Design Engineer

Job Description

Job Description

About Us

Pinnacle Transplant Technologies is a multi-service tissue bank committed to honoring the gift of donation and improving patient’s quality of life through the processing and distribution of high-quality allograft implants.

For over a decade, Pinnacle has helped surgeons improve the lives of thousands of patients. We offer a comprehensive portfolio of products and solutions across multiple market segments, including Spine, Sports Medicine, General Orthopedics, Trauma, Dental, and Regenerative Medicine.

Pinnacle is registered with the Food and Drug Administration (FDA) and accredited by the American Association of Tissue Banks (AATB).

How You Contribute to Pinnacle Transplant’s Success

The Design Engineer may be responsible for all or multiple stages of a project relating to creating, maintaining, and improving production processes and / or products in the manufacturing cleanroom environment.

He / she is expected to contribute individually or on a team to the success of projects by brainstorming solutions, refining ideas, and using existing or devising new processes to evaluate or improve product or process performance.

The Design Engineer will possess technical expertise and experience with design, manufacturing, and process control with proficiency in project management.

The Design Engineer is an onsite position located in North Phoenix (19th Ave & 101)

Salary is dependent upon experience / education ranging from $60,000 - $90,000

What You Will Do

• Design and manufacture prototypes and fixtures using CNC equipment
• Provide organizational subject matter expertise using Solidworks
• Establish and lead rapid prototyping capabilities within R&D
• Collaborate with NPD to design, develop, and implement new products and capital projects
• Collaborate with New Product Development, Operations, and outside vendors regarding product tooling, equipment, and gauge design as well as product design to ensure effective production methods
• Develop process parameters, inputs, and testing required to validate a new or improved manufacturing process, design, or graft
• Improve efficiencies by analyzing and planning workflow, space requirements, and equipment layout and making recommendations to R&D and Operations leadership
• Work closely with R&D and Operations leadership to develop, coordinate, and implement technical training for associates
• Partner with vendors in determining product and / or process specifications and arranging equipment, parts, or material purchase, and evaluating according to quality standards and specifications.
• Complete projects within allotted timelines and budget
• Work to create and / or refine appropriate preventative maintenance procedures and schedules
• Work to create and / or refine appropriate calibration procedures and schedules
• Provide support to Operations department to troubleshoot and resolve technical problems
• Support company policies and procedures, goals and objectives, FDA and AATB regulations, local, state, and federal laws, and good manufacturing practices

What Qualifications You Will Bring

• Bachelor’s Degree in Engineering / Science (Biomedical, Chemical, or Mechanical Engineering preferred)
• Minimum of 3 years of design, product development, process, or manufacturing engineering experience within a pharmaceutical, medical device, biologic, tissue bank, diagnostic, hospital, or similar organization
• Minimum of 3 years of experience leading the design, programming, and manufacturing of CNC machined parts
• Knowledge and experience with CNC and Solidworks CAD programming, 3D printing, and rapid prototyping is required
• Experience in applying statistical methods and lean manufacturing principles for product, process, and quality improvements.

How You Will Grow

• Develop skills in Design Engineering, programming, manufacturing engineering
• Continuous improvements of processes and documentation
• Continued growth within design control and process validation, process capability, control, and monitoring analysis, root cause analysis, corrective and preventive action (CAPA), sterilization validation, and packaging validation

Who You Will Partner With

• Daily written and verbal communication with R&D, Quality, Regulatory, and Operations to ensure all duties are understood and executed in a timely manner while in compliance with applicable regulations.
• Regular communication with R&D, Quality, Regulatory, and Operations to ensure all processes and products are in compliance with PTT policies and applicable regulations.

Where You Will Work

You will work in a clean room / lab environment in a manufacturing facility in North Phoenix, having contact with human tissue and bone.

You are required to wear protective clothing including but not limited to hoods, face masks, gloves, boots, and coveralls.

Your work is physical in nature. It will require standing for long periods of time, exerting up to 20 pounds of force occasionally and 40 pounds of force frequently to move objects.

It also requires repetitive motion with substantial movements of the wrists, hands, and / or fingers.

You may be required to use equipment including but not limited to band saw, surgical instrumentation, autoclave, lyophilizer, moisture analyzer, heat sealer, sonicator, microscope, centrifuge, controlled rate freezer, cryo mill, calipers, desktop computers, and general office equipment.

You will work in an office environment in a manufacturing facility in North Phoenix, having periodic contact with human tissue and bone.

You may be required to be in a cleanroom environment, where you will wear protective clothing including but not limited to hoods, face masks, gloves, boots, and coveralls.