Senior Manufacturing Engineer, Instrument

Position Summary

Sr Manufacturing Engineer will be responsible for developing and documenting robust manufacturing processes for an IVD Instrument.

Specific responsibilities include, but are not limited to:

• Set-up IVD pilot instrument assembly pilot line in using lean manufacturing principles
• Develop efficient manufacturing, test, and packaging processes for assembly of an IVD Instrument that will run single-use diagnostic consumables using typical Process development approaches
• Lead Mechanical design changes to ensure a manufacturable and sustainable product while maintaining component and/or PCB functionality.
• Develop manufacturing test protocols and automated test solutions to validate performance and operation of PCBAs, Electronic assemblies and electro-mechanical systems.
• Maintain design and process documentation including Item Specification, Process Instructions, BOM, Drawings, etc. Perform change management, including creation and routing of change orders, identifying appropriate process impacts, risks, and justification for change
• Plan and execute design transfer activities, including validation of equipment and processes, requirements creation, Master Validation Plans, IQ/OQ/PQ Protocols and Reports, Test Method Validation, Process Flow Diagrams, pFMEA, etc.
• Transfer manufacturing processes to external suppliers, collaborating effectively across functions to meet various customer needs, including appropriate training.
• Perform cost reduction, capacity scaling, and quality improvement activities (equipment and manpower) to meet business needs.
• Ensure compliance to Quality System Requirements within an FDA regulated manufacturing environment.
• Leverage a strong understanding of manufacturing metrics to appropriately select process indicators that quickly and effectively communicate product and process health.

Education & Experience

• BS or MS in ME, IE or equivalent
• 2-8 years' experience in process development, manufacturing, of design in the medical device industry.
• Experience using software-based manufacturing test and assembly systems
• Experience in writing and executing test plans to validate systems-based product performance and robustness.
• Demonstrated ability to understand and successfully work across multiple disciplines such as engineering, software and manufacturing highly desired.
• Specific experience with pneumatic, thermal, optical and/or electro-mechanical assembly, calibration and testing processes is desired.
• Process and design development experience that includes exposure to the design and manufacturing of pneumatic pumps, motors, heaters, optics
• Experience with time-studies, discrete event simulations, failure analysis and lean line set-up and management
• Experience working with and auditing Contract Manufacturers
• A solid understanding of US and EU regulatory requirements for medical devices is necessary. Familiarity with ISO requirements.
• Ability to write and execute IQ/OQ/PQ's for new manufacturing equipment and processes
• Strong "hands-on" capability in the installation and deployment of processes and equipment into manufacturing.
• Must demonstrate strong analytical and problem-solving capabilities, excellent oral and written communication skills, and a high level of organizational ability.
• Leadership skills, including ability to organize, clarify and influence others.
• Proficiency in MCAD and PLM systems

This role is open in Redwood City, CA; Chicago, IL; or Southern California

Salary Target for CA: $117k to 130k