6+ years of experience in medical device, pharmaceutical, or regulated industries
Strong verbal and written communication skills
Proficient in project management and Microsoft Office Suite
Experience with design transfer and laboratory testing
Responsibilities
Lead cross-functional project teams to develop processes
Evaluate scientific results for validity and compliance
Apply six sigma methodologies to assess product design
Consult with scientific communities for experimental success
Innovate manual processes into semi-automated solutions
Coordinate validations and document risk management for regulatory submissions
Leverage expertise to identify and mitigate project risks
Benefits
Annual bonus opportunity up to $10,000
Support for quality process improvement initiatives
Onsite office environment with assigned workstation
Potential for remote work in a distraction-free home office
Full Job Description
Location: Alachua, FL
Annual Bonus Opportunity up to $10,000
RESPONSIBILITIES
Serves as a lead core team member of a cross functional project team whose responsibilities include conducting studies directed toward the development of processes
Performs standard scientific assignments to evaluate results for validity and conformance to acceptable scientific methods. Independently determines requirements and acceptance criterion associated with testing performed.
Applies deep knowledge of six sigma methodologies (process capability, SPC, etc.) to assess product design and translate them into process specifications
Participates and consults with the internal and external scientific community to maintain a state-of-the-art knowledge for application to achieving successful experimental outcomes
Deploys deep knowledge of manufacturing to suggest and implement creative solutions in process development and test method creation innovating manual hand driven processes to semi-automated equipment driven processes.
Coordinates or performs validations and documents risk management activities to support regulatory submissions or product launches
Leverages expertise across projects and specialties to effectively accomplish assignments and identify and mitigate risks within a project.
Leverages clinical and technical expertise to evaluate design and process risks and implement effective mitigation measures
Exhibits functional autonomy through creating project direction assigning design transfer deliverables required to support both new product development projects and design change projects
Reviews and edits internal documentation for team members and assists in the preparation and presentation of materials for internal or external technical reviews
May serve as a team lead and have direct reports
Supports Quality process improvement initiatives
Other duties as assigned
REQUIREMENTS
Education
Bachelor of Science Degree in relevant area
Experience
6+ years of relevant medical device, pharmaceutical, or other regulated industry experience
Certification
N/A
Skills
Excellent verbal and written communication
Project Management
Microsoft Office Suite
Design Transfer
Laboratory Testing
Design software
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
Montagu Private Equity ("Montagu"), a leading European private equity firm, acquired RTI in 2020 and has supported the transformation of the company to its next level of potential.
#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.
