24 Sep
Principal Project Engineer - Reagent Chemist at Boston, MA
Massachusetts, Boston , 02108 Boston USA

Vacancy expired!

Title: Principal Project Engineer - Reagent Chemist

Location: Boston, MA

Duration: Full Time

JOB SUMMARYThis is a Technical leadership role in a multidisciplinary development project team, responsible for ensuring that the in vitro diagnostic system, under development, meets its intended goals. The person in this role is capable of developing, optimizing and validating reagents for an in-vitro diagnostic system. This role will have primary technical responsibility for developing a strategy to ensure robust and cost effective reagent and chemical sourcing. ESSENTIAL DUTIESDuties are listed in order of greatest importance. The incumbent may be asked to perform other function-related activities in addition to the below mentioned responsibilities as reasonably required by business needs.Enter Responsibilities/Essential Duties
  • 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.
  • Facilitates and resolves technical group problem solving and decision making activities.
  • Communicates risks and include their mitigations in the project planning activities.
  • Analyzes experimental data, develops technical conclusions, and evaluates potential applicability of recommendations.
  • Coordinates work primarily across project team(s), related groups, or within the department. Communicates proactively and effectively at all levels. Expands understanding and employs sensitivity in communications with culturally diverse audiences.
  • 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.
  • Maintain personal functional expertise through networking, conferences, associations, training and literature review.
QUALIFICATIONS
  • BS in a relevant Engineering discipline such as Biomedical, Chemical, Mechanical or equivalent required
  • MS in a relevant Engineering discipline preferred
  • 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
  • A continuous improvement mindset and behavior is essential.
  • Systems thinking-mindset including a broader perspective for the system as a whole, including the product, its lifecycle, use environment, stakeholders and beneficiaries, among others.
  • Knowledge of modern product development and project engineering principles, methods and practices.
  • Systems Engineering experience preferred
  • Design for Six Sigma experience preferred
  • Ability to travel occasional 10%

Vacancy expired!


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