Sr. R&D Engineer

Innovative Health LLC; Scottsdale (AZ); On-site; USD 110,000 - 140,000; Full time

Job summary

Innovative Health LLC is seeking a Senior R&D Engineer to design, develop, and implement processes for new products into production. You will lead cross-functional projects, create and test protocols, and coordinate sample builds in a fast-paced medical device environment.

The role emphasizes hands-on prototyping, GD&T-knowledge, and strong documentation skills to ensure design controls are met and products meet performance targets.

Qualifications

• Associate's degree in technical field with three years related experience or a minimum of six years related experience.

Responsibilities

• Assist in development of new medical device platforms per design controls and FDA/ISO requirements.
• Develop, write, and execute test methods.
• Train manufacturing/QC personnel on test methods or processes.
• Generate formal test protocols and reports.
• Execute test protocols and bench test; document results per GDP, ISO, FDA.
• Coordinate and oversee test sample builds.
• Design and fabricate test fixtures, tooling and equipment.
• Work with purchasing to specify and procure capital equipment.
• Cross-functional team member for project activities.
• Assist or lead process improvement projects to reduce costs.
• Maintain project schedules and deliver on time.
• Focus on delivering products to support R&D pipeline.
• Ensure objectives, logistics, and budgets are met.
• Search for best-in-class technologies and develop an innovation roadmap.
• Support R&D projects at group level sharing best practices.
• Maximize product profitability and improve performance.

Skills

CAD drawings

GD&T

Prototyping

Test sample builds

Technical documents

Data analysis

Training technicians

Education

Associate's degree in technical field

Minimum 6 years related experience

Tools

Minitab

Excel

Job description

Position Summary:

The Senior R&D Engineer role is responsible for designing, developing and implementing various processes and projects for new products into production.

Essential Duties and Responsibilities:

• Assists in development of new medical device platforms complying with design control process including applicable FDA and ISO requirements.
• Develops, writes and executes test methods.
• Train manufacturing/QC personnel as needed on test methods or manufacturing processes.
• Generate formal test protocols and reports.
• Execute test protocols and conduct bench testing. Document test results per GDP, ISO and FDA requirements.
• Coordinate and oversee test sample builds. Assist with test sample builds as required.
• Design and fabricate test fixtures, tooling and equipment. (if applicable)
• Work with purchasing department to specify and procure capital equipment.
• Serves as a cross function team member for various project related activities.
• Assist or lead process improvement projects to reduce costs.
• Complies with company policies and procedures.
• Maintains project schedule and delivers projects on time.
• Focuses on delivering products to support the R&D project pipeline.
• Ensure that program objectives are determined and met, logistics are effectively coordinated and budgets are adhered to.
• Actively searches for best-in-class technologies among competitors and develops innovation roadmap.
• Supports R&D projects at group level participating in meetings and sharing technical information and \"best-practices\".
• Maximizes product profitability and improve product performances.

Supervisory Responsibilities:

• None

Education, Qualifications and Skills:

• Associate's degree in technical field (science, math, engineering or other related degree) with three years related experience or a minimum of six years 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 (procedures, test methods, protocols and reports).
• Ability to execute protocols and conduct data analysis.
• Ability to train manufacturing/QC/technicians.
• Ability to work with little supervision.
• Ability to use personal computers including software such as: Word, PowerPoint, Excel, and Minitab.
• Self-starter and highly motivated.
• Ability to have fun by motivating and encouraging other team members.

Work Environment:

• This job operates in a clerical, office, as well as a manufacturing setting. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines.
• While performing the duties of this job, the employee is frequently exposed to odors, fumes, dust or airborne particles, moving mechanical parts and vibration. The noise level in the work environment and job sites can be loud.
• The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
• While performing the duties of this job, the employee is regularly required to talk or hear. The employee frequently is required to stand; walk; use hands to finger, handle or feel; and reach with hands and arms.
• The employee is occasionally required to sit; climb or balance; and stoop, kneel, crouch or crawl. The employee must occasionally lift and/or move up to 20 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.