Design Engineer

Welcome to Occam Design. Meeting your specs, exceeding your expectations.

We are seeking a highly skilled and motivated Medical Device Design Engineer to join our team. This role involves leading the design, development, and validation of innovative medical devices, ensuring they meet all regulatory standards and deliver exceptional performance.

Qualifications:

• Bachelor’s degree in Mechanical Engineering or a related field
• Proven experience in medical device design and development, with a strong understanding of FDA regulations and ISO standards.
• Proficiency in CAD software (e.g., Solid Works, AutoCAD) and mechanical simulation tools.
• Excellent problem‑solving skills and attention to detail.
• Strong project management skills and the ability to work effectively in a fast‑paced, collaborative environment.
• Exceptional communication skills, both written and verbal.

Key Responsibilities:

• Lead the design and development of medical devices from concept to production, ensuring compliance with industry standards and regulations.
• Conduct detailed mechanical analysis and simulations to optimize device performance.
• Collaborate with cross‑functional teams, including electrical engineers, software developers, and regulatory experts, to ensure seamless integration and functionality.
• Manage project timelines, budgets, and deliverables to meet project milestones.
• Prepare and present technical reports, design reviews, and documentation for regulatory submissions.
• Stay updated with industry trends, emerging technologies, and regulatory changes to drive continuous improvement.

OCCAM Design is ISO 13485:2016 Certified and FDA Registered. As a full‑service development firm, OCCAM Design exclusively focuses on medical products and over 30 years of experience developing medical devices, combination products, and consumer healthcare products. OCCAM Design is an innovative leader in developing and manufacturing the highest quality medical devices. We are located in Louisville, Kentucky. You can contact our team  or via phone at  for more information on working with our team.

Occam Design is ISO 13485:2016 Certified and FDA Registered. As a full‑service development firm, Occam Design has an exclusive focus on medical products and over 30 years of experience developing medical devices, combination products and consumer healthcare products.

Occam Design is an innovative leader in the development and manufacturing of the highest quality medical devices.

Our capabilities and expertise, coupled with a passion for the work we do, results in on‑time and on‑budget delivery for our clients.