Join to apply for the Process Engineer role at Paradromics
Join to apply for the Process Engineer role at Paradromics
Process Engineer
Paradromics is building anadvancedbrain computer interface (BCI) platform engineering neurotechnology solutions for unmet medical needs. A revolutionary leap beyond today’s research-grade BCI, our ConnexusBCI 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 Process Engineer will be responsible for implementing and improving processes for manufacturing the Paradromics BCI device and it’s subcomponents.
- 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)
Process Engineer
About Paradromics
Paradromics is building anadvancedbrain computer interface (BCI) platform engineering neurotechnology solutions for unmet medical needs. A revolutionary leap beyond today’s research-grade BCI, our ConnexusBCI 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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