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$110k–$130k/yr
Full-time
bachelor degree
Annual CIP bonus opportunity of up to $10,000.00
Posted 48d ago
~40 hrs/week
Responsibilities
Lead cross-functional project teams to develop processes and translate product designs into process specifications using Six Sigma methodologies. Coordinate validations, manage risk activities, and innovate manual processes into semi-automated equipment driven processes.
Requirements
Requires a Bachelor's degree in a relevant area and at least 6 years of experience in the medical device, pharmaceutical, or regulated industry. Candidates must possess strong knowledge of aseptic processing and microbiological techniques.
Full job description
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: https://lnkd.in/eMSfVJkM
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 mindset
Strong knowledge of microbiological techniques and aseptic processing
Travel
N/A
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.
Evergen is a leading Contract Development and Manufacturing Organization (CDMO) pushing the boundaries of innovation and tissue engineering to meet patient needs in regenerative medicine. We are expert partners to Original Equipment Manufacturers (OEMs), working with them to identify clinical problems and develop customized solutions that promote healing, accelerate recovery, and help prevent complications. Using our extensive portfolio of biological materials, we focus on specialized clinical segments, including plastic and reconstructive surgery, sports medicine and orthopedics, cardiac, and neurosurgery.
Our Mission is to enhance patients' lives by creating the best clinical outcomes through innovative, high-quality medical solutions.
Offices: 11621 Research Circle, Alachua, FL 32615, US · 1425 Innovation Pl, West Lafayette, Indiana 47906, US · Industriestraße 6, Neunkirchen, 91077, DE · 6455 City West Pkwy, Suite 100, Eden Prairie, Minnesota 55344, US · 3 Robroyston Oval, Glasgow, Scotland G33 1AP, GB
CDMOContract Development and Manufacturing OrganizationProduct DevelopmentOEMRegenerative MedicineSIStissue engineeringPlastic & Reconstructive SurgeryXenograftAllograft
Based on 2841 listings with disclosed salaries, most engineering jobs in Minnesota pay between $75k–$165k per year. Individual offers vary with seniority, company size, and specialization.
How many Engineering jobs are open in Minnesota right now?
There are currently 5,092 open engineering positions in Minnesota listed on Clera. New openings are added daily as companies post roles.
Which companies are hiring for Engineering roles in Minnesota?
Companies currently hiring include Mayo Clinic, UnitedHealth Group, Boston Scientific, Abbott, Cirrus, among others. Browse the listings above to see every active employer.
Are there remote or hybrid Engineering jobs in Minnesota?
Yes — 1153 of the 5092 open engineering positions offer remote or hybrid work (274 remote, 879 hybrid).
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