Sr. Design Quality Engineer
Core
Drive design controls, risk management, validation, supplier quality, and product release activities for MedTech products.
Role type
Senior Design Quality Engineer
Builds
High-quality medical devices and manufacturing processes
Domain
Medical Technology / Regulatory Compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Design control execution, risk management, validation planning, supplier qualification, root cause analysis, change control management, regulatory compliance, data analysis, technical documentation review, cross-functional collaboration
Preferred skills
Continuous improvement initiatives, audit support, global product stewardship, test method development, inspection criteria definition
Technologies
None explicitly stated
Responsibilities
Plan and lead Quality Engineering efforts for R&D and operations; Evaluate customer requirements and quality standards; Ensure design control requirements are executed; Lead product risk management activities; Support product release activities; Provide guidance during audits and regulatory interactions; Establish and oversee validation plans; Define global product and process control strategies; Lead failure investigations and root cause analysis; Provide technical direction to junior engineers
Seniority
Senior, hands-on IC with mentorship responsibilities
