R&D Engineer II or Senior R&D Engineer - Medical Devices, Startup

R&D Engineer II or Senior R&D Engineer

Overview

Seeking a hands-on R&D Engineer to join a 30-person medical device start-up company that's developing innovative surgical implant and delivery systems for GI Applications. The company successfully commercialized its first-generation platform and is continuing to invest heavily in next-generation product development, creating a unique opportunity to work on both commercial products and future technologies.

This position offers broad exposure to the full product development lifecycle, including concept development, mechanical design, prototyping, testing, design verification, manufacturing transfer, and commercial product support. The ideal candidate is a hands-on engineer who enjoys solving challenging technical problems in a fast-paced, collaborative medical device environment.

Responsibilities

The successful candidate will:

• Participate in the design, development, and commercialization of innovative implantable and minimally invasive surgical devices.
• Create and maintain 3D CAD models, assemblies, and detailed engineering drawings using SolidWorks.
• Design mechanical components and assemblies for manufacturability, reliability, and ease of assembly.
• Contribute to the development of injection molded plastic components and other manufactured parts.
• Generate and evaluate product concepts through prototyping and bench testing.
• Develop test methods, fixtures, and protocols to support product characterization and design verification activities.
• Analyze data and translate results into informed engineering decisions.
• Support design control activities including risk management, design verification, validation, and engineering documentation.
• Collaborate with manufacturing, quality, regulatory, clinical, and supplier partners throughout the product lifecycle.
• Support commercialization efforts through product improvements, sustaining engineering activities, and manufacturing scale-up initiatives.
• Participate in brainstorming sessions and contribute to the development of intellectual property.

Minimum Qualifications

• Bachelor's degree in Mechanical Engineering, Biomedical Engineering, or related engineering discipline.
• 2-5 years of medical device product development experience within a regulated environment.
• Strong proficiency with SolidWorks or equivalent 3D CAD software.
• Experience creating engineering drawings and design documentation.
• Hands-on experience with prototype development, product testing, and engineering problem solving.
• Working knowledge of medical device design controls, risk management, and verification/validation activities.
• Strong written and verbal communication skills.
• Ability to work independently while contributing effectively within a cross-functional team environment.

Preferred Qualifications

• Experience designing injection molded plastic components.
• Experience with minimally invasive, laparoscopic, endoscopic, catheter-based, or robotic surgical devices.
• Experience developing implantable medical devices.
• Familiarity with design for manufacturing (DFM) and design for assembly (DFA) principles.
• Experience working with external suppliers, contract manufacturers, and tooling vendors.
• Experience in a small company or startup medical device environment.
• Familiarity with rapid prototyping techniques including 3D printing, machining, and fixture development.
• Exposure to nitinol components, magnets, or other advanced medical device materials.

Why This Client:

This is an opportunity to join a smaller but commercial-stage medical device company where engineers have meaningful ownership and visibility. Team members contribute directly to products currently being used in patients while helping shape the next generation of surgical technologies. This role provides a unique combination of early-stage innovation, commercial product support, and career growth within a highly collaborative engineering environment.

On-Site Position (4-5 days/week)

Local Candidates Preferred, however some assistance may be offered for well-qualified candidates

No H1B or Visa Sponsorships - must have US Work Authorization, or be a US Citizen