Sr. Design Transfer Engineer

While this is intended to accurately reflect 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). 

COMPANY 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 diversity 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 diversity and ensure that every voice is heard, respected, and celebrated. We believe that by embracing diversity 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 diversity, equity, and inclusion 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.

Areas of Responsibility

• Serves as a lead core team member of a cross functional project team whose responsibilities include conducting studies directed toward the development of processes 
• Performs standard scientific assignments to evaluate results for validity and conformance to acceptable scientific methods. Independently determines requirements and acceptance criterion associated with testing performed.
• Applies deep knowledge of six sigma methodologies (process capability, SPC, etc.) to assess product design and translate them into process specifications
• Participates and consults with the internal and external scientific community to maintain a state-of-the-art knowledge for application to achieving successful experimental outcomes 
• Deploys deep knowledge of manufacturing to suggest and implement creative solutions in process development and test method creation innovating manual hand driven processes to semi-automated equipment driven processes.
• Coordinates or performs validations and documents risk management activities to support regulatory submissions or product launches 
• Leverages expertise across projects and specialties to effectively accomplish assignments and identify and mitigate risks within a project.
• Leverages clinical and technical expertise to evaluate design and process risks and implement effective mitigation measures
• Exhibits functional autonomy through creating project direction assigning design transfer deliverables required to support both new product development projects and design change projects
• Reviews and edits internal documentation for team members and assists in the preparation and presentation of materials for internal or external technical reviews 
• May serve as a team lead and have direct reports
• Supports Quality process improvement initiatives 
• Other duties as assigned 

Minimum Requirements

Bachelor of Science degree in engineering or related field

• Able to set goals for self and work to achieve milestones.
• Able to work effectively on multiple projects simultaneously
• Experience with application of statistical methods (DOE, t-test,
• ANOVA, confidence limits, tolerance intervals)
• Able to operate statistical software such as JMP or Minitab
• Excellent written, verbal, and organizational skills
• Excellent record keeping and documentation skills
• Sufficient background to generally understand medical and biotechnology terminology
• Experience effectively mentoring and leading teams on complex projects 
• Proficient in Microsoft Office Suite (Excel, Word, Project, PowerPoint) 
• 6 years of relevant medical device, pharmaceutical, or other regulated industry experience 
• Less than 10% travel

Physical Requirements/Work Environment

• Must be able to perform the essential functions of the job, with or without reasonable accommodations
• Willing to work with material derived from animal tissues
• Limited exposure to hazardous chemicals and/or biohazards
• Physical demands are typical of an office environment