R&D Mechanical and Systems Engineer | Specialized in Medical Device Innovation and Reliability
As an accomplished R&D Mechanical Engineer with over two decades of expertise, I bring a robust skill set in developing high-quality, reliable, and cost-effective medical devices. My experience spans across designing, leading, and optimizing complex engineering projects that comply with regulatory standards, drive technological advancements, and improve user experiences.
Why Work With Me:
- Technical Leadership: Proven ability to lead cross-functional engineering teams, set priorities, and meet critical deadlines. Skilled in design for manufacturing (DFM), reliability (DFR), and system robustness, with a focus on cost reduction and efficiency.
- Hands-On Engineering Expertise: Extensive experience with SolidWorks, design for injection molding, optical testing, and contract manufacturing. Known for implementing Six Sigma methodologies to enhance quality and reduce production costs.
- Medical Device Specialist: Deep understanding of FDA and ISO 13485 regulations, IEC 60601-1 standards, and 510(k) compliance. Successfully led projects resulting in significant improvements in robustness, reliability, and cost efficiency.
- Innovation and Patents: Holder of 23 utility and 8 design patents, demonstrating a commitment to advancing technology and providing unique solutions in the medical device field.
Let’s collaborate to take your next project from concept to reality, ensuring the highest standards in design and execution.