Senior Staff Engineer, Instrumentation New Product Introduction and Sustaining

Countable Labs•Palo Alto, CA

21h

About The Position

At Countable Labs, we’re reimagining the future of genomics and we’d love for you to be a part of it! As the innovators behind our groundbreaking Countable PCR platform, we’re building tools that make a real impact in precision medicine. We’re a fast-growing startup fueled by innovation, collaboration, and a mission-driven spirit. If you’re ready to roll up your sleeves, build something from the ground up, and help shape the future of genomics, we want you on our team! The Senior Staff Systems & New Product Introduction Engineer owns the end-to-end transfer of complex opto-electromechanical systems from late-stage development through production and early field deployment, and post-launch sustaining activities. This role ensures manufacturing robustness, CDMO readiness, and system-level reliability across real-world workflows throughout product launch and early lifecycle deployment. This individual leads the identification and elimination of reliability risks across CDMO manufacturing, installation, and field use by serving as the technical bridge between field experience, internal engineering teams, suppliers, and contract manufacturers.

Requirements

Bachelor’s degree in Electrical Engineering, Systems Engineering, Mechatronics Engineering, Biomedical Engineering with bioinstrumentation focus, or related field
10+ years of experience in NPI and post-launch sustaining for bioinstrumentation that encompasses robustness, operations, manufacturing, field engineering, or systems engineering.
Demonstrated experience leading or playing a critical role in multiple new product introductions of bioinstrumentation, with a strong track record of working effectively with internal development engineers and contract manufacturers
Hands-on experience with complex opto-electromechanical systems (lasers, optics, PCBA, robotics, fluid handling)
Demonstrated ability to conduct systematic data-driven troubleshooting of complex bioinstrumentation; designing and executing controlled failure and stress experiments, developing and interpreting reliability metrics (e.g. run charts, reliability growth curves, performance dashboards)
Proven ability to translate field and manufacturing issues into design or process improvements
Experience authoring documentation for bioinstrumentation that meets design control and appropriate quality requirements
Comfortable working and communicating directly with customers, contract manufacturers, and suppliers
Ability to work in a fast-paced startup, with an interdisciplinary team
Highly independent, organized, and proactive with ability to prioritize across ambiguous problem spaces
Excellent written and verbal skills, with superb attention to detail
Willingness and ability to travel to support field installations and CDMO efforts, domestically and internationally.

Nice To Haves

Startup experience launching bioinstrumentation products into the field
Experience in diagnostics tools, research use only tools, medical devices, robotics, or similar regulated products
Familiarity with structured problem-solving tools (FMEA, root cause analysis)
Experience supporting early production ramp and first-customer installs
Experience working with eQMS systems

Responsibilities

Own the integration of CDMO-developed design into the company’s design history file and eQMS ensuring compliance with product development requirements while supporting reliability and manufacturability improvements.
Own design transfer with CDMO to production, including drawings, specifications, BOM
Own manufacturing and supplier feedback loops to drive robustness, yield, and field reliability
Drive design and manufacturing process changes that improve instrument robustness and manufacturability
Develop deep end-to-end understanding of product, workflow, and customer use cases to inform reliability strategy
Strong cross‑functional communication skills, including technical documentation and customer-facing communication.
Must be detailed orientated
Highly independent, organized, and proactive with ability to prioritize across ambiguous problem spaces
Own design transfer with CDMO to production, including drawings, specifications, BOM into the company's eQMS
Own reliability readiness for product launches and early field deployment
Identify reliability risks across hardware, software, manufacturing, installation, and usage
Lead root cause investigations for field and manufacturing issues at CDMO
Drive corrective actions in collaboration with design and development engineers
Review manufacturing processes for robustness and repeatability
Work directly with contract manufacturers to identify and resolve reliability and process issues
Support supplier investigations related to component or subassembly reliability
Recommend manufacturing process changes, inspection improvements, or supplier actions to prevent failures
Lead failure investigations, nonconformances, and corrective actions with technical rigor and communication cross functional teams
Develop and contribute to risk assessments and reliability-related documentation
Help define pragmatic reliability and quality processes suitable for a startup environment
Track and report reliability metrics such as field failures, early-life issues, and systemic risks
Provide structured feedback to design and development engineers based on field and manufacturing learnings
Recommend design changes to improve reliability, serviceability, and manufacturability
Participate in design reviews with a reliability and field-use perspective
Support change implementation and validation related to reliability improvements
Support field troubleshooting and early-life failure investigations
Actively participate in field installations to understand real-world use cases, environmental conditions, and customer workflows
Serve as the technical bridge between field experiences, engineering teams, and CDMO