Process Engineer

Austin, TX

Full Time

Mid Level

Process Engineer

About Paradromics
Paradromics is building an advanced brain computer interface (BCI) platform engineering neurotechnology solutions for unmet medical needs. A revolutionary leap beyond today’s research-grade BCI, our Connexus® BCI collects neural signals at an industry-leading, high-data rate and is designed for long-term therapeutic use. With the brain in direct communication with digital devices, we can leverage technology to transform how we treat conditions ranging from sensory and motor deficits to untreatable depression and pain management—allowing millions of people to live happier, healthier, and more enriching lives.

The Role
The Process Engineer will be responsible for implementing and improving processes for manufacturing the Paradromics BCI device and it’s subcomponents.

Responsibilities

Provides technical guidance and training for manufacturing personnel as needed
Designs, develops, implements, and maintains various manufacturing processes; Ensures that timelines, cost, and quality expectations are met
Evaluates failure analysis to find root cause and implements sound engineering solutions
Documents and execute process validations (IQ/OQ/PQ)
Work with contract manufacturers on outsourced process development and inspection.
Works with other organizations (R&D, Quality, Regulatory, Supply Chain) to complete product/process deliverables (including but not limited to: Procedures, Test methods, and Specifications)
Tracks process performance and quality standards. (scrap %, costs, lead time, and quality issues)

Required Education

B.S. degree in Manufacturing Engineering or similar field
Minimum 2+ years of engineering experience in the medical device industry or similar regulated industry

Required Qualifications

Skilled and knowledgeable in manufacturing and new product processing; should have effectively developed processing on multiple new development projects.
Project management skills suitable to lead small to medium scope development projects
Demonstrated experience and success in process development
Prior experience with process FMEAs and IQ/OQ/PQ of equipment toolsets
Prior experience utilizing statistical process control methodology
Innovative problem solver with ability to work independently and in a team environment
Demonstrates advanced problem-solving skills through the use of quality and statistical tools
Demonstrates exceptional written and verbal communication exhibiting a high-level technical expertise.
Be able to work with people at all levels of an organization

Preferred Qualifications

Working knowledge of applicable regulations such as FDA 21 CFR Part 820, ISO 13485, and ISO 14971.
Prior experience with front & backend semiconductor processes
Prior experience with dimensional inspections via manual or automated optical inspection. AOI tool experience, Laser Profilometer, Scanning Electron Microscope
Prior Failure Analysis Experience
CAD experience, Solidworks preferred
Knowledge geometric dimensioning and tolerancing

Paradromics is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, or national origin.

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Process Engineer

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