Staff Test Engineering Lead
Role details
Job location
Tech stack
Job description
We are seeking a staff, hands-on engineering leader to define and own production test strategy for complex, connected medical devices spanning PCBAs through final high-level assemblies (HLAs). This individual will play a critical role in ensuring robust, scalable, and compliant manufacturing test frameworks across overseas contract manufacturers (CMs). This role will partner closely with Systems, Design, Firmware, Quality, and Manufacturing. While test execution and IQ/OQ/PQ validation are performed by the CM, this role is accountable for architecting the test approach, defining requirements, and ensuring technical adequacy of CM-implemented solutions. When manufacturing issues exceed CM troubleshooting capability, this person will act as a deep technical escalation point, leveraging detailed product knowledge to guide root cause analysis and corrective actions., Production Test Strategy & Architecture
- Define the end-to-end production test strategy for medical devices, including Bare PCBAs, Sub-assemblies and Final HLAs (system-level functional, calibration, connectivity, and safety tests)
- Author clear test requirements and specifications for CM implementation.
- Establish test coverage aligned with risk (ISO 14971), design intent, and regulatory requirements.
- Drive decisions on test partitioning (what is tested where, at which stage, and why).
- Balance test coverage, cost, cycle time, and scalability for high-volume manufacturing.
Test Frameworks
- Define standardized test architectures and frameworks, including:
- Test hardware concepts (fixtures, probes, golden units, loopback schemes)
- Test software architecture (Python, LabVIEW, custom frameworks, automation)
- Data capture, traceability, and serialization strategies
- Ensure test designs & strategies support regulatory compliance, Field reliability, Post-market investigations and CAPAs.
Contract Manufacturer Technical Leadership
- Serve as the technical authority for production test across overseas CMs.
- Review and approve CM-developed test concepts, fixture designs and test software approaches
- Provide strong technical guidance while allowing the CM to own execution and validation.
- Participate in DFM/DFT reviews and NPI readiness assessments.
- Support audits by clearly articulating test intent, coverage rationale, and CM responsibilities.
Escalation & Deep Technical Triage
- Act as an escalation point and deep div into root cause analysis when Yield issues persist and / or CM engineering teams are unable to resolve complex failures.
- Partner with Sustaining Engineering, Quality, and Systems teams to drive corrective actions.
- Ensure lessons learned feed back into improved test coverage and future designs.
Requirements
Do you have experience in Scalability?, Do you have a Master's degree?, * BS/MS in Electrical Engineering, Computer Engineering, or related field.
- 10-12+ years of experience in Hardware test engineering, Manufacturing test or NPI for very high volume consumer or regulated products (medical, aerospace, automotive)
- Strong understanding of Mixed-signal PCBAs, Embedded systems (MCUs, SoCs, sensors, power management), System-level test challenges (connectivity, calibration, analog performance)
- Proven experience defining production test strategies rather than just executing tests.
- Deep knowledge of ICT, functional test, boundary scan, calibration, and parametric testing.
- Familiarity with Python-based test frameworks, LabVIEW, and test data analytics.
- Prior experience working directly with overseas CMs in Asia/ Mexico.
Soft Skills & Leadership
- Able to operate effectively across time zones and cultures.
- Comfortable acting as a technical authority without direct line management of CM teams.
- Pragmatic, risk-based decision maker with a systems-level mindset.
Nice to Have:
- Familiarity with FDA-regulated manufacturing environments (21 CFR 820).
- Experience supporting post-market investigations and CAPA from a test perspective.
