Product Engineer, Medical Devices

Location: Dobbs Ferry, NY

Employment Type: Full-Time In Person

Experience Level: 3-5 years

About Us:

We are a dynamic, mission-driven medical technology company focused on creating innovative solutions that improve patient care and clinical outcomes. We are experts in bringing new medical technologies to market, from ideation to commercialization. Our product portfolio includes cutting-edge wearable technologies and interventional surgical devices. Join our team and help shape the future of medical technology in a fast-faced, growing start-up.

Job Summary:

We are seeking an experienced and versatile Mechanical or Biomedical Engineer (or related field) with a strong background in product development. Experience in Wearable Products and/or interventional medical devices a plus. This role spans early concept development, prototyping, and regulatory compliance through production, with opportunities to influence cross-functional innovation.

Key Responsibilities:

• Design and develop mechanical components and assemblies for wearable products and interventional medical devices (e.g., single-use disposable surgical instruments).
• Collaborate with electrical and firmware engineers to integrate sensors, Bluetooth modules, and PCBs into compact and user-friendly form factors.
• Conduct CAD modeling, tolerance analysis, and design-for-manufacturing (DFM) for high-precision, body-contact components.
• Prototype and test devices for comfort, durability, and performance under real-world conditions.
• Participate in risk analysis, verification/validation, and regulatory documentation in compliance with FDA and ISO standards.
• Contribute to cross-disciplinary discussions on product architecture, including electronics packaging and connectivity.

Qualifications:

• B.S. or M.S. in Mechanical or Biomedical Engineering or a related field.
• Minimum 3 years of experience in mechanical design for wearable products and/or medical devices.
• Proficiency in 3D CAD (e.g., SolidWorks, Creo) and familiarity with prototyping methods.
• Strong understanding of materials and processes for medical-grade, body-contact components.
• Familiarity with FDA and ISO medical device standards (e.g., ISO 13485).

Nice to Have:

• Experience working with wearable sensors and connected systems including Bluetooth integration in product development.
• Experience with Class II medical devices.
• Background in a variety of prototyping and manufacturing processes. Including soft goods or flexible materials for wearables. Plastic injection molding and metal work for surgical instruments.

What We Offer:

• A collaborative, innovative environment with your ideas making direct meaningful impact on patient care
• Engagement directly with physicians, surgeons, and patients during product development
• Competitive compensation
• Opportunities to work on a wide range of device technologies from concept through launch

Pay: From $100,000.00 per year

Benefits:

• 401(k)
• Health insurance
• Paid time off

Work Location: In person