Biolinq (San Diego, CA) is seeking to hire a full-time Senior Process Engineer to assist in its product development efforts. A competitive compensation package (salary + equity) is offered in conjunction with the opportunity to define product specifications and shape the direction of Biolinq’s biosensor devices. You will have the unique opportunity to work in an exciting startup environment and contribute to the course of product development, design, and implementation.
DESCRIPTION
This is a dynamic role as part of a team of engineers and scientists developing a novel intradermal biosensor technology. It is a highly influential role straddling R&D, product development, and manufacturing using extensive knowledge of statistical methods, process control & optimization, and design controls. You will have the opportunity to define the direction of the company’s first product, from R&D, to clinical trials, to the regulatory submission process. You will demonstrate your sound process development and analytical skills by optimizing the biosensor synthesis process in the R&D setting and translating this process to pilot and volume manufacturing while ensuring maximum uniformity and minimal process variation. This entails establishing performance criteria and corroborating results in a statistically significant manner.
WHAT YOU’LL BE RESPONSIBLE FOR
- Optimizing R&D biosensor synthesis processes for maximal throughput and minimal unit-to-unit variation
- Translating biosensor synthesis processes to pilot and volume manufacturing while minimizing process variation
- Implementing process control measures and defining protocols required to conform to established quality standards
- Developing specifications & test methods to experimentally validate process design in a statistically significant manner
- Working with semiconductor manufacturing partners to synthesize next generation biosensor architectures
- Implementing various statistical methods aimed at understanding and quantifying process variability
- Statistical analysis of system performance under relevant operating environment(s)
- Defining specifications, generating documentation, and establishing traceability measures based on regulatory requirements established by FDA, ISO, and various notified bodies.
EDUCATION, EXPERIENCE, AND KEY SKILLS
- BS Degree or higher in Chemical Engineering or equivalent field
- َAbout 5+ years experience in a regulated medical product or diagnostic development environment (i.e. 510(k), PMA)
- Solid experience with process control, development, & optimization, design controls (21 CFR 820.30), ISO specifications (13485), and related documentation protocols for medical devices, including design history files
- Expertise in process engineering as it pertains to semiconductor and MEMS manufacture
- Strong foundation in statistical analysis, including measures of confidence, identifying appropriate sample size and error, determining distributions and performing tests of significance, assessing coefficients of variation, among others
- Familiarity with statistical / mathematical modeling tools (i.e. Excel, Matlab, Minitab, Mathematica, Origin, R)
- Ability to interface across scientific and engineering teams and work in a fast-paced, multi-disciplinary environment
- Ability to manage multiple projects and communicate ideas clearly to the team; highly methodical and detail-oriented
- Willingness to take the lead on the implementation of process control systems in the R&D and manufacturing environments and familiarizing all employees with requirements and protocols therein
WHO WE ARE
Biolinq is a startup that has developed a proprietary wearable biosensor platform that is capable of measuring blood level information, without the need to draw blood. We are developing products that are changing the way patients and consumers access information about their body, by making new levels of actionable information readily available. We are dedicated to the personal and professional growth of all our team members and strive to create a positive and creative work environment.
