Manufacturing Engineer II, Medical Devices & NPI

SI-BONE; San Jose (CA); On-site; USD 114,000 - 130,000; Full time

Benefits offered by this job

Bonus

Stock

Job summary

SI-BONE, a growing medical device company, seeks a Manufacturing Engineer to partner with Product Development and external manufacturers. You will help build, improve, and document processes for manufacturing, packaging and labeling of sacropelvic products.

The role demands collaboration across functions, strong CAD/PLM tooling experience, and adherence to FDA QSR and ISO13485 in a fast-paced environment. Travel to supplier facilities is expected.

Qualifications

• Bachelor's degree in Manufacturing or Mechanical Engineering.
• Minimum 4 years of manufacturing engineering experience in medical devices.
• Experience with Class I/II medical devices and orthopedic implants preferred.
• Experience drafting manufacturing change documents and working in design for manufacturability.

Responsibilities

• Develop, improve, implement and document manufacturing, packaging and labeling processes.
• Collaborate with suppliers and QA/RA to ensure compliance with FDA QSR/ISO13485 and related regulations.
• Support ECN/MRB activities including root cause investigations of non-conforming materials.
• Participate in product launches and transitions to manufacturing operations.
• Assist with tools, fixtures, processes and costs optimization for zero-defect production.

Skills

Cross-functional collaboration

Time management

Initiative

Leadership potential

Education

Bachelor's Degree in Manufacturing Engineering or Mechanical Engineering

Tools

CAD

SolidWorks

Pro/ENGINEER (Creo/Parametric)

Microsoft Excel

Microsoft Access

Microsoft Project

Minitab

ERP systems (QAD)

Job description

SI-BONE, a growing medical device company, seeks a Manufacturing Engineer to partner with Product Development and external manufacturers. You will help build, improve, and document processes for manufacturing, packaging and labeling of sacropelvic products.

The role demands collaboration across functions, strong CAD/PLM tooling experience, and adherence to FDA QSR and ISO13485 in a fast-paced environment. Travel to supplier facilities is expected.