- Late-stage product development and prototyping for both consumables and reagents formulations
- Working with product development scientists to build standardized processes for consumable assembly and testing
- Supporting Product Development teams by assembling small scale to pilot batches of reagents and consumables;
- Developing component specific QC methods and build process control management strategies;
- Building process maps and drive critical parameter management (CPM) activities
- Designing and executing DOEs
- Analyzing built and purchased lot QC data to evaluate material quality and process control requirements
- Supporting material management and logistics activities
- Experience with early NPI Process Development
- Proficieny in assembly of plastics and glass assemblies and prototyping processes;
- Proficieny in reagent formulations, fill and finish processes
- Proficieny in implementing traceability, documentation, workflows and work instructions
- Wet bench skills and have working knowledge of DNA, PCR, and NGS
- Experience in Lean Six Sigma and SPC implementation
- Experience with cGMP and ISO13485 Manufacturing Environments
- Knowledge of R, JMP and/or Python for statistical data analysis and manipulation
- Have previously worked on development and prototyping of a fluidic consumable used in a medical device or diagnostic instrument
- Have previously worked on quality control and process control management for consumable assembly
- Master's Degree or higher in Bioengineering, Biomedical Engineering, Mechanical Engineering or related
- 5+ years of experience
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Director of Process Engineering - California, United States - Pleno Inc.
2 weeks ago
Description
We are seeking a Head of Process Engineering – Process Development, Reagents and Consumables to join our team onsite in our lab in San Diego. Come join us to work on the development and testing of our flagship multi-omic instrument platform. This position requires excellent process development skills demonstrated by many years of experience and a track record of successful product transfer. In this role you will be acting as the interface between development and pilot/manufacturing. You will design, implement and scale processes for reagent formulations, consumable assemblies, fill and finish and lot traceability. You will closely collaborate with our reagent and assay development groups as well as system integration to define and document process maps, workflows, work instructions and QC methods, design and execute DOE, participate or lead Critical Parameter Management activities as well as lead troubleshooting and sustaining activities.
In this role, you will be responsible for:
To be successful in this role you have:
You will be a leading applicant if you have experience with:
Required Qualifications:
Note: This position will require regular onsite participation at our office/lab in San Diego, CA - to apply you should be resident in the greater San Diego county area or in the process of relocating.
The compensation range presented spans Senior Staff to Principal. Compensation decisions are dependent on several factors including, but not limited to, level of the position, skills, knowledge and experience, internal equity, and alignment with comparable market data.
About Pleno
Pleno is a multidisciplinary team of scientists and technologists focused on collaboration and asking questions. We strive to find the best, and most meaningful answers for biochemistry and engineering problems in our mission to build a revolutionary instrument platform.
We are developing multi-omic instrument platforms that will revolutionize biological target detection for a wide array of meaningful applications. Come join us to be a part of the biomedical revolution?
All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, national origin, or on the basis of disability, gender identity, and sexual orientation. In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification form.
