Gowns, Facial Protection, etc.)

* 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

* Travel Expectations: 10%

Anticipated salary range: $90,200 - $115,830

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 myFlex Pay

* Flexible spending accounts (FSAs)

* Short- and long-term disability coverage

* Work-Life…