Principal Project Engineer - Reagent Chemist

Company: Joule
Location: Brookline
Posted on: June 17, 2022

Job Description:

Title: Principal Project Engineer- Reagent Chemist
Location: Boston, MA
Schedule: Mon-Fri 8AM-5PM
Type: Direct Hire
Start date: ASAP
Responsibilities:3 main responsibilities for this role. Tech contributor to chemical reagent strategy; working closely with supply chain and where the materials are acquired from, Bridging new reagents into production; working closely with scientific group as they develop new reagents helping from scale to a manufacturing level, Developing out biologics materials; for the tank system will work with external vendors to bring it to commercial level
Working together with the operations and supply chain organizations, this role will have technical ownership of our overall reagent and chemical supply strategy. This will include assessment of vendors and the development and execution of qualification strategies
Contribute to the development of novel reagents and ensure they are ready for transfer to manufacturing processes
Lead the development of biologic control systems for use in in-vitro diagnostics
Provides technical support to manufacturing and quality organizations to aid in the troubleshooting of reagent based non-conformities and corrective actions
Demonstrates deep/advanced knowledge of specialized discipline and methods, and applicability to specialized product needs to support customer, operational policies and processes. Interfaces with customers, suppliers, application users, and other technical and support personnel as necessary
Develops complex test protocols; reviews, and rejects or approves test protocols developed by others, documents/reports findings, and provides corrective guidance

Requirements:BS in a relevant Engineering discipline such as Biomedical, Chemical, Mechanical or equivalent required
10 years hands-on technical experience developing complex / multidisciplinary reagent systems for in-vitro diagnostics required
10 years experience with medical device / IVD development under FDA Quality Systems Regulations, CE Marking, and ISO Quality Systems required
5 years experience with hemostasis based diagnostic and reagent systems preferred
3 years proven technical leadership over the development of a complex / multi-disciplinary product in a regulated environment required


Joule, a System One division is a leader in specialized workforce solutions and integrated services. With more than 6,000 employees and roughly 50 offices throughout the U.S. we provide scientific, clinical, engineering, energy, IT, legal and administrative staffing services. For more than 40 years, we have delivered workforce solutions and integrated services to clients nationally.

Keywords: Joule, Brookline , Principal Project Engineer - Reagent Chemist, Engineering , Brookline, Massachusetts