Senior Process Development Engineer
Laxmi Therapeutic Devices – Pasadena, CA
Job Description:
Laxmi started in 2016 with an idea and a mission to improve individual care with improved Continuous Glucose Monitoring Technology. Laxmi Therapeutic Devices is applying cutting edge advances in sensing, microfabrication and electronics to create the next generation of wearable diagnostic devices. We are connecting and empowering consumers, healthcare professionals and treatment providers with personalized medicine. Our versatile biosensor platform enables rapid, inexpensive, and dependable screening of important analytes, with a focus on glucose sensing for our first product.
A Senior Process Development Engineer is an experienced individual contributor that can work independently under limited supervision to make critical contributions to the development of our core technologies. They are responsible for understanding our technology goals, implementing and developing new processes, and the characterization and validation of processes and test methods. The Senior Process Development Engineer also mentors and reviews the work of lower-level contributors and may be responsible for entire projects or workstreams/processes. They make decisions for processes, systems, and products based on statistically relevant data to improve overall product performance and manufacturing efficacy.
Primary Responsibilities:
Provides technical and sustaining engineering leadership in a manufacturing area.
Develop, implement, and refine metal plating, deposition, and coating processes for reproducibility and scale up of biosensors.
Recommends and implements equipment and process modifications to meet quality standards and improve production efficiencies, manufacturing techniques, as well as production yields for existing products.
Analyzes equipment and material capabilities to meet process target specifications and design target specifications. Proposes changes based on findings.
Reviews product development requirements for compatibility with processing methods to determine manufacturing capabilities.
Interacts with product design and development personnel to ensure that processes and designs are compatible.
May develop and conduct statistical analysis or recommend additions to current processes and/or workflows.
Leads the innovation, development and/or optimization of new manufacturing concepts, processes and procedures for manufacturing operations. This can include researching and feasibility work, material selection, process and equipment selection, tooling/fixture and equipment installation, and assessment of inputs, outputs and alignment to requirements.
Develops manufacturing processes and utilizes applicable statistical process control. Utilizes statistical evaluation techniques for measurement systems e.g., Gage R&R analysis, ANOVA
Ensures processes and procedures follow regulations.
Optimizes manufacturing processes in support of transitioning to automation.
Perform process development/process validation in support of manufacturing readiness and maturity.
Leverages a multi-disciplinary approach to solve problems – Physics, Chemistry, Thermodynamics, Electronics
Apply First Principles thinking to complete robust process characterization and process development.
Create and complete validation documentation and route engineering change orders.
Quickly learn and collaborate on product design to help inform manufacturing changes.
Make use of appropriate technical skills and tools, such as DOE, SPC, hypothesis testing, capability studies, Gemba walks, and “hands on” analysis, to perform in depth analysis, determine root cause, and identify corrective actions.
Generate actionable ideas to reduce cost, reduce cycle time and increase yield.
Minimum Qualifications:
Education and Experience:
Bachelor’s degree required in an Engineering Discipline
Minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience
Flexibility to work in a rapidly developing environment.
Strong written and oral communication skills.
Ability to safely handle chemicals, wear personal protective equipment (PPE) correctly, and work in a clean room.
Ability to lift 25lbs.
Ability to stand for up to 8 hours in a single day while running experiments.
Preferred Qualifications:
3+ years of experience directly developing medical devices.
Demonstrated ability to manage multiple goals and priorities.
Prior start-up experience with the ability to quickly adapt to a fast-paced and fast-changing environment.
Travel: Up to 10% travel may be required
Job Type: Full-time
Salary Range: $100,000 - $125,000 annually, depending on experience
Job offer is contingent on positive completion of a background check.
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