Senior Manufacturing Process Development Engineer

Alembic LLC is a startup company designing and manufacturing medical devices that help treat neurovascular disease. We have already successfully launched and sold a product to Global 500 medical device company with CE mark and 510(k) clearance. The company is in the heart of the Silicon Valley (5 minutes away from downtown Mountain View). We have a unique business set up and the Job offer comes with stock options.

Senior Manufacturing Process Development Engineer

Responsibilities:

• Generates and reviews validation protocols and reports applicable to new product development and production.
• Applies technical knowledge and statistical tools to develop, characterize, and optimize processes.
• Assesses process capabilities, prioritizes process improvement opportunities, and innovates and implements process improvements on new products and production.
• Trains and/or provides work direction to product builders when required as part of engineering builds and validation activities.
• Optimizes manufacturing efficiency by analyzing and planning workflow through lean principals.
• Provides Design for Manufacturability (DFM) input to product development team and production.
• Provides technical leadership in process validation activities and master validation plans, IQ, OQ, PQ, and equipment software validations.
• Assesses process capabilities and innovates and implements process improvements on multiple and moderately complex processes as part of production and new product introductions.
• Serves as a key contributor and participant in technical reviews.
• Typically serves as a core team member or SME (subject matter expert) on new product development processes. Contributes to team effort by accomplishing related results as needed.
• Ensures proper documentation is completed to meet quality systems requirements. (e.g., BOM’s, DMR’s, Routers, Process Instructions, FMEA’s, etc.); Generates documentation changes/justification through DCO process.
• Supports new product development activities and product manufacturing transfer into production.
• Plans, organizes, and supports all aspects of technical reviews. Oversees engineering builds using special work requests.
• Able to develop tooling fixtures and equipment through suppliers to aid in process manufacturability. Comply with policies, guidelines, training and regulatory requirements per Quality System, Design Control, and government (e.g. FDA, CE, etc.) regulations.

Skills/Requirements:

• BS in Engineering/Technical field; 5-10 years Medical Device experience minimum required. 
• Must have hands-on experience in process validation activities including IQ, OQ, PQ and tooling qualifications. 
• Must have catheter manufacturing experience preferably from development through and including commercialization.
• History of success in being able to conceptualize, design, assemble and debug tooling; optimize existing and new manufacturing processes.
• Strong documentation skills, familiar with Regulatory requirements.
• Proven results in reducing product cost.
• Must have strong verbal and written communication skills.