Hybrid in Atlanta, GA (remote work is ok, we just need someone to come in as needed)

Job Title:

Sr Manufacturing & Sustaining Engineer

•$160

•180k (Med Device)

Salary:

$160k

•180k base + equity, unlimited PTO, benefits

Requirements:

Medical device, ideally electrical engineering and PythonWe are an FDA approved rapid growth medical device org.

We created a wearable device which diagnoses sleep apnea and arrhythmia.

This technology has huge potential for other applications, and we plan to apply it to heart failure and diastolic functions next.

This device is a cutting-edge practical alternative to the standard, clunkier, alternative.

This is our second successful start up. Our founding team previously took an orthopedics start ups from conception through exit.

We have 70team members and are funded for around $14MM, just closed an additional round of funding a few months ago, and have a few years or runway.

Due to growth we're looking for a Sr Manufacturing & Sustaining Engineer with the following experience:

Medical deviceMechanical engineeringManaging timelines and design transfersBrining a new design to market

Job Duties:

Manufacturing Transfer & New Product IntroductionLead manufacturing handoffs and design transfer from development through pilot builds, production release, and scale-up including external and internal project management.

Coordinate NPI activities with contract manufacturers and suppliers; establish manufacturing readiness criteria, deliverables, and action plans.

Support DFM/DFA, tooling and fixture development, first article inspections, process characterization, and production readiness reviews.

Partner with Quality on appropriate process validation and qualification activities, including

IQ/OQ/PQ

where applicable.

Sustaining EngineeringOwn mechanical sustaining engineering activities for SANSA throughout the commercial product lifecycle.

Create and maintain manufacturing documentation, including BOMs, engineering drawings, assembly instructions, specifications, and inspection criteria.

Support component obsolescence, alternate part qualification, cost reductions, reliability testing, and engineering change control.

Collaborate with electrical, firmware, systems, manufacturing, and quality engineering to maintain device safety, performance, and manufacturability.