Summary:
As the Sr. Design Quality Engineer you will assure new or modified products conform to quality standards and establishes compliance with the quality system. Responsible for maintaining a strong collaborative partnership with cross-functional team members that facilitates organizational success by protecting patient/user safety and meeting business needs.
Roles & Responsibilities :
• Serve on product development teams promoting and assuring quality in product development projects.
• Execute and support on-time completion of Design Control Deliverables for projects related to Design Change, Clinical and New Product Development.
• Work with cross functional team to execute and/or support various areas of Design Control processes, such as Design Input requirements, Design Outputs, Design Verification and Design Validation.
• Support the assessment/establishment of objective, measurable, discrete, and verifiable customer and product requirements.
• Support product development equipment qualification activities, inspection method development and validation activities.
• Review and approve design, development and verification/validation deliverables in compliance with FDA QSR requirements and ISO standards applicable to implantable medical devices.
• Accountable for Applicable Standards Document & checklists, Labeling Verification planning & execution, Essential Output reports, and General Safety and Performance Requirements (GSPR).
• Ensure Design History File content completion, integrity, and regulatory & standards compliance; collaboratively communicating & resolving gaps.
• Lead Risk Management activities for development projects and supplier change requests, including generation and maintenance of risk assessments, risk management plan/report, hazard analysis and failure mode effects & criticality analysis (FMECA).
• Maintain Risk Management Deliverables to ensure continued acceptability of products based on post market feedback.
• Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
• Maintain positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
• Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
• Comply with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.

Education & Experience :
• Bachelor's Degree in Engineering, Technical field OR an equivalent combination of education and work experience.
• 5+ years of previous quality engineering experience and demonstrated use of quality tools/methodologies.
• Excellent verbal, written, and interpersonal skills with ability to effectively communicate at multiple levels in the organization.
• Strong analytical/problem solving, critical thinking, and presentation skills.
• Demonstrates initiative, ownership and accountability ; plans, prioritizes and meets deadlines.
• Advanced computer skills, including statistical/data analysis and report writing skills.
• Master's Degree in Engineering or Technical Field.
• Previous Medical Device design and development experience.
• Working knowledge of FDA 21 CFR Part 820, ISO 13485, ISO 14971, EN 45502-1, ISO 14708, EU MDR, etc.