Senior Medical Device Manufacturing Engineer

SI-BONE, Inc; San Jose (CA); Sur place; USD 114 000 - 130 000; Plein temps

Avantages offerts par ce poste

Bonus

Stock options

Résumé du poste

SI-BONE, Inc in San Jose, CA is seeking a Manufacturing Engineer to collaborate with Product Development and suppliers to develop and document processes for manufacturing, packaging and labeling of medical devices. You will support change controls, quality systems, and regulatory compliance while traveling to supplier facilities as needed. This role requires 4+ years in manufacturing engineering for medical devices and experience with FDA QSR/ISO13485 environments.

Qualifications

• Bachelor’s degree in Manufacturing or Mechanical Engineering.
• 4+ years in manufacturing engineering for medical devices.
• Experience with Class I/II medical devices preferred.
• Familiar with QA/QC, FDA QSR and ISO13485 is a plus.

Responsabilités

• Collaborate with Product Development and suppliers to create and document manufacturing processes.
• Support DFMEA/DFX activities and change controls.
• Develop and maintain SOPs, work instructions, and inspection documentation.
• Create tool drawings and orders in line with QA/RA requirements.
• Work with cross-functional teams on packaging, labeling, and GTINs.

Connaissances

NPI experience

Product launch exposure

Cross-functional collaboration

Statistical methods (ANOVA/DOE)

Time management

Communication skills

Formation

Bachelor’s degree in Manufacturing/Mechanical Engineering

Outils

CAD (SolidWorks/ProE)

Minitab

ERP systems (QAD)

Microsoft Excel

Microsoft Access

Microsoft Project

Description du poste

SI-BONE, Inc in San Jose, CA is seeking a Manufacturing Engineer to collaborate with Product Development and suppliers to develop and document processes for manufacturing, packaging and labeling of medical devices. You will support change controls, quality systems, and regulatory compliance while traveling to supplier facilities as needed. This role requires 4+ years in manufacturing engineering for medical devices and experience with FDA QSR/ISO13485 environments.