Senior R&D Engineer

Position: SENIOR R&D ENGINEER (34131)
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 Senior R&D Engineer 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, 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.

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 clinical 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.

Continuous Improvement: Drive continuous improvement…