Sr. R&D Engineer

Innovative Health LLC•Scottsdale, AZ

About The Position

The Senior R&D Engineer designs, develops, and implements processes and projects to bring new products into production. The role supports development of medical device platforms under design controls and applicable FDA and ISO requirements, and contributes to testing, manufacturing support, process improvement, and R&D project delivery. The position coordinates project activities, test sample builds, equipment procurement, schedules, objectives, logistics, and budgets. It also supports innovation and product performance and profitability goals, while sharing technical information and best practices across R&D.

Requirements

Associate's degree in a technical field such as science, math, engineering, or a related field with three years of related experience, or a minimum of six years of related experience.
Ability to work in a fast-paced, collaborative team environment.
Ability to understand CAD drawings.
Knowledge of Geometric Dimensioning and Tolerancing (GD&T).
Strong hands-on prototyping skills.
Ability to coordinate test sample builds.
Ability to write technical documents, including procedures, test methods, protocols, and reports.
Ability to execute protocols and conduct data analysis.
Ability to train manufacturing, QC, and technician personnel.
Ability to work with little supervision.
Ability to use personal computers and software such as Word, PowerPoint, Excel, and Minitab.
Self-starter and highly motivated.
Ability to motivate and encourage other team members.

Responsibilities

Assist in developing new medical device platforms in compliance with design control processes and applicable FDA and ISO requirements.
Develop, write, and execute test methods.
Train manufacturing and QC personnel as needed on test methods or manufacturing processes.
Generate formal test protocols and reports.
Execute test protocols, conduct bench testing, and document results in accordance with GDP, ISO, and FDA requirements.
Coordinate and oversee test sample builds, and assist with builds as required.
Design and fabricate test fixtures, tooling, and equipment, if applicable.
Work with the purchasing department to specify and procure capital equipment.
Participate as a cross-functional team member in project-related activities.
Assist with or lead process improvement projects to reduce costs.
Comply with company policies and procedures.
Maintain project schedules and deliver projects on time.
Deliver products to support the R&D project pipeline.
Ensure program objectives are determined and met, logistics are coordinated, and budgets are adhered to.
Search for best-in-class competitor technologies and develop an innovation roadmap.
Support R&D projects at the group level by participating in meetings and sharing technical information and best practices.
Maximize product profitability and improve product performance.