Bruker Daltonics ยท 15 hours ago
Product Development Engineer, Reagents
Emeryville, CA
Full-time
Onsite
Mid, Senior Level
$78K/yr - $140K/yr
5+ years expBruker Daltonics is a leading analytical instrumentation company dedicated to enabling scientists to make breakthrough discoveries. The Product Development Engineer for Reagents will support the company's growing reagent portfolio by qualifying testing methods and facilitating the transfer of products from R&D to manufacturing.
Biotechnology
Responsibilities
Work with technical teams to establish quality control methods and specifications for all raw material components, bulk reagents, and finished good products
In the spirit of continuous improvement, evaluate QC methods, quality controls, and production processes to ensure delivered products meets expected quality and performance standards
Creates and executes test and validation plans based on production specifications and requirements
Works cross functionally and partners closely with R&D in the product design process in addition to manufacturing to span technology transfer seamlessly between the functions
Define and iterate on business processes to stream
Stability test method development and characterization for existing and new products and their raw material components
Serve as technical liason for all reagent product quality excursion events, identify and clearly communicate causes and corrective action plans within the organization, and implement changes to prevent recurrence
Manage supplier material quality and drive resolution of quality issues with supplier through corrective and preventative actions
Review and revise manufacturing work instructions and procedures as needed to ensure product fitness for use
Provide support for synthesis and analysis of quality data
As needed for supporting surge demand or higher complexity products, support production execution of reagents
Support record keeping in the manufacturing execution system (MES), enterprise resource planning (ERP), and product lifecycle management (PLM) softwares
Qualification
Required
B.S. or M.S. in Chemistry, Chemical Engineering, Materials Science or equivalent with 5-8 years of hands-on experience developing quality test methods in an analytical or manufacturing setting for chemicals/reagents
Experience performing reagent QC using common analytical techniques: UV-Vis spectroscopy, pH measurements, binding affinity measurements, particle density, etc. This might also include running functional tests on BCA platforms as needed
Demonstrated problem solving leadership in a manufacturing setting. Ability to drive to the root causes of problems and implement robust solutions
Experience using and maintaining laboratory equipment (pipettes, biosafety cabinets, centrifuges, vortexers, etc.)
Strong attention to detail with good documentation skills. Demonstrated ability to write comprehensive procedures and reports
Data-driven, proficient with design of experiments (DOE), statistical analysis, statistical process control (SPC), applies structured problem solving to manufacturing issues, and owns the resolution of manufacturing problems
Adept troubleshooting skills, including the ability to isolate and resolve component level failures
High attention to detail
Well organized, self-motivated, and able to work independently
Strong interpersonal skills with ability to communicate and interface positively with other team members and departments
A passion for technology and a willingness to take ownership of results
Preferred
Relevant experience in the Life Science industry
Ability to multi-task and prioritize workload to meet deadlines
Strong aseptic techniques
Prior experience operating in a clean room environment
Understanding of Lean Manufacturing Principles and 5S standards
Experience with manufacturing change control processes
Preferred experience with GLP/cGMP and ISO quality standards
Preferred regulatory knowledge
Benefits
401(k) with company match
Employee stock purchase plan
Medical and dental plans
Life insurance
Short-term and long-term disability insurance
Employee assistance program
Paid time off including vacation, sick time and holidays
Company
Bruker Daltonics
Bruker Life Science Mass Spectrometry is a leading global developer and manufacturer of innovative scientific instruments that address the rapidly evolving needs of a diverse array of life sciences customers.
Founded in 1960Billerica, Massachusetts, US
1001-5000 employees
H1B Sponsorship
Bruker Daltonics has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
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Trends of Total Sponsorships
2025 (1)
2023 (1)
2022 (2)
Funding
Current Stage
Late StageCompany data provided by crunchbase