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 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.

The above cited duties and responsibilities describe the general nature and level of work performed by people assigned to 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.

Educational and Experience Requirements

• BS in Engineering (Mechanical, Bioengineering, Biomedical) or comparable technical/medical field required
• Master’s degree in engineering (Mechanical, Bioengineering, Biomedical) or comparable technical/medical field strongly preferred
• Thorough understanding of FDA regulations, including 21 CFR Part 820 (Quality System Regulation) and 21 CFR Part 807 (Establishment Registration and Device Listing).
• Experience with ISO 13485 and ISO 14971 standards is highly desirable.
• Proficiency in risk management, design control, mechanical testing and product development processes.
• Strong problem-solving skills and the ability to work effectively in cross-functional teams.
• 5-7 years engineering experience in design and development, medical device preferred
• Prior experience with 3D CAD modeling software such as Solidworks, Freeform
• GD&T experience applied to engineering drawing
• Proficient user of Microsoft Office applications
• Prior Windchill experience would be a plus

Knowledge, Skills, and Abilities

• Adhere and support KLS Martin’s quality and safety policies and procedures.
• Ability to learn new software quickly.
• Ability to retrieve and interpret documentation.
• Able to work independently under minimal supervision and accomplish goals.
• Able to efficiently communicate and collaborate amongst a team.
• Strong interpersonal skills with the ability to effectively communicate at all levels internally, as well as externally.
• Problem solving & decision making
• Strong communication skills, both written and orally

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
• Advanced mathematical concepts (fractions, decimals, ratios, percentages, graphs)
• Verbal communication
• Written communication
• Public speaking/group presentations
• Research, analyze and interpret information
• Investigate, evaluate, recommend action
• Basic mathematical concepts (e.g. add, subtract)
• Abstract mathematical concepts (interpolation, inference, frequency, reliability, formulas, equations, statistics)

Physical Requirements

• Sitting for extended periods
• Extended periods viewing computer screen
• Walking
• Reading
• Speaking
• Hear/Listen
• Maintain regular, punctual attendance
• Lifting/carrying up to 20 pounds various items
• Repetitive Motions
• Pushing/Pulling
• Bending/Stooping
• Reaching/Grasping
• 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