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As Senior R&D Engineer, you will take full ownership of the technical execution for internal and contract product development projects. This is a high-impact role within the U.S. R&D organization, where you will be expected to champion innovation, navigate complex regulatory landscapes, and ensure the delivery of market-leading products through disciplined project leadership

RESPONSIBILITIES

• Acting as a SME, champions complex product development projects: researching, developing, and securing regulatory approval for new regenerative medicine products.
• Actively engage and collaborate on global cross functional product development teams.
• Medical Device Design Control and Risk Management:
  • Leveraging a high level of experience and skill, independently draft/author all typical design control documentation in accordance with relevant internal SOPs such as: trace matrices, design verification plans and reports, risk documentation, design validation plans and reports, usability reports, final product labeling (including IFUs).
• Identify and lead interactions with external vendors such as test labs (e.g. biocompatibility, animal study, and analytical) and suppliers.
• Independently author engineering reports and presentations as required to document and communicate findings.
• Applies deep knowledge and experiences from across multiple clinical segments to research, develop, and formulate new products/prototypes to develop innovative solutions to satisfy customer needs
• Independently design, execute, compile data, and draw conclusions for complex experimentation.
• Assist with clinical/user needs assessments.
• Assist with intellectual property searches and evaluations.
• Ensure compliance with regulatory and industry standards (FDA, MDD/MDR, ISO, ASTM, etc.) as appropriate.
• Supports process engineering efforts during process scale-up and manufacturing improvement initiatives.
• Maintain a safe work environment and laboratory notebooks.
• May mentor or supervise less experienced engineers, interns, and co-ops.
• Other duties as reasonably assigned by the management team.

REQUIREMENTS:

Education

Experience

Skills 

• Demonstrated mastery level knowledge with:
• Tissue engineering, biomaterials, and polymers.
• Design controls.
• Risk management and creating risk analyses.
• Laboratory prototyping.
• Safety precautions and protocols for safe handling and the disposal of hazardous agents, re-agents, chemicals, and materials.
• Effective engineering problem solving tools.
• QMS change control.
• Thorough understanding of Design for Six Sigma, Risk Management techniques, Statistical Analysis methods, and Design of Experiments. Able to apply techniques and independently interpret results.
• Experience in tissue engineering and biomaterials is a plus.
• Ability to travel as needed (<20%) within the US and globally.
• Exceptional organizational, communication (verbal and written) and interpersonal skills.
• Works independently with general direction and minimal supervision.
• Attention to detail, effective problem solving and decision-making skills.
• Knowledge of MS project software, Outlook, MS Excel, MS Word, MS PowerPoint.

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 

COMPANY SUMMARY:

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 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 headquartered in Alachua, FL, and has manufacturing facilities in West Lafayette, IN., Eden Prairie and Glencoe, MN., and Neunkirchen, Germany.

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.