Preclinical V&V Specialist (34669)

Job DetailsJob Location: Jacksonville, FL 32246Position Type: Full TimeEducation Level: 4 Year DegreeJob Shift: 8:00am - 5:00pmWho We Are

At KLS Martin, we offer a unique opportunity to contribute to the success of a dynamic and thriving company whose products are used daily across the world to help surgical patients.

The KLS Martin Group is a worldwide leader in creating surgical solutions for the craniomaxillofacial and cardiothoracic fields. Surgical innovation is our passion, and we are constantly working with surgeons to improve surgical care for their patients. Our product portfolio includes titanium and resorbable implants for reconstruction, innovative distraction devices to stimulate bone lengthening, over 4,000 surgical instruments, and other surgical products designed specifically for CMF and cardiothoracic surgeons.

KLS Martin is an innovative leader in the treatment of CMF deformities and trauma cases. We use Individual Patient Solutions (IPS) by using our proprietary IPS products where CT scans are used to custom design implants that are created specifically for that individual patient. This technology allows our surgeons to provide the best-in-class treatment for their patients.

KLS Martin Guiding Principles

Established, Privately Held Business Group – Responsive to customers, not shareholders. KLS Martin has manufactured medical products since 1896, and we have sold our products in the United States under the KLS name since 1993. We have always been, and always will be, privately owned.
Patient Focus – We design products with the patient in mind – CMF, Thoracic & Hand
Product to Table – Integrated planning, design, manufacturing and distribution process
Educational Partner – Our primary focus for support is on education
Inventory Alliance – Inventory management is critical to patient treatment/outcome
Surgical Innovation is Our Passion – More than just a tagline

What We Offer

We provide full-time employees with a competitive benefits package, including paid parental leave
In-house training and professional development opportunities
A culture of creativity and innovation by drawing on diverse perspectives and ideas to drive surgical innovation

LOCAL REMOTE ONLY - Must be within 50 miles of Jacksonville, FL due to occasional in-house meetings

Job Summary

The Regulatory V&V Specialist is responsible for assisting completing of verification and validation activities for products in development and review of design & process changes. This role works under the advisement of the Preclinical V&V Manager to ensure that products meet design specifications, regulatory requirements, and user needs prior to clinical trials and market release. The specialist will coordinate cross-functional activities with R&D, Quality Assurance, Regulatory Affairs, and external testing partners to execute robust V&V strategies. Exercises discretion and independent judgement related, but not limited to, domestic and international regulatory submissions and interfacing with regulatory authorities on the submissions.

Essential Functions, Duties, and Responsibilities

Assist with the planning, execution, and documentation of V&V activities for medical devices.
Develop V&V protocols, test plans, and reports aligned with design control and risk management processes.
Collaborate with cross-functional teams to ensure V&V activities are integrated into the product development lifecycle.
Ensure compliance with applicable standards (e.g., ISO 10993).
Manage external labs and contractors performing biocompatibility, environmental, and performance testing.
Support regulatory submissions by providing V&V documentation and addressing regulatory queries.
Identify and mitigate risks related to product safety, performance, and usability.
Maintain traceability between requirements, testing, and risk analysis documentation.
Participate in design reviews and provide feedback on testability and compliance.
Support technology transfer from R&D to manufacturing through validated processes.
Execution of biological safety evaluations of medical devices according to ISO 10993, including gap assessment activities
Ensure compliance to product documentation with respect to Biocompatibility, Manufacturing Processes, Sterilization, Packaging and/or Cleaning Validation information
Compile/write/review Biocompatibility Test Plan, Test Report and Risk Assessment of medical devices in accordance with regulatory requirements (ISO, FDA, GLP)
Develop Toxicology/Biocompatibility Risk Assessment Strategies and write the Toxicological Risk Assessment report in collaboration with other team members
Collaborate with associates of diverse technical backgrounds and partners with Regulatory Affairs, Quality Engineering, Manufacturing, Packaging and Project Teams, to achieve desired project outcomes
Coordinator for outsourced studies
Continually review the scientific literature to keep current with new technical information
Assesses product change requests for impact on biocompatibility impact
Builds strategic partnerships to further departmental and organizational objectives
Maintains positive and cooperative communications and collaborations
Performs other related duties and responsibilities, on occasion, as assigned

QualificationsEducational and Experience Requirements

Minimum educational requirement is a BS degree in relevant scientific disciplines, such as material science, toxicology, chemistry, biology or similar; although comparable areas of study and industry experience is considered for the position
2-4 years experience in the Medical Device Industry
Experience in Biocompatibility and familiarity with application of ISO 10993.

Experience with FDA Interactions

Previous experience leading projects and presenting recommendations based on technical inputs from multiple and varied functions

Knowledge, Skills, and Abilities

Maintains high integrity and confidentiality of company and department information
Ability to work effectively with all levels of internal and external associates, customers, and colleagues
Excellent interpersonal skills with the ability to effectively communicate at all levels internally as well as externally
Ability to follow through on issues, make informed decisions that comply with policies and procedures, complete tasks and problem-solve
Ability to work with minimal supervision
Ability to manage multiple priorities
Ability to organize and track multiple projects in a detail-oriented and self-directed manner
Ability to work both independently and within a team environment
Possess intermediate to advanced level knowledge of Microsoft Office

Skill Requirements

Typing/computer keyboard
Utilize computer software (specified above)
Retrieve and compile information
Maintain records/logs
Verify data and information
Organize and prioritize information/tasks
Operate office equipment
Verbal communication
Written communication
Research, analyze and interpret information
Investigate, evaluate, recommend action

Physical Requirements

Sitting for extended periods
Standing for extended periods
Extended periods viewing computer screen
Walking
Reading
Speaking
Hear/Listen
Maintain regular, punctual attendance
Writing

Hazards

Normal office environment

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

KLS Martin is a drug-free employer