Senior Operations Engineer

Rti Surgical Inc; Florida; On-site; USD 115,000 - 130,000; Full time

Benefits offered by this job

PTO

401(k) with company match

Holiday pay

Medical, dental, and vision insurance

Disability coverage

Job summary

Evergen is seeking a Senior Operations Engineer in Alachua, FL to validate equipment and control systems, lead manufacturing process improvements, and support CAPA initiatives. The role requires 6+ years in engineering, familiarity with Class III devices, and ISO 13485 compliance, with a strong emphasis on lean manufacturing and cross-functional leadership.

Compensation includes a salary of $115,000–$130,000 plus a potential annual bonus, with full-time employment and benefits.

Qualifications

• Bachelor’s degree in engineering or a relevant field preferred.
• 6+ years of engineering experience designing, modifying, and implementing processes and equipment.
• Experience with Class III medical devices required.
• Experience in ISO 13485 regulated environment required.

Responsibilities

• Validates equipment, understands interface and reactions of critical processes, installs and validates control systems.
• Provides manufacturing engineering support and recommendations for direct projects in assigned areas.
• Defines and implements solutions to technical problems; documents results.
• Leads development and improvement of manufacturing processes for existing and new products.
• Supports or leads CAPA and non-conformances and total project execution.
• Drives lean manufacturing, cost savings, capacity increases, and new product launches.
• Leads cross-functional teams and manages project timetables and deliverables.

Skills

Microsoft Office Suite

Advanced Excel

CAD software

Verbal and written communication

Project management

Problem-solving

Technical writing

Statistical methods

Lean manufacturing

Education

Bachelor’s degree in engineering

Tools

CAD software

Job description

If you are unable to complete this application due to a disability, contact this employer to ask for an accommodation or an alternative application process.

Senior Operations Engineer

Full-Time Alachua, FL, US

Salary Range: $115,000.00 To $130,000.00 Annually

Location: Alachua, FL

Annual CIP bonus opportunity of up to $10,000

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, Germany; Glasgow, UK; and Marton, New Zealand.

We are proud to be Great Place to Work® Certified in 2026, reflecting our commitment to creating an exceptional employee experience and workplace culture. Evergen currently has full-time career opportunities available across multiple locations.

• Paid Time Off (PTO)
• 401(k) with up to a 6% company match
• Holiday pay
• Medical, dental, and vision insurance
• Short-term and long-term disability coverage
• Responsibilities involve validating equipment, understanding the interface and reactions of critical processes, installing and validating control systems, and starting, running, and upgrading the processes
• Provides manufacturing engineering support and recommendations for direct projects in assigned areas
• Defines and implements specific solutions to technical problems, completing the tasks associated with such projects and writing reports that clearly document the results
• Leads the development and improvement of the manufacturing process for existing and new products
• Supports or leads initiation, investigation, and closure of non-conformances and corrective and action preventative actions (CAPA)
• Executes project management leadership for multiple projects including leading core team meetings, outlining timetables, reporting out to management, and being accountable for deliverables
• Supports or leads projects to incorporate capital equipment for new manufacturing lines and upgrades to existing lines
• Leads cross functional teams for projects and initiatives including lean manufacturing, cost savings, added capacity, and new product launches
• Operates within the company’s quality system to produce documentation for standard operating procedures
• Leads continuous improvement efforts by performing time studies, value stream analysis, flow analysis and other lean related tasks
• Makes recommendations and implements changes in support of the whole operations team to achieve team goals in quality, cost, delivery, and safety
• May have direct or indirect oversight of other engineers or technicians including hiring, performance management, mentoring, professional development, etc.
• Other duties as assigned

REQUIREMENTS:

Education

• Bachelor’s degree in an engineering discipline or a relevant field preferred.

Experience

• 6+ years of engineering experience in designing, modifying, and implementing processes and equipment
• Experience working with Class III medical devices required
• Experience working within an ISO 13485 regulated environment required
• Education requirements may be substituted for additional years of experience

Certification

• N/A

Skills

• Microsoft Office Suite, advanced Excel
• Computer Aided Drafting (CAD) software
• Excellent verbal and written communication skills
• Project management
• Problem-solving methodologies
• Technical writing
• Statistical methods and analysis
• Lean Manufacturing Practices

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.)
• 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.