• 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 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.Design Assurance Engineer is responsible for guiding the development teams through the Design Control process ensuring compliance with FDA, ISO, QSR, quality, safety and environmental regulations and internal procedures. The Design Assurance Engineer may also provide support for quality initiatives, post market design changes/improvements and quality surveillance activities.

Key Responsibilities and Duties

• Participates on design core teams utilizing experience to guide team members through the Design Control processes to achieve business, operational, quality and safety goals for new products.
• 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.
• Guides 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.
• Acts as a resource within and cross departmental for design control related questions & challenges
• Coaches departmental personnel in the engineer's area of responsibility.
• Supports quality system training and participates in the development of training programs
• Acts as escort and/or supports during external audits/inspections
• Other duties as assigned.

Education, Experience, and Qualifications

• Bachelor's Degree required, in a life science/engineering discipline required
• 1 Years Experience in an Good Manufacturing Practices (GMP) environment required, preferably in medical device industry
• 1 Years Working knowledge of current industry quality practices under QSRs, ISO-13485 and international regulations
• 1 Years experience as a member of a design team preferred
• 5 Years experience in regulated environment required, previous design assurance experience preferred
• 1 Years Experience with medical device risk management (ISO 14971) is preferred
• 1 Years Experience with usability (ISO 62366) is preferred

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.