Senior Operations Engineer in Alachua, Florida at RTI Surgical Inc
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Job Description
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, DE., Glasgow, UK., and Marton, NZ.
Read more about this change and Evergen’s commitment to advancing regenerative medicine here: https://lnkd.in/eMSfVJkM ;
RESPONSIBILITIES
- 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.)
Working Environment
- 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.
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