Collaborate with R&D and cross-functional teams to support design control requirements throughout product development and lifecycle management.
Support design verification and validation, risk management, and design reviews to help ensure applicable safety, performance, and regulatory requirements are met.
Review engineering design changes and provide quality input to ensure appropriate documentation, traceability, and risk assessment.
Support continuous improvement of design control processes, templates, and procedures to align with regulatory expectations and business needs.
Participate in sustaining engineering projects, providing quality support to maintain compliance and support product improvements.
Support complaint handling by reviewing complaint data, participating in root cause analysis, and identifying design-related trends or failure modes.
Assist in preparing quality deliverables for regulatory submissions, including 510(k)s, technical documentation, and IDE-related documentation.
Support internal and external audits by preparing relevant design history and risk management documentation.
Collaborate with Regulatory Affairs, Operations, Manufacturing, and Quality Assurance to support consistent approaches to design quality.
Support quality metric tracking and management review inputs related to design control and product quality performance.
Perform other quality-related duties assigned by management, including but not limited to supporting CAPA investigations, nonconformance (NC) evaluations, data analysis, and continuous improvement initiatives.
What Makes You Stand Out
Working knowledge of ISO 13485, 21 CFR 820, EU MDR
Experience with Design Controls and risk management
Statistical knowledge and understanding of measurement uncertainty
Detail oriented, well organized and have excellent communication skills
Able to accomplish objectives with general supervision and escalate issues appropriately
Your Background
BS Degree or higher in engineering field required (e.g., Electrical, Systems, Mechanical,Bio medical, engineering)
Experience with design, sustaining engineering, or medical device quality engineering required
Minimum 1-2 years’ experience in design, sustaining engineering, or medical device quality engineering required
Knowledge of basic regulations applicable to manufacturing in the United States.
Understanding of regulatory requirements, product registrations, compliance activities, and audit processes.
Ability to apply scientific principles and creative problem-solving to engineering challenges.
Strong knowledge of Design Controls and Risk Management, particularly related to electronic device design.
Experience with statistical analysis and statistical techniques.
Evaluate, implement, and validate design changes to existing products.
Collaborate closely with engineers to support product development workflows and processes.
Support the transfer of products and processes into manufacturing and supplier environments.
Apply scientific rationale and technical logic to support development strategies and decision-making.
Advanced Excel skills, including data analysis and reporting.
Advanced English communication skills, both written and verbal.
Travel Expectations
Yes, 40%. Occasional travel may be required to support product development activities, supplier visits, or audits.
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