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Diasorin · 2 days ago
Senior Design Assurance Engineer
Austin, TX
Full-time
Onsite
Senior Level
8+ years exp
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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.
Qualification
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Required
Bachelor's Degree in a life science/engineering discipline required
Minimum 8 years' experience in a regulated environment required, with previous design assurance experience required
Experience in an Good Manufacturing Practices (GMP) environment required, preferably in medical device industry required
Experience as a member of a design team required
Preferred
Working knowledge of current industry quality practices, such as QSRs, ISO-13485 and international regulations preferred
Experience with medical device risk management (ISO 14971) preferred
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
Benefits
Competitive salary and benefits package
Company
Diasorin
DiaSorin is an Italian multinational Group and a global leader in the market for in vitro diagnostics
1,001-5,000 employees
H1B Sponsorship
Diasorin has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Trends of Total Sponsorships
2022 (1)
Funding
Current Stage
Late StageLeadership Team
Doug Schuenke
CFO and VP Finance
Davide Marietta
Corporate CIO
Company data provided by crunchbase
