Senior Research And Development Engineer

About the Role

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.
• Aid 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.

Qualifications

• Minimum bachelor's degree in Material Science, Bioengineering, Chemistry, or related technical discipline. Advanced degree preferred.
• 4+ years of medical device industry experience.
• 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.
• Design for Six Sigma, Risk Management techniques, Statistical Analysis methods, and Design of Experiments.
• Experience in tissue engineering and biomaterials is a plus.
• Able to travel as needed (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 10%.

Pay

Pay Range: $100,000.00 To $130,000.00 Annually
Bonus: annual eligibility $13,000.00

Equal Opportunity Statement

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.