Serves as a lead core team member of a cross functional project team
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
Deploys deep knowledge of manufacturing to suggest and implement creative solutions in process development and test method creation
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
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

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

Senior Design Transfer Engineer

Key skills