Principal System Integration Engineer - Transfusion

About the Role

We are seeking a highly skilled and motivated professional to join our team. This role offers the opportunity to contribute to our mission of improving hospital efficiency and patient care through specialized diagnostic solutions. As part of our growing, family-owned organization, you will collaborate with global teams across our headquarters and technology centers in the US and Europe.

Responsibilities

• Lead and execute projects related to the development of customized assays and biomaterials within our OEM business line.
• Collaborate with cross-functional teams across Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplant areas.
• Drive innovation and quality in diagnostic solutions, ensuring alignment with customer needs and regulatory standards.
• Analyze and interpret complex data to support product development and improvement initiatives.
• Provide technical expertise and support to internal stakeholders and external partners in more than 100 territories.
• Contribute to continuous improvement processes and maintain high standards of operational efficiency.

Requirements

• Bachelor's degree in life sciences, biomedical engineering, chemistry, or a related field (advanced degree preferred).
• Significant experience in diagnostics, medical devices, or pharmaceutical R&D, with a focus on assay development or biomaterials.
• Proven track record of managing complex projects from concept to commercialization.
• Strong knowledge of regulatory requirements for in vitro diagnostics (IVD) or similar medical products.
• Excellent problem-solving skills and ability to work in a fast-paced, multi-disciplinary environment.
• Effective communication and collaboration skills, with experience working in international or matrixed teams.

Qualifications

• Advanced expertise in one or more of our core diagnostic areas: Hemostasis, Acute Care Diagnostics, Transfusion, or Autoimmunity.
• Experience with OEM partnerships or custom manufacturing processes.
• Familiarity with quality management systems (e.g., ISO 13485, FDA QSR).
• Proficiency in data analysis tools and statistical software.
• Ability to travel internationally as needed to support global projects and partnerships.

Skills

• Strong technical writing and documentation skills for regulatory submissions and technical reports.
• Project management and organizational skills, with attention to detail and deadlines.
• Leadership and mentoring abilities to guide junior team members.
• Adaptability and willingness to learn new technologies and methodologies.
• Fluent in English; additional languages (Spanish, French, German) are a plus.