Preclinical V&V Specialist (33769)

*This role requires living within 50 miles of the KLS Martin L.P office*

Who 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
  
  

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
  
  

The above cited duties and responsibilities describe the general nature and level of work performed by people assigned to the job. They are not intended to be an exhaustive list of all the duties and responsibilities that an incumbent may be expected or asked to perform.

Qualifications

Educational 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
• Verify data and information
• Organize and prioritize information/tasks
• Verbal communication
• Written communication
• Public speaking/group presentations
• Research, analyze and interpret information
• Investigate, evaluate, recommend action
• Basic mathematical concepts (e.g. add, subtract)
  
  

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