Sr. R&D Engineer

Evergen•Eden Prairie, MN

2d•Onsite

About The Position

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.

Requirements

Minimum bachelor's degree in Material Science, Bioengineering, Chemistry, or related technical discipline. Advanced degree preferred.
4+ years of medical device industry experience
At least 6 years’ engineering experience designing or modifying medical devices or implants
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.
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.

Nice To Haves

Experience in tissue engineering and biomaterials is a plus.

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.