Bachelor's degree in engineering or relevant field preferred.
6+ years of engineering experience in design and implementation.
Experience with Class III medical devices is required.
Experience in an ISO 13485 regulated environment is necessary.
Strong skills in Microsoft Office Suite and advanced Excel.
Responsibilities
Validate and install control systems for critical processes.
Provide manufacturing engineering support for direct projects.
Define and implement solutions to technical problems, documenting results.
Lead development and improvement of manufacturing processes for products.
Initiate and manage non-conformance investigations and corrective actions.
Execute project management for multiple initiatives, leading team meetings and reporting progress.
Support projects involving the integration of new capital equipment for manufacturing.
Benefits
Annual CIP bonus opportunity of up to $10,000.
Full Job Description
Location: Alachua, FL
Annual CIP bonus opportunity of up to $10,000
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
#LI-Onsite
About RTI Surgical Inc
RTI Surgical Holdings, Inc. is a surgical implant company. The Company processes donated human musculoskeletal and other tissues, including bone, cartilage, tendon, ligament, fascia lata, pericardium, sclera and dermal tissues, and bovine and porcine animal tissues to produce allograft and xenograft implants utilizing BIOCLEANSE, TUTOPLAST and CANCELLE SP sterilization processes, and manufactures metal and synthetic implants for distribution to hospitals and surgeons. The Company's segments include Spine, Sports Medicine, Ortho fixation, Bone Graft Substitutes and General Orthopedic (BGS and General Orthopedic), Dental and Surgical Specialties. The Company's implants are used in orthopedic, spine, sports medicine, cardiovascular, dental and surgical procedures. The Company's processing facilities are located in Alachua, Florida; Neunkirchen, Germany; and Aix-en-Provence, France. The Company distributes its implants and services in the United States and internationally.
