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Role: Development Quality Engineer II
Location: Plymouth, MN
Duration: 12 Months on W2
Development Quality Engineer
Key responsibilities
Lead high visibility product development quality engineering initiatives.
Emphasis on design control file gap assessments and remediation activity for EU MDR products.
This is an individual contributor role on an engineering team.
Typical day - Perform EU MDR gap assessments for assigned products.
Analyze and evaluate product/customer risks (UFMEA, DFMEA and Hazard Analysis).
Review CAPAs, deviations and non-conformance reports to understand issues and judge appropriateness of outcomes.
Partner with R&D to create/execute new protocols and reports (test methods, design verification, design validation, etc).
Populate GSPR documentation (General Safety and Performance Requirements).
Collaborate with other functional groups as necessary to ensure timely and accurate EU product submissions.
Basic knowledge
Understand design control procedures and development processes.
Be able to identify/create technical documentation to show evidence of compliance.
Navigate Design History Files and supporting documentation evidence.
Required experience
Demonstrated ability to author protocols, reports and technical justifications (TMV/DV/Design Validation/OQ/PQ/PPQ).
Products Supported
Permanently implanted heart repair and treatment devices.
Occluders, delivery devices, surgical & transcatheter heart valve products plus accessories.
candidates need to be prepared to provide detailed examples of the type of work they performed.
process validation knowledge and experience is a requirement
Skills:
Verbal and written communication, interpersonal, team work, individual contributor, multi-task, strong organizational, advanced computer skills
Education: Bachelor level degree in an Engineering Discipline or other technical field experience
Regards,
Norman Wick | Technical Recruiter
Intellect Inc
Desk: 551 314 6454 Ex: 152
Email: : Norman@intellectt.com
Website: (link removed)
Intellectt INC
