• Impactful Work: When you join Diasorin, you become part of a team that's dedicated to improving lives. Your contributions will directly impact patient care, making a meaningful difference in the world.

• Global Reach & Innovation: Our work transcends borders. Joining Diasorin means collaborating with colleagues from all over the world, expanding your horizons, and contributing to global healthcare solutions at the forefront of the diagnostic industry.

Job Scope

The Sr Design Assurance Engineer acts as the quality representative on design core teams for electromechanical instruments, reagents and assays for the life science and in-vitro diagnostics market. Sr Design Assurance Engineer is responsible for leading, coaching and guiding the development teams through the Design Control process ensuring compliance with FDA, ISO, QSR, quality, safety and environmental regulations and internal procedures. The Sr Design Assurance Engineer will provide support for quality initiatives, post market design changes/improvements and quality surveillance activities. The position is a subject matter expert for the department.

Key Duties and Responsibilities

• Participates on design core teams utilizing experience to guide and coach team members through the Design Control processes to achieve business, operational, quality and safety goals for new products.
• Leads or assists team members in the creation and maintenance design deliverables (Design & Development Plans, Inputs/Outputs, Protocols, Matrices, etc) are completed on-time and per regulations.
• Facilitates the risk management process for design teams through the creation of risk documents ensuring all risks are appropriately identified, mitigated and verified.
• Recommends rationale, including statistical tools, for protocol structure.
• Develops and implements quality system improvements within the design processes.
• Acts as a global expert for design control related questions & challenges.
• Mentors personnel to continuously enhance the company's quality culture and improve design processes.
• Leads quality system training and participates in the development of training programs.
• Leads internal compliance audits to applicable regulations and standards.
• Acts as escort and/or supports during external audits/inspections.
• Leads, and assures successful implementation, special projects as directed.
• Other duties as assigned.

Education, Experience and Qualifications

• Bachelor's Degree Bachelor degree required, in a life science/engineering discipline required required
• 8+ Years Minimum 8 years' experience in regulated environment required, with previous design assurance experience required
• 1+ Years Experience in an Good Manufacturing Practices (GMP) environment required, preferably in medical device industry required
• 1+ Years Experience as a member of a design team required
• 1+ Years Working knowledge of current industry quality practices, such as QSRs, ISO-13485 and international regulations preferred
• 1+ Years Experience with medical device risk management (ISO 14971) preferred
• 1+ Years Experience with usability (ISO 62366) preferred
• Must work onsite at Luminex office at least 90% of the time - Constantly
• Possible exposure to biological or chemical hazard, extensive noise, and/or working with lasers - Occasionally
• Work situations include dealing with people; working alone; making judgments and decisions; and directing, controlling or planning the activity of others - Frequently

Travel Requirements

• 20% Travel may be required, including international.

What we offer

Receive a competitive salary and benefits package as you grow your career at DiaSorin. Join our team and discover how your work can impact the lives of people all over the world.