- Working collaboratively with the Operations and Supply Chain teams, having ownership of overall reagent and chemical supply strategy. This will include the assessment of vendors and the development and execution of strategies for qualification.
- Providing support to Manufacturing and Quality organizations to aid in the troubleshooting of the reagent-based discrepancies.
- Demonstrates advanced knowledge of specialized discipline and methods, and applicability to specialized product needs to support the customer, operational policies, and processes. Interface with customers, suppliers, application users, and other technical and support personnel as necessary.
- Communicate risks and include all mitigations in project planning activities.
- Maintain personal functional expertise through networking, conferences, associations, training, and literature review.
Lead the development of biologic control systems for use in IVD.
Contribute to the development of novel reagents and ensure they are ready for transfer to manufacturing processes.
Facilitate and resolve problem solving and decision-making activities.
Analyze experimental data, develop technical conclusions, and evaluate importance of recommendations.
Develops complex test protocols; reviews, and rejects or approves test protocols developed by others, documents/reports findings, and providing corrective guidance.
Coordinate work primarily across project team(s), related groups, or within the department. Communicate proactively and effectively at all levels.
- Bachelor's degree in a relevant Engineering discipline such as Biomedical, Chemical, Mechanical, or equivalent is required
- Master's degree in a relevant Engineering discipline is preferred
- 5 years of experience with hemostasis-based diagnostics and reagent systems is highly preferred.
- 3 years of Technical Lead experience over the development of a comprehensive product in a regulated environment is required.
- Systems thinking-mindset including a broader perspective for the system, including the product, its lifecycle, use environment, stakeholders, and beneficiaries, etc.
- Strong knowledge of modern product development and project engineering principles, methods, and practices.
- Design for Six Sigma experience is preferred.
Systems Engineering experience is preferred
10 years of hands-on technical experience developing systems for IVD under FDA Quality Systems Regulations, CE Marking, and ISO Quality Systems is required.
- 100% remote, Eastern Time Zone preferred
- Health insurance
- 401k match
Casual Dress code