Sr. Design Transfer Engineer

Responsibilities

• Serves as a lead core team member of a cross functional project team.
• Conducts studies directed toward the development of processes.
• Evaluates results for validity and conformance to acceptable scientific methods.
• Determines requirements and acceptance criteria 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.
• Captures and documents risk management activities to support regulatory submissions or product launches.
• 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.

Requirements

• Bachelor’s degree in relevant area.
• 6+ years of relevant medical device, pharmaceutical, or other regulated industry experience.
• No certification required.

Skills

• 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.

Benefits

• Annual CIP bonus opportunity of up to $13,000.00.
• Global industry-leading contract development and manufacturing organization (CDMO) in regenerative medicine.
• Headquartered in Alachua, FL, and has manufacturing facilities in West Lafayette, IN, Eden Prairie, MN, Neunkirchen, DE, Glasgow, UK, and Marton, NZ.

Pay

Commensurate with experience.

Schedule

Onsite: Office environment with assigned workstation
Remote positions only: Home office environment with minimum distractions.

Physical Requirements

• Moves or lifts objects up to 25 pounds.
• Frequent (>75%) stationary position (standing or sitting) while utilizing digital displays.
• Frequent (>75%) fine manipulation using hands and fingers (typing, opening, writing, clicking, paper sorting, etc.).

Working Environment

• Onsite: Office environment with assigned workstation
• Remote positions only: Home office environment with minimum distractions

About Evergen

Evergen is a global industry-leading contract development and manufacturing organization (CDMO) in regenerative medicine. Evergen is rooted in a steadfast commitment to quality, integrity, and patient safety with a focus on five key values: Accountable, Agile, Growth Mindset, Customer-Centric, and Inclusive. Montagu Private Equity (“Montagu”), a leading European private equity firm, acquired Evergen in 2020 and has supported the transformation of the company to its next level of potential.