Current Job Openings

Department: Quality
Job Title: Sr. Quality Engineer, Product Development
Location: Menlo Park, CA

Job Summary:

This position is responsible for representing the QA Department from early design stages to product implementation in manufacturing, independently developing the Quality plan and Quality strategy for each product development stage.

Duties & Responsibilities:

• Individual will be responsible for leading the development of product specifications, FMEA, standard test methods and flow, test equipment and fixturing, engineering/clinical builds.
• Create quality documentation and coordinate biocompatibility, sterilization and aging studies.
• Oversee design verification testing and lead test method improvement activities.
• Maintain contact with vendors, and provide feedback to suppliers regarding performance and compliance to specifications.
• Independently design experiments, develop protocols, perform process validations and data analysis, draw conclusions and communicate results.

Qualifications:

• BS
• Minimum of 5 years experience in medical device manufacturing and product development
• Strong knowledge of medical device GMPs and ISO standards applicable to the FDA and international regulatory agencies
• Superior time management
• Ability to work on several projects simultaneously
• Excellent communication skills