Staff 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 Staff Process Development Engineer is an experienced individual contributor that can work independently and supervises teams 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 leading the characterization and validation of processes and test methods. Will be responsible for entire projects or workstreams/processes. Makes decisions for processes, systems, and products based on statistically relevant data to improve overall product performance, manufacturing efficacy, and reducing variability.

Primary Responsibilities:

  • Provides technical and sustaining engineering leadership in the manufacturing area as an SME.

  • Set the example of high performance for the team and help support the culture of achieving results and continuous improvement.

  • Defines requirements and identifies multiple equipment and process modifications to meet quality standards and improve production efficiencies and production yields.

  • Continually improves manufacturing techniques to reduce variability and improve yields and teaches other team members new skills and techniques in this area.

  • Reviews product requirements with processing methods and determines manufacturing processes meet specification through verification and validation.

  • Regularly utilizes statistical analysis of data from current processes and workflows to support development.

  • Both guides and directly supports the development and/or optimization of new manufacturing concepts, processes and procedures to support product development and root cause problem solving.

  • Leads the effort to develop supporting documentation such as pFMEA, risk registers, and other QMS documents.

  • This can include scouting 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 that are applicable to statistical process control and may develop those statistical techniques including the measurement systems.

  • Ensures processes and procedures are following regulations.

  • Perform process development and process validation in support of scaled-up manufacturing readiness and product maturity.

  • Leverages a multi-disciplinary approach to solve problems e.g., Engineering, Physics, Chemistry, Thermodynamics, Electronics

  • Apply First Principles thinking to complete robust process characterization and process development as well as problem solving. Teach this methodology to other team members and raise their skill level.

  • Create and complete validation documentation and route engineering change orders.

  • Collaborate on product design to help inform manufacturing changes. Champion the voice-of-manufacturing.

  • Regularly employ 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 8-9 years of relevant industry 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:

  • 9+ years of experience directly developing medical devices

  • Experience in Process Validation, MSA, IQ/OQ/PQ, Gage R&R, SPC, and general statistical analysis

  • Experience and understanding of good manufacturing practices, lean manufacturing, and DFM

  • Experience with thin film and wafer manufacturing

  • Advanced degree (e.g., Master’s) in a related field

  • Demonstrated ability to manage multiple goals and priorities

  • Demonstrated ability to technically lead project teams and engineering teams

  • Prior start-up

Travel: Up to 10% travel may be required

Job Type: Full-time

Salary Range: $115,000 - $145,000 annually, depending on experience

Job offer is contingent on positive completion of a background check.

Apply Now!

If you're interested in one of our open positions, start by uploading your resume and applying below.