Adarza BioSystems, Inc. is recruiting a Senior Systems Product Manager to help with all phases of Adarza’s instrumentation systems development from ideation and design through DFM, commercial release and customer support. The Sr. Systems Product Manager will lead Adarza’s internal engineering group as well as manage our external design engineering vendor to develop Adarza’s next-generation product system including the core instrumentation (optical imaging and fluidics based assay processing subsystems), software including instrument control and data analysis. This person will also be responsible for design, development, and improvement of instrumentation & software utilized internally at Adarza for R&D and manufacturing. Further, the ideal candidate will have experience implementing appropriate documentation processes as well as a network of experienced engineers to recruit to the team as needed. The candidate will have obtained either a BS or BS/MS or PhD in one of the Engineering disciplines (e.g. Mechanical, Electrical, Systems). Candidates must l have a minimum of 10 years’ experience and a successful track record in laboratory instrument product management from design and stage gate development through product launch of laboratory instruments of similar complexity to Adarza’s with a leading laboratory instrument manufacturer.
Responsibilities: The qualified individual will independently, with general guidance from design firm and operations management, execute the installation, support and upgrade of a new immunoassay laboratory instrument. Specific responsibilities are detailed as follows.
- Lead the design, fabrication, and maintenance of Adarza’s current and planned off the shelf and custom instrumentation systems for commercial use as well as internal manufacturing.
- Develop appropriate documentation and strategy for entire instrument and software lifecycle including post-consumer support, maintenance and updates.
- Intimate knowledge of 510(k), 21 CFR part 11, and other regulatory certification processes.
- Project management and hands-on design work, verification and validation, with the design firm to create an instrument integrating preparation and analysis of Adarza’s AIR substrate using input from Operations and R&D to insure the final product meets operational requirements, including calibration methodologies.
- Lead team to develop PRD, V&V, DHS files, and other documentation as necessary.
- Lead team to develop and implement appropriate testing methods to allow demonstration of the validation requirements.
- Working with the Director of Manufacturing, oversee the installation and validation of instrumentation in Adarza’s manufacturing facilities.
- Oversee junior engineers who support/maintain internal systems.
- Create and complete installation and user documentation for eventual customer use.
- Prepare, document and present at regular intervals, progress summaries to operations management.
Position Requirements: The ideal candidate will have a demonstrated track record of excellence working with the laboratory instrument design, including image processing toolboxes and development frameworks. Specific position requirements are listed below.
- BS, MS, or PhD degree in an Engineering discipline (e.g. Mechanical, Electrical or Systems) with 10+ years of experience in complex laboratory instrument development.
- Familiarity with the following programing programming languages:
- C/C++ (desirable library exposures include the OpenCV, QT and Boost libraries)
- M-Code (MatLab)
- Labview (National Instruments)
- VisualBasic or related languages
- Experience with FTDI chipsets and related camera interfaces is beneficial but not essential.
- Experience with Java, Microsoft .NET or SQL is beneficial but not essential.
- Attention to detail combined with strong prioritizing and multi-tasking skills to work within deadlines.
- Proven ability to effectively collaborate with others, initiate actions, adapt to change, and accept challenging assignments.
- Experience with GMP guidelines, FDA and AOAC regulations, medical device design control, and manufacturing scale-up processes a plus.
- Ability to work in the United States.
Job: Salaried full time.
Primary Location: O’Fallon, MO (greater St. Louis area) with responsibility for engineers in Adarza’s Rochester, NY R&D facility. Extensive travel (up to 100%) may be required for periods of time for specific early development projects.