Development Engineer

How you will contribute to the Success of Pinnacle Transplant Technologies

People who thrive on working for a growing company and want to make their mark on an organization will want to read about this opportunity. Established in 2010, 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. We offer a comprehensive portfolio of products and solutions across multiple market segments, including Spine, Sports Medicine, General Orthopedics, Trauma, Dental, and Regenerative Medicine. For over a decade, Pinnacle has helped surgeons improve the lives of thousands of patients. Pinnacle is registered with the Food and Drug Administration (FDA) and accredited by the American Association of Tissue Banks (AATB).

With guidance from the Director of R&D, this role designs, develops, modifies, evaluates, and verifies requirements for tissue-based products and regenerative medicine products, complying with PTT’s values and with federal and local government requirements. The role drives the full development process from research to product launch and it is responsible for owning assigned projects, preparing project budgets, holding project meetings, maintaining current project timelines, and actively participating in the pre-validation and validation activities

The Development Engineer position in fulltime, in person in North Phoenix. The salary offerings start at $82,500 + dependent upon experience.

Who you will Collaborate with

• Daily written and verbal communication with the Director of Research & Development and members of the Research & Development team to ensure duties and projects are understood and executed accordingly, providing routine updates on tasks and projects to Leadership and other key project members.
• Regular communication with members of cross-functional development teams through email, phone calls, and shared project timelines/dash boards to ensure all team members are aware of tasks and timelines.
• Regular communication with Operations, Regulatory, Quality, and Marketing associates to ensure products and related development activities are compliant with PTT policies and Federal regulations, and to ensure customer’s requirements and documentation are met within committed timelines

What Qualifications you will Bring

• Bachelor’s Degree in Engineering/Science (Biomedical, Chemical, or Mechanical Engineering preferred)
• 3+ years of applicable product Development Engineering experience in the medical device, tissue banking, pharmaceutical, or other highly regulated industry
• 3+ years of experience working within design controls systems and leading improvements to associated procedures and templates
• 3+ years of project management experience with complex multi-departmental initiatives
• Direct experience leading the design, development, scale, and transfer of product manufacturing processes from R&D to production environments

What you will do

• Responsible for all documentation and approvals needed to develop new products, line extensions, and private labels
• Serve as a project manager for all assigned new products projects including planning, scheduling, and coordinating project tasks and activities
• Lead pre-clinical and clinical product evaluations including feasibility studies, VOC, design validations, and post-market investigations
• Work collaboratively to document product requirements and specifications for new products
• Lead the generation of protocols and reports to collect and analyze data to evaluate performance of new designs and process improvements
• Be a strong team player with demonstrated ability to use critical thinking skills to design and develop new products
• Serve as the R&D technical expert related to customer needs, design inputs, product intended use, clinical procedures, and commercialization activities
• Lead the creation, refinement, and remediation of engineering documentation, such as the Design History File, as necessary
• Create, implement, and manage product development infrastructure, procedures, and processes such as design controls and risk management programs
• Responsible for product design and development, test method creation and validation, component and device specification generation, process analysis and documentation, pre-clinical research, and design control documentation

Additional Desired Qualifications

• Extensive knowledge of statistical techniques and software including Minitab
• Ability to solve problems and design experiments using DOE concepts
• Knowledge of risk analysis standards and techniques including ISO 14971, design and process FMEA, and other risk documentation
• Ability to lead URS requirement discussions related to equipment onboarding and maintenance processes

Company benefits package includes:

• Comprehensive medical, dental, and vision insurance, eligible first day of the month following your start date
• Company-Paid Short and Long-term Disability Insurance
• Company-Paid Identity Theft Protection
• Company-Paid Life Insurance Policy of $50,000
• 401(k) Profit Sharing Plan with a 4% company match, eligible first day of the month following 90 days of employment.
• Additional benefits such as: Additional Life/AD&D, Accident, Critical Illness, and Pet Insurance

Paid Time Off:

• Paid time off is prorated based on quarter hired:

• Quarter 1: 160 hours
• Quarter 2: 120 hours
• Quarter 2: 80 hours
• Quarter 4: 40 hours
• (1) week paid sick time, accrued per pay period beginning after 90-days of employment
• (10) annual paid holidays