Sr. R&D Engineer

Innovative Health•Scottsdale, AZ

About The Position

The Senior R&D Engineer designs, develops, and implements processes and projects to transition new products into production. The role supports development of medical device platforms in accordance with design controls and applicable FDA and ISO requirements, and delivers products in support of the R&D project pipeline. It also contributes to product innovation, profitability, and performance while coordinating project objectives, logistics, schedules, and budgets. The position has no supervisory responsibilities. The work takes place in office and manufacturing settings. It involves routine use of standard office equipment and frequent exposure to odors, fumes, dust or airborne particles, moving mechanical parts, vibration, and potentially loud noise. The role regularly requires talking or hearing; frequently requires standing, walking, handling objects, and reaching; and occasionally requires sitting, climbing or balancing, stooping, kneeling, crouching, or crawling. Occasional lifting or moving of up to 20 pounds is required. Specific vision abilities include close, distance, color, and peripheral vision, depth perception, and adjusting focus.

Requirements

Associate's degree in a technical field such as science, math, or engineering, with three years of related experience; alternatively, 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 while complying 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.
Serve as a cross-functional team member for 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.
Support the R&D project pipeline by delivering products.
Ensure program objectives are determined and met, logistics are coordinated, and budgets are adhered to.
Identify best-in-class technologies among competitors and develop an innovation roadmap.
Support group-level R&D projects by participating in meetings and sharing technical information and best practices.
Maximize product profitability and improve product performance.