Qualifications

• Bachelor's Degree in Mechanical or Biomedical engineering or equivalent experience
• At least 5 years of engineering experience, preferably in the medical device industry
• Good written and verbal communication skills
• Familiar with FDA 21CFR820 and ISO13485 standards
• Experience with aseptic production and/or sterilization is preferred
• CQE/CQA certification helpful but not required
• Certified biomedical auditor is preferred

Responsibilities

• Assist in the design and development of new products through risk analysis and validation test plans
• Utilize statistical techniques like Gage R&R, Cpk, ANOVA, and DOE for quality assessment
• Employ problem-solving methods such as Cause & Effect diagrams and Root-Cause analysis
• Review and approve Engineering Change Orders and specifications
• Conduct internal and supplier audits to ensure compliance
• Investigate customer complaints and perform corrective actions
• Support continuous improvement projects and maintain environmental standards

Benefits

• Opportunities for professional growth and development
• Involvement in continual improvement initiatives
• Collaboration in cutting-edge medical device innovation
• Exposure to international compliance standards
• Supportive work environment with team-oriented projects