Design Assurance Engineer 2 - Onsite

Job DescriptionJob Description

Onsite in Alachua, FL

While this is intended to be an accurate reflection of the current job, it is not necessarily an exhaustive list of all responsibilities, skills, duties, requirements, or working conditions associated with the job. RTI Surgical, Inc., reserves the right to revise the job or require that other or different tasks are performed when circumstances warrant (i.e., emergencies, changes in personnel or staffing, workload, or technical developments).

SUMMARY:

RTI Surgical (RTI) is a global industry-leading contract development and manufacturing organization (CDMO) in regenerative medicine. As the only regenerative medicine company that offers a differentiated portfolio of allograft and xenograft biomaterials at scale, RTI provides customers across a diverse set of market segments with leading-edge expertise, scale, and flexibility across end-to-end services including design, development, regulatory support, verification and validation, manufacturing, and supply chain management. RTI is headquartered in Alachua, FL, and has manufacturing facilities in West Lafayette, IN., Eden Prairie and Glencoe, MN. and Neunkirchen, Germany.

RTI is rooted in a steadfast commitment to quality, integrity, and patient safety with a focus on five key values:

• Accountable: We own our actions and decisions.
• Agile: We embrace change to stay ahead of the curve and evolve to drive innovation and growth.
• Growth Mindset: We embrace challenges as opportunities for continuous learning.
• Customer-Centric: We prioritize customers at every touch point.
• Inclusive: We thrive on the richness of our and ensure every voice is heard, respected, and celebrated.

At RTI Surgical, we are committed to fostering an inclusive workplace where we embrace the richness of our and ensure that every voice is heard, respected, and celebrated. We believe that by embracing and promoting inclusivity, we not only uphold our values but also strengthen our position as the CDMO of Choice in regenerative medicine solutions. We recognize that cultivating a growth mindset is essential to our success, and we are dedicated to continuous learning and improvement in our , equity, and efforts. Through accountability and action, we strive to create an environment where individuals can thrive, innovate, and contribute their unique perspectives to drive our collective success.

Montagu Private Equity (“Montagu”), a leading European private equity firm, acquired RTI in 2020 and has supported the transformation of the company to its next level of potential.

RESPONSIBILITIES:

• Serves as a core team member of cross-functional project teams whose responsibilities include conducting studies for the development of processes
• Performs standard scientific assignments to evaluate results for validity and conformance to acceptable scientific methods
• Participates in and consults with the internal and external scientific community to maintain a state-of-the-art knowledge for application to achieving successful experimental outcomes
• Coordinates and performs validations and documents risk management activities to support regulatory submissions or product launches
• Provides ownership of Design Transfer deliverables required to support both new product development projects and design change projects
• Applies experimental and theoretical techniques to achieve project specific objectives
• Reviews and edits internal documentation for team members and assists in the preparation and presentation of materials for internal or external technical reviews
• Other duties as assigned

REQUIREMENTS

Education:

Bachelor of Science Degree in a relevant discipline

Experience:

4-6 years of relevant medical device, pharmaceutical, or other regulated industry experience

Skills:

• Design Transfer within new product development in a medical device environment
• Excellent verbal and written communication
• Project Management
• Laboratory Testing
• Microsoft Office Suite
• Design software