Sr. Mechanical Engineer - Medical Device

Company Description TAS Medical, Inc. is a medical device company focused on improving surgical outcomes and reducing healthcare costs by minimizing wound dehiscence and enabling more minimally invasive procedures. The company has developed a tissue approximation kit that uses medical‑grade zip‑ties to quickly and effectively approximate soft tissue across a wide range of high‑volume surgeries. This simple yet innovative solution is designed to help save lives, shorten hospital stays, and provide measurable value to healthcare systems.

TAS Medical’s strong intellectual property portfolio supports its mission to bring safer, more efficient surgical technologies to patients and providers.

Role Description The Sr. Mechanical Engineer – Medical Device will lead the mechanical design and development of TAS Medical’s tissue approximation products and related systems. This full‑time, on‑site role in San Carlos, CA involves owning the design process from concept through verification, validation, and transfer to manufacturing, including detailed CAD modeling, tolerance analysis, and prototype development. Day‑to‑day responsibilities include collaborating with cross‑functional teams (clinical, regulatory, quality, and manufacturing), conducting design reviews, performing engineering analyses, and supporting testing for safety, reliability, and performance.

The engineer will also manage technical project plans, documentation, and risk assessments, while contributing to R&D activities such as exploring new materials, mechanisms, and product enhancements aligned with clinical needs.

Qualifications

• Strong foundation in Mechanical Engineering with experience in medical device design and development.
• Demonstrated expertise in device design, including mechanisms, materials selection, injection molding, and tolerance/DFM considerations.
• Proficiency in Computer‑Aided Design (CAD) tools (e.g., Solid Works) for 3D modeling, assemblies, and drawings.
• Experience in Project Management, including planning, scheduling, risk mitigation, and cross‑functional coordination.
• Background in Research and Development (R&D), with a track record of prototyping, testing, and iterating on novel concepts.
• Knowledge of medical device standards, regulatory requirements, and design controls (e.g., ISO 13485, FDA design control principles) is highly beneficial.
• Ability to generate clear engineering documentation, test protocols, and reports, and to communicate effectively with technical and non‑technical stakeholders.
• Bachelor’s or Master’s degree in Mechanical Engineering or a closely related discipline; prior experience in Class I/II medical devices is a plus.