Design Assurance Engineer II

DiaSorin•Austin, TX

9d•Onsite

About The Position

The Design Assurance Engineer II 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 II 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 II may also provide support for quality initiatives, post market design changes/improvements and quality surveillance activities.

Requirements

Bachelor's Degree in a life science/engineering discipline required
5+ Years Experience in regulated environment required, 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
Excellent interpersonal, verbal and written communication skills
Strong computer skills (Microsoft Windows and Office programs), familiarity with Oracle preferred
High degree of problem solving and analytical skills
Ability to apply statistical tools
Strong organizational and time-management skills

Nice To Haves

1+ Years Working knowledge of current industry quality practices under QSRs, ISO-13485 and international regulations preferred
1+ Years Experience with medical device risk management (ISO 14971) is preferred
1+ Years Experience with usability (ISO 62366) is preferred
Certification in a quality discipline preferred, such as CQM, CQA, CQE, etc.

Responsibilities

Participates on design core teams utilizing experience to guide team members through the Design Control processes to achieve business, operational, quality, regulatory, and safety goals for new products.
Assists team members in the creation and maintenance of design deliverables (Design & Development Plans, Inputs/Outputs, Protocols, Matrices, etc) are ensures they 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
Develops and implements quality system improvements within the design processes.
Supports quality system training and participates in the development of training programs
Other duties as assigned.

Benefits

Diasorin is committed to building a workplace where people feel empowered to contribute ideas, take ownership, and grow their careers.
We believe diverse perspectives strengthen innovation and help us deliver meaningful impact for patients and customers worldwide.
Diasorin 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, protected veteran status, or any other characteristic protected by applicable law.
This posting and recruitment process are subject to applicable local laws and regulations in the country where the position is located. Additional employment disclosures, candidate rights, and employment conditions may apply based on local jurisdiction.
Individuals hired will be required to verify identity and eligibility to work and may be subject to a background check and drug screening where permitted by law.
Diasorin is committed to providing reasonable accommodations for qualified individuals with disabilities during the application process. If assistance is required, please contact [email protected].
Recruitment Fraud Notice
Diasorin never requests payment, financial information, or personal banking details from candidates at any stage of the recruitment process. Official communications from Diasorin recruiters will only come from a verified @diasorin.com email address. If you have questions about the legitimacy of a recruitment communication, please contact [email protected] for verification.
Unauthorized third-party recruiting agencies may not submit candidates for this position without prior written authorization from the Diasorin Human Resources Department.