R&D Engineer - Jacksonville

Job Description

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. Position may also have direct reports for supervision.

Products

Minimum 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
• 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

Job Requirements

• 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.

Location

• Territory Parameters: Jacksonville, FL; remote work one day a week is possible. Relocation assistance may be available.
• Acceptable Candidate Location: Jacksonville, FL