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Senior Manager of Cartridge Development

Organization

Talis Biomedical

Job Location

230 Constitution Dr.
Menlo Park, CA 94025
United States

Job Description

Company Overview

Talis is an exciting biomedical company that just completed an IPO on February 12, 2021! We have developed an innovative, proprietary, point-of-care molecular diagnostics platform. We have also recently developed a rapid COVID-19 assay test that runs on this platform.  Enabling rapid testing across a wide range of healthcare settings, Talis is growing quickly. Come and join us to make a significant impact during this public health crisis and beyond. Contribute and be a significant team member as we develop other assays and launch other pipeline products in the infectious disease area.

Our visionary team combines depth of experience with a passion to deliver. Our pioneering tests are designed to enable caregivers to quickly detect infectious organisms and enable individualized care. From the doctor’s office to the hospital bedside, to remote care settings, we are redefining the treatment of infectious diseases.

Talis is committed to excellence in advancing improved health outcomes. This commitment, along with a dynamic team culture, drives our mission to develop and commercialize novel approaches.

Summary of Position

The Development Cartridge Lead is responsible for leading consumable development activities on the Talis One platform.  This individual will be responsible for taking cartridge design and testing from the end of feasibility through design transfer to manufacturing.  In a rapidly growing startup setting, this will require confidence in design, manufacturing techniques, risk assessment activities, failure analysis.  This work will require consistent collaboration with other members of the engineering team, and communication to stakeholders including research, operations, and quality, along with contract manufacturers.  This position will supervise  3-4 direct reports.

A successful candidate will have a range of experience in manufacturing, basic physics, and the medical device industry.  You will need to be a self-starter who can draw on their prior knowledge to fine-tune cartridge designs, triage issues, and design experiments, all while keeping rigorous documentation.  You will need to draw on your experience designing medical devices, along with a fundamental knowledge across biology, heat transfer, mechanics, fluidics, and materials science.  Most importantly, you should be a motivated, creative, and self-sufficient critical thinker.

Responsibilities

  • Lead design improvements to existing and post-feasibility Talis products for reliability improvements and cost reduction and make modifications to adapt Talis consumables to new assays.
  • Coordinate work of the Cartridge Development, and work with Platform Development Stakeholders to maintain and execute on a roadmap of feature improvements
  • Support verification, validation, and design transfer
  • Contribute to design history file of consumables, manage design controls and lead design reviews.
  • Serve as consumables subject matter expert in collaboration with biology, instrument, commercial and operations teams.
  • Design and build test instruments and procedures for analysis of consumables and subcomponents.
  • Communicate technical and project status updates to technical leadership and executive management
  • Mentor and manage 3 or more engineers.

Qualifications

  • MS with 7+ years or Ph.D. with 4+ years of failure analysis experience in a medical device setting.
  • Understanding of molecular biology/diagnostic systems, especially products utilizing nucleic acid amplification and microfluidics.
  • Strong experience with solid modeling CAD (SolidWorks preferred) along with CAD-specific PDM.
  • Experience with manufacturing techniques such as injection molding, laser, and ultrasonic welding, die-cutting, laser cutting,
  • Data-driven, proficient with the design of experiments (DOE), statistical analysis, statistical process control (SPC), failure modes and effects analysis (FMEA), and best practices for medical device documentation
  • Good working knowledge of best practices for documentation of medical device failures in an ISO 13485 environment.
  • Experience building mechanical test fixtures.
  • Knowledge of a broad range of metrology and characterization equipment such as SEM, profilometry, GC-MS, fluorescent microscopy, CT, colorimetry, etc.
  • Strong organizational skills, managerial experience, and attention to detail
  • Effective verbal and written communication skills with the ability to articulate complex technical ideas in a multidisciplinary environment.

 

Talis offers excellent health and welfare benefits, stock options, a 401(k) program with immediate Company match, 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.