Sr. Design Transfer Engineer
Evergen
- Eden Prairie, Minnesota, United States
- Eden Prairie, Minnesota, United States
About
Full-Time Professional Eden Prairie, MN, US
4 days ago Requisition ID: 2506
Salary Range: $110,000.00 To $130,000.00 Annually
Annual CIP bonus opportunity of up to $13,000.00
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
Education
Bachelor’s degree in relevant area
Experience
6+ years of relevant medical device, pharmaceutical, or other regulated industry experience
Certification N/A
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 mindsetStrong knowledge of microbiological techniques and aseptic processing
Travel N/A
Physical Requirement
Move or lift 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.)
Onsite: Office environment with assigned workstation
Remote positions only: Home office environment with minimum distractions
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Languages
- English
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