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Sr Design Assurance Engineer - US

Company: Luminex
Location: Austin
Posted on: July 13, 2018

Job Description:


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.--

ESSENTIAL JOB DUTIES:

-----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.

--

JOB REQUIREMENTS:--

Required Education/Training:

--- Bachelor degree required, in a life science/engineering discipline required

Required Certifications/License/Special Skills:--

-----Excellent interpersonal, verbal and written communication skills

-----Certification in a quality discipline preferred, such as CQM, CQA, CQE, etc.

-----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

-----Demonstrated ability to lead successful teams--

Required Work Experience:

-----Experience in an Good Manufacturing Practices (GMP) environment required, preferably in medical device industry



  • Working knowledge of current industry quality practices, such as QSRs, ISO-13485 and international regulations

    --- Experience as a member of a design team required

    --- Minimum 8 years experience in regulated environment required, with previous design assurance experience preferred

    -----Experience with medical device risk management (ISO 14971) is preferred

    -----Experience with usability (ISO 62366) is preferred

    WORKING CONDITIONS:----

    -----Must work onsite at Luminex office at least 90% of the time

    -----Travel may be required approximately: 20% of the time

    -----International travel may be required

    -----Possible exposure to biological or chemical hazard, extensive noise, and/or working with lasers

    -----Work situations include dealing with people; working alone; making judgments and decisions; and directing, controlling or planning the activity of others
  • --Lifting/Use of Strength is Sedentary (up to 10 pounds)

    Keywords: Luminex, Austin, Sr Design Assurance Engineer - US, Engineering, Austin, Texas

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