Senior Manufacturing Engineer

California Job Vacancies

About the Company

Our purpose at Talis is to advance health equity and outcomes by delivering accurate infectious disease testing in the moment of need, at the point of care.

While timely diagnosis of infectious diseases is critically important to enable effective treatment, testing is primarily performed in centralized laboratories, which require samples to be shipped for processing, delaying the return of results by days. Point-of-care testing solves this problem by delivering the timely information necessary for clinical care.

To deliver our purpose we focus on three things:

• Putting customers and patients first
• Making Talis a great place to work
• Living our values to Dream Big, Share Our Screens, Serve Others, Bring Our “A” Game, and Build Trust

Position Summary

• This position will report to the Director of Instruments Manufacturing Engineering. Position will be responsible for developing and documenting robust manufacturing processes for an IVD Instrument. This position is responsible for manufacturing processes performed primarily at Contract Manufacturers.  This position will be primarily focused for Mechanical Engineering aspects of the instrument as well as be responsible Industrial Engineering aspects at Contract Manufacturer. 

Specific responsibilities include, but are not limited to:

• Develop and control efficient manufacturing processes for assembly of an IVD Instrument that will run single-use diagnostic consumables. Instrument is comprised of various optical, electro-mechanical, pneumatic, and thermal
• 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
• Help optimize the product supply chain
• Identify and procure manufacturing equipment ranging from custom manufacturing test fixtures and software systems, including appropriate validations
• 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 internal and 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.
• May be asked to support IVD Consumable Manufacturing Engineering, or other tasks as required by the company.

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

Talis offers a comprehensive health and well-being benefits programs, long-term equity incentives, time-off policies, a 401(k) retirement savings plan with an immediate Company match, Education Assistance Program, a rotating suite of snacks, Monday breakfasts, Happy Hours, other fun company events and more! Best of all, join us by working at a growing company like Talis with dedicated and collaborative employees committed to making a difference in Health Care.

Talis is proud to be an equal opportunity workplace. All aspects of employment decisions will be based on merit, competence, performance, and business needs. We do not discriminate on the basis of any status protected under federal, state, or local law. We celebrate diversity and are committed to creating an inclusive environment for our colleagues.

More About Talis:

Built on a foundation of world-class science and engineering, we are developing the Talis One platform, a sample-to-answer, cloud-enabled molecular diagnostic platform that could be rapidly deployed to distributed diagnostic settings in the United States and around the world to diagnose infectious disease at the point-of-care. The Talis One platform comprises a compact instrument, single-use test cartridge, and innovative software including a central cloud database. This system is designed to provide central laboratory levels of accuracy and be operated by an untrained user.

Talis has raised more than $500 million to date and went public in February 2021. We were granted Emergency Use Authorization by the FDA for our Talis One^TM COVID-19 Test System in November 2021 and are in further testing stages and preparations for commercial rollout. 

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