LEAD3R is looking to speak with Design Engineerswho have a medical device backgroundto join our global life sciences client in Fort Lauderdale, FL. The Senior Design Engineer is responsible for leading and executing complex design projects for medical devices. This role requires a deep understanding of engineering principles, medical device regulations, and manufacturing processes. The ideal candidate will be a creative problem solver with a strong track record of delivering innovative and high-quality medical device designs.
Key Responsibilities
- Design Leadership: Lead cross-functional design teams to develop innovative medical device concepts, ensuring alignment with product requirements, regulatory standards, and manufacturing capabilities.
- Technical Expertise: Apply advanced engineering principles and methodologies to design and optimize medical device components and systems, considering factors such as biocompatibility, functionality, and reliability.
- Regulatory Compliance: Ensure that all medical device designs comply with relevant regulatory standards, including FDA, ISO, and other applicable requirements.
- Risk Management: Conduct risk assessments to identify and mitigate potential hazards associated with medical device designs, ensuring patient safety and product quality.
- Manufacturing Collaboration: Work closely with manufacturing engineers to optimize designs for manufacturability, cost-effectiveness, and scalability.
- Project Management: Manage design projects from concept to commercialization, including planning, scheduling, budgeting, and resource allocation.
- Mentorship: Provide technical guidance and mentorship to junior engineers, fostering a culture of innovation and continuous learning.
Qualifications
- Bachelor's degree in Mechanical Engineering, Biomedical Engineering, or a related field.
- Minimum 8 years of experience in medical device design and development.
- Strong understanding of engineering principles, including materials science, mechanics, and thermodynamics.
- Proficiency in CAD software (e.g., SolidWorks, AutoCAD) and engineering analysis tools (e.g., FEA, CFD).
- Knowledge of medical device regulatory requirements (e.g., FDA 21 CFR, ISO 13485).
- Experience with design control processes and documentation.
- Excellent problem-solving, analytical, and communication skills.
- Ability to work effectively in a fast-paced, collaborative environment.
Preferred Qualifications
- Advanced degree in engineering or a related field.
- Experience with specific medical device technologies (e.g., implants, diagnostics, therapeutic devices).
- Certifications in engineering or quality management.
If you or someone you know may be interested, please send your resume to Lisa.Oster@Lead3r.com or visit Lead3r.com to learn more about us. #LifeSciences #LEAD3Rjobs #LEAD3R
