Job ScopeThe 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.
Job Responsibilities and Duties- 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.
Education, Experience and Qualifications- 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
- 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
- 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
Standard Working Conditions- Must work onsite at Luminex office - Occasionally
- Possible exposure to Chemicals, Lasers, Excessive Noise, etc. - Frequently
Travel Requirements- 20% Travel may be required; internationally
