KLS Martin Group
Preclinical V&V Specialist (33769)
KLS Martin Group, Jacksonville, Florida, United States, 32290
Overview
Join to apply for the
Preclinical V&V Specialist (33769)
role at
KLS Martin Group . Note: 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. 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 for CMF and cardiothoracic surgeons. 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. Guiding Principles Established, Privately Held Business Group - Responsive to customers. We have manufactured medical products since 1896 and have sold in the United States under the KLS name since 1993. 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 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 with verification and validation activities for products in development and review of design and 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 judgment related to, 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. Execute 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 Plans, Test Reports and Risk Assessments 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. Coordinate outsourced studies. Continually review the scientific literature to keep current with new technical information. Assess product change requests for impact on biocompatibility. Build strategic partnerships to further departmental and organizational objectives. Maintain positive and cooperative communications and collaborations. Performs other related duties as assigned. The above cited duties describe the general nature and level of work performed by people assigned to the job and are not intended to be an exhaustive list. Qualifications
Educational and Experience Requirements
Minimum educational requirement is a BS degree in relevant scientific disciplines (e.g., materials science, toxicology, chemistry, biology) or comparable areas of study and industry experience. 2-4 years’ experience in the Medical Device Industry. Experience in Biocompatibility and familiarity with ISO 10993. Experience with FDA interactions. Previous experience leading projects and presenting recommendations based on technical inputs from multiple functions. Knowledge, Skills, and Abilities
Maintains high integrity and confidentiality of company information. Ability to work effectively with all levels of internal and external associates, customers, and colleagues. Excellent interpersonal and communication skills at all levels. Ability to follow through on issues, make informed decisions, and solve problems. Ability to work with minimal supervision and manage multiple priorities. Organizational skills to track multiple projects in a detail-oriented and self-directed manner. Ability to work independently and in a team environment. Intermediate to advanced knowledge of Microsoft Office. Skill Requirements
Typing and computer keyboard proficiency Utilize computer software (specified above) Retrieve, compile, verify information Organize and prioritize information and tasks Verbal and written communication Public speaking/group presentations Research, analyze, and interpret information Investigate, evaluate, and recommend action Basic mathematical concepts Physical Requirements
Sitting and standing for extended periods Extended periods viewing computer screen Walking, reading, speaking, hearing 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 Additional Details
Seniority level: Mid-Senior level Employment type: Full-time Job function: Other Industries: Medical Equipment Manufacturing
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Join to apply for the
Preclinical V&V Specialist (33769)
role at
KLS Martin Group . Note: 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. 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 for CMF and cardiothoracic surgeons. 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. Guiding Principles Established, Privately Held Business Group - Responsive to customers. We have manufactured medical products since 1896 and have sold in the United States under the KLS name since 1993. 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 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 with verification and validation activities for products in development and review of design and 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 judgment related to, 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. Execute 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 Plans, Test Reports and Risk Assessments 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. Coordinate outsourced studies. Continually review the scientific literature to keep current with new technical information. Assess product change requests for impact on biocompatibility. Build strategic partnerships to further departmental and organizational objectives. Maintain positive and cooperative communications and collaborations. Performs other related duties as assigned. The above cited duties describe the general nature and level of work performed by people assigned to the job and are not intended to be an exhaustive list. Qualifications
Educational and Experience Requirements
Minimum educational requirement is a BS degree in relevant scientific disciplines (e.g., materials science, toxicology, chemistry, biology) or comparable areas of study and industry experience. 2-4 years’ experience in the Medical Device Industry. Experience in Biocompatibility and familiarity with ISO 10993. Experience with FDA interactions. Previous experience leading projects and presenting recommendations based on technical inputs from multiple functions. Knowledge, Skills, and Abilities
Maintains high integrity and confidentiality of company information. Ability to work effectively with all levels of internal and external associates, customers, and colleagues. Excellent interpersonal and communication skills at all levels. Ability to follow through on issues, make informed decisions, and solve problems. Ability to work with minimal supervision and manage multiple priorities. Organizational skills to track multiple projects in a detail-oriented and self-directed manner. Ability to work independently and in a team environment. Intermediate to advanced knowledge of Microsoft Office. Skill Requirements
Typing and computer keyboard proficiency Utilize computer software (specified above) Retrieve, compile, verify information Organize and prioritize information and tasks Verbal and written communication Public speaking/group presentations Research, analyze, and interpret information Investigate, evaluate, and recommend action Basic mathematical concepts Physical Requirements
Sitting and standing for extended periods Extended periods viewing computer screen Walking, reading, speaking, hearing 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 Additional Details
Seniority level: Mid-Senior level Employment type: Full-time Job function: Other Industries: Medical Equipment Manufacturing
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