Sr. Design Transfer Engineer

Evergen•Eden Prairie, MN

1d•$110,000 - $130,000•Onsite

About The Position

Evergen 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, Evergen is headquartered in Alachua, FL, and has manufacturing facilities in West Lafayette, IN., Eden Prairie and Glencoe, MN., Neunkirchen, DE., Glasgow, UK., and Marton, NZ. This role serves as a lead core team member of a cross-functional project team, conducting studies directed toward the development of processes. The position involves performing standard scientific assignments to evaluate results for validity and conformance to acceptable scientific methods, independently determining requirements and acceptance criteria associated with testing performed. It requires applying deep knowledge of six sigma methodologies to assess product design and translate them into process specifications. The role also involves participating and consulting with the internal and external scientific community to maintain state-of-the-art knowledge, and deploying 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. Coordination or performance of validations and documentation of risk management activities to support regulatory submissions or product launches are key responsibilities. The engineer will leverage expertise across projects and specialties to effectively accomplish assignments and identify and mitigate risks within a project, as well as leverage clinical and technical expertise to evaluate design and process risks and implement effective mitigation measures. The role exhibits functional autonomy through creating project direction and assigning design transfer deliverables required to support both new product development projects and design change projects. Reviewing and editing internal documentation for team members and assisting in the preparation and presentation of materials for internal or external technical reviews are also part of the duties. The position may serve as a team lead and have direct reports, and will support Quality process improvement initiatives.

Requirements

Bachelor’s degree in relevant area
6+ years of relevant medical device, pharmaceutical, or other regulated industry experience
Strong attention to detail and documentation practices
Ability to work independently in a small-company environment
Effective communication and cross-functional collaboration
Problem-solving and investigative mindset
Strong knowledge of microbiological techniques and aseptic processing

Responsibilities

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