The Position: Real Staffing Group is combing the Life Science Market for an experienced Principle Project Engineer to support a team focused on ensuring that their in-vitro diagnostic system meets project goals. This candidate will be responsible for developing, optimizing, and validating reagents for an in-vitro diagnostic system. The primary responsibility for this role will be the development of a strategy to ensure reagent and chemical sourcing.
The Company: Real Staffing Group is a leader in the provision of pharmaceutical, biotechnology, healthcare, and medical devices recruitment services. With one of the largest networks of specialist recruiters in the world, we partner with companies and organizations to help manage change and deliver cost and efficiency improvements through technology, information, and people. Our premise is a simple one: by recognizing talent and valuing relationships, we can consistently deliver local, global and industry expertise to ensure success.
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.
Lead the development of biologic control systems for use in IVD.
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.
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.
Communicate risks and include all mitigations in project planning 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.
Maintain personal functional expertise through networking, conferences, associations, training, and literature review.
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
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.
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.
100% remote, Eastern Time Zone preferred
Casual Dress code
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EOE Statement: Specialist Staffing Group is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.