We are looking for a Senior Product Development Engineer who thrives in a small, fast-paced environment and wants to play a hands-on role in bringing innovative medical devices from concept to market. This is not a narrowly defined role-you will be expected to take ownership, operate across design, testing, and development activities, and directly influence product and process outcomes.

Key Responsibilities:

• Lead product development efforts from early concept through commercialization with a strong focus on execution.
• Design and iterate components and assemblies using SolidWorks with minimal oversight.
• Develop, build, and troubleshoot prototypes and test setups in a hands-on manner.
• Design and qualify equipment (IQ/OQ/PQ) to support both development and early manufacturing.
• Work closely with Manufacturing, Quality, and Regulatory to ensure practical, compliant solutions.
• Identify issues quickly and drive resolution without relying on large support teams.
• Generate and maintain design control documentation in alignment with FDA and ISO requirements.
• Support design transfer and early production, including time on the manufacturing floor.

What We're Looking For:

• An engineer who is comfortable operating with limited structure and high ownership.
• A practical problem-solver who can balance speed with quality and compliance.
• A team player who communicates directly and effectively in a small group setting.

Qualifications:

• Bachelor's or Master's degree in Mechanical Engineering, Biomedical Engineering, or similar.
• 5+ years of product development experience, ideally in the medical device industry.
• Strong proficiency in SolidWorks.
• Experience with equipment design and qualification (IQ/OQ/PQ).
• Working knowledge of design controls and FDA/ISO 13485 requirements.
• Demonstrated success in a small company, startup, or similar resource-constrained environment.

Preferred Experience:

• Experience with catheter-based or minimally invasive devices.
• Familiarity with processes such as extrusion, bonding, and assembly of disposable medical devices.
• Experience supporting early manufacturing scale-up.