Posted in General Business 17 days ago.
Type: Full-Time
Job Details
Job Location: Manufacturing - Jacksonville, FL
Position Type: Full Time
Salary Range: Undisclosed
Job Shift: Day
Description
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
What We Offer
The Principal R&D Engineer will perform high level engineering work requiring recognized expertise. This role is responsible for developing new products from concept to commercialization. This includes research, planning, idea creation and realization, concept development, specification generation, maintenance of existing product designs, testing for verification and validations, as well as effective communication with team members, management, and customers. As project responsibilities increase, the R&D engineer will be expected to provide additional leadership and technical mentoring along with more cross-functional group interaction internally and externally. Participates in product development teams and is responsible for assigned engineering deliverables
Essential Functions, Duties, and Responsibilities
Product Development: Lead and actively participate in the design and development of new medical devices with significant scope or degree of difficulty, ensuring that they meet the highest standards of quality, safety, and efficacy. Perform research and testing on product concepts, new, and existing products. Conduct material, design and process changes to existing products by following design control processes and analyses of defects. Identify areas to streamline or improve cycle time and quality. Performs engineering activities and provides expertise to guide technical project decisions. Conducts technical design reviews as needed to support new product development.
FDA Compliance: Stay up-to-date with the latest FDA regulations, guidance documents, and industry standards related to medical devices. Apply this knowledge to develop and maintain compliant design control processes and documentation.
Regulatory Strategy: Collaborate with regulatory affairs teams to create and execute regulatory strategies for new product submissions, including 510(k) premarket notifications, PMA (Pre-market Approval) applications, and other regulatory submissions.
Design Control: Establish and manage design control procedures, including risk management, design verification and validation, design transfer, and change control processes in alignment with FDA requirements and ISO standards.
Risk Management: Identify, assess, and mitigate risks associated with product development, ensuring that risk management processes comply with FDA expectations and international standards (ISO 14971).
Cross-functional Collaboration: Work closely with cross-functional teams, including quality assurance, manufacturing, and regulatory affairs, to ensure seamless product development and regulatory compliance.
Testing: Oversee and conduct testing for verification and validation activities to demonstrate product safety, performance, and effectiveness, in accordance with FDA regulations.
Documentation and Reporting: Prepare and maintain detailed documentation of all R&D activities, including design history files, technical files, and regulatory submissions. Ensure timely and accurate reporting to regulatory authorities.
Problem Solving: Address technical challenges and issues that arise during product development, providing innovative solutions while maintaining compliance. Reviews and guides the resolution of technical issues as needed and ensures that technical work meets requirements and specifications.
Continuous Improvement: Drive continuous improvement initiatives in R&D processes and practices to enhance efficiency and effectiveness while maintaining compliance with FDA requirements.
Training and Mentorship: Provide guidance and mentorship to junior engineers and team members on FDA regulations and best practices for medical device development. Plans and assigns work / project tasks / responsibilities to personnel (typically technicians and engineers assigned to the specific project). Generally has no direct subordinates; but provides functional supervision and mentorship to project team members for the duration of project assignment and provides feedback to functional managers regarding performance of junior team members
Qualifications
Educational and Experience Requirements
KLS Martin is a drug-free employer 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
What We Offer
The Principal R&D Engineer will perform high level engineering work requiring recognized expertise. This role is responsible for developing new products from concept to commercialization. This includes research, planning, idea creation and realization, concept development, specification generation, maintenance of existing product designs, testing for verification and validations, as well as effective communication with team members, management, and customers. As project responsibilities increase, the R&D engineer will be expected to provide additional leadership and technical mentoring along with more cross-functional group interaction internally and externally. Participates in product development teams and is responsible for assigned engineering deliverables
Essential Functions, Duties, and Responsibilities
Product Development: Lead and actively participate in the design and development of new medical devices with significant scope or degree of difficulty, ensuring that they meet the highest standards of quality, safety, and efficacy. Perform research and testing on product concepts, new, and existing products. Conduct material, design and process changes to existing products by following design control processes and analyses of defects. Identify areas to streamline or improve cycle time and quality. Performs engineering activities and provides expertise to guide technical project decisions. Conducts technical design reviews as needed to support new product development.
FDA Compliance: Stay up-to-date with the latest FDA regulations, guidance documents, and industry standards related to medical devices. Apply this knowledge to develop and maintain compliant design control processes and documentation.
Regulatory Strategy: Collaborate with regulatory affairs teams to create and execute regulatory strategies for new product submissions, including 510(k) premarket notifications, PMA (Pre-market Approval) applications, and other regulatory submissions.
Design Control: Establish and manage design control procedures, including risk management, design verification and validation, design transfer, and change control processes in alignment with FDA requirements and ISO standards.
Risk Management: Identify, assess, and mitigate risks associated with product development, ensuring that risk management processes comply with FDA expectations and international standards (ISO 14971).
Cross-functional Collaboration: Work closely with cross-functional teams, including quality assurance, manufacturing, and regulatory affairs, to ensure seamless product development and regulatory compliance.
Testing: Oversee and conduct testing for verification and validation activities to demonstrate product safety, performance, and effectiveness, in accordance with FDA regulations.
Documentation and Reporting: Prepare and maintain detailed documentation of all R&D activities, including design history files, technical files, and regulatory submissions. Ensure timely and accurate reporting to regulatory authorities.
Problem Solving: Address technical challenges and issues that arise during product development, providing innovative solutions while maintaining compliance. Reviews and guides the resolution of technical issues as needed and ensures that technical work meets requirements and specifications.
Continuous Improvement: Drive continuous improvement initiatives in R&D processes and practices to enhance efficiency and effectiveness while maintaining compliance with FDA requirements.
Training and Mentorship: Provide guidance and mentorship to junior engineers and team members on FDA regulations and best practices for medical device development. Plans and assigns work / project tasks / responsibilities to personnel (typically technicians and engineers assigned to the specific project). Generally has no direct subordinates; but provides functional supervision and mentorship to project team members for the duration of project assignment and provides feedback to functional managers regarding performance of junior team membersEducational and Experience Requirements
Dun & Bradstreet |
Dun & Bradstreet |
LifeNet Health |