Sr. Design Transfer Engineer

Evergen • Alachua, FL

1d • Onsite

About The Position

Evergen is seeking a Sr. Design Transfer Engineer to support design transfer and process development for regenerative medicine products. The role serves as a lead core team member on cross-functional projects and conducts studies to develop processes. It applies scientific methods, Six Sigma, and manufacturing expertise to evaluate product designs, establish process specifications, develop testing methods, and improve processes, including transitioning manual processes to semi-automated equipment-driven processes.

The engineer coordinates or performs validations and documents risk-management activities supporting regulatory submissions and product launches. The role evaluates design and process risks, develops mitigation measures, and independently establishes project direction and design-transfer deliverables for new product development and design-change projects. It also reviews team documentation, supports technical reviews and Quality process improvement initiatives, and may lead a team and have direct reports. This is an onsite role in Alachua, Florida.

Requirements

• Bachelor of Science degree in a relevant area.
• At least 6 years of relevant experience in the medical device, pharmaceutical, or another regulated industry.
• Excellent verbal and written communication skills.
• Project management skills.
• Microsoft Office Suite skills.
• Design transfer experience or skills.
• Laboratory testing skills.
• Design software skills.

Responsibilities

• Serve as a lead core team member of a cross-functional project team conducting studies directed toward process development.
• Perform scientific assignments and evaluate results for validity and conformance to acceptable scientific methods.
• Independently determine requirements and acceptance criteria for testing.
• Apply Six Sigma methodologies, including process capability and statistical process control, to assess product designs and translate them into process specifications.
• Consult with the internal and external scientific community to maintain current knowledge and support successful experimental outcomes.
• Use manufacturing expertise to develop and implement creative process-development and test-method solutions, including transitioning manual processes to semi-automated equipment-driven processes.
• Coordinate or perform validations and document risk-management activities supporting regulatory submissions or product launches.
• Apply expertise across projects and specialties to complete assignments and identify and mitigate project risks.
• Evaluate design and process risks using clinical and technical expertise and implement mitigation measures.
• Create project direction and assign design-transfer deliverables for new product development and design-change projects.
• Review and edit internal documentation and assist with preparing and presenting materials for internal or external technical reviews.
• May serve as a team lead and have direct reports.
• Support Quality process improvement initiatives.
• Perform other duties as assigned.

Benefits

• Paid time off (PTO).
• 401(k) with company match.
• Holiday pay.
• Medical, dental, and vision insurance.
• Short-term and long-term disability coverage.
• Paid parental leave.
• Annual bonus opportunity up to $10,000.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior