A great opportunity to be a part of a startup culture without typical startup funding concerns. 

Please review Basic Qualifications, if you meet Basic Qualifications submit your resume for review and we will reach out to you for a call!

BASIC QUALIFICATIONS

+Bachelors in Engineer/Technical Field

• 5-7+ years (with Bachelors) or 3+ years (with masters) Manufacturing engineering within the Medical Device Industry

+Experience working with Disposable Medical Devices

+Must be located in a commutable distance from Mountain View, CA or able to self relocate with minimal assistance.

NICE TO HAVE'S

+Catheter Experience

+Solidworks and tooling experience

• High Volume Manufacturing Experience

POSITION RESPONSIBILITIES:

This position will support daily output and continuous improvement goals such as product cost reduction, overall product quality, cycle time reduction, product yields, production line balance and efficiency and process improvements. The individual in this position shall be hands on, a self-starter, and demonstrate the ability to lead initiatives and projects in support of production goals.

• Develop and implement new process improvements, equipment & tooling.
• Excellent understanding of product functionality and the manufacturing processes for product lines.
• Support commercialization activities of new products including process characterization and validation, equipment procurement, and capacity activities.
• Monitors and improves line yields, cycle times, and costs. Resolves production issues.
• Competent at implementing lean manufacturing processes. Optimizes manufacturing efficiency by analyzing and planning work flow through lean principals and Kaizen events.
• Work on mid-level size project with minimal supervision. Involved in content development, testing, prototype analysis.
• Assesses process capabilities; innovates and implements process improvements in production on multiple and moderately complex processes.
• Supports internal and external audit processes as a subject matter expert to auditors or audit requests.
• Investigates and proposes action plans in (FMEA) and root cause analysis.
• Performs as core team member on cross functional teams. May participate in external project; collaborate with external entities for product/material/process improvement.
• Reviews new product technology including existing or needed tooling and processes.
• Lead and perform CAPA, NCR's, DCO’s in support of production operations.
• Work with suppliers to identify new parts, materials, and equipment.
• Work with operators to resolve production line issues and improve manufacturing processes.
• Provide maintenance support for machines used to manufacture Alembic medical devices; Develop repour with equipment manufactures.
• Author process validation documentation equipment specifications, IQ, OQ, PQ, MVP to ensure regulatory compliance.
• Write & revise work instructions; train employees as required.
• Comply with policies, guidelines, training and regulatory requirements per Quality System, Design Control, and government (e.g. FDA, CE, etc.) regulations.