Sr. Design Transfer Engineer

RTI Surgical

Eden Prairie, MN

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JOB DETAILS

SKILLS

Agile Programming Methodologies, Asepsis, Biotech and Pharmaceutical, Communication Skills, Computer Workstations, Conduct Studies, Consulting, Contract Manufacturing, Cross-Functional, Design Evaluation, Detail Oriented, Diversity, Documentation, Establish Priorities, Lift/Move 25 Pounds, Manufacturing, Market Segmentation, Medical Equipment, Medicine, Microbiology, Patient Safety, People Management, Presentation/Verbal Skills, Problem Solving Skills, Process Capability, Process Development, Process Improvement, Product Design, Product Development, Product Support, Product/Service Launch, Project Design, Quality Assurance, Quality Assurance Methodology, Regulations, Regulatory Submissions, Risk Analysis, Risk Management, Six Sigma, Small Company, Supply Chain Management, Team Lead/Manager, Technical/Engineering Design, Test Plan/Schedule, Typing, Validation Testing

LOCATION

Eden Prairie, MN

POSTED

1 day ago

Location: Eden Prairie, MN

Annual CIP bonus opportunity of up to $13,000.00

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.

Read more about this change and Evergen's commitment to advancing regenerative medicine here:

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

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

Travel

Safety:

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.)

Working Environment

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

More about Evergen:

Evergen 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.

Evergen 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 Evergen, 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 Evergen in 2020 and has supported the transformation of the company to its next level of potential.

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About the Company

RTI Surgical

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