Design Assurance Engineer - US

The Quality Assurance team is seeking candidates for an available Design Assurance Engineer position within the team. The selected candidate would be responsible for the following:

·       Acting as the quality representative on design core teams for electromechanical instruments, reagents and assays for the life science and in-vitro diagnostics market

·       Guiding the development teams through the Design Control process ensuring compliance with FDA, ISO, QSR, quality, safety and environmental regulations and internal procedures 

·       Providing provide support for quality initiatives, post market design changes/improvements and quality surveillance activities 

Key Responsibilities & Duties:

·       Conflict Management—settles disagreement and disputes equitably

·       Learning on the Fly—learns quickly/open to change

·       Organizational Agility—knows how to go through the proper channels to get things done

·       Peer Relationship—cooperative, team player, trusted and supported by peers

·       Problem Solving— identifies complex problems and reviews related information to develop and evaluate options and implement solutions

·       Timely Decision Making—decisions can be made quickly even under tight deadlines and pressure

·       Written Communications—effectively communicates in writing

·       Other duties as assigned. 

Education and Experience: 

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

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

·       Working knowledge of current industry quality practices under QSRs, ISO-13485 and international regulations

·       Experience as a member of a design team preferred

·       Minimum 5 years’ experience in regulated environment required, previous design assurance experience preferred

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

·       Experience with usability (ISO 62366) is preferred

Training, Skills, and Certification/Licenses:  

·       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 

Work Condition:  

 ·       Must work onsite at Luminex office

·       Travel may be required at least 20% of the time; internationally

·       Possible exposure to Chemicals, Lasers, Excessive Noise, etc.

·       Physical Demands: All positions require standing, stooping, bending, climbing,

sitting, kneeling, and lifting at least 10 lbs. 

Luminex Corporation is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, national origin, disability status of an otherwise qualified individual, citizenship status, membership or application for membership in a uniformed service, or any other protected characteristic or category protected by applicable law.