Senior Design Quality Engineer - Medical Devices - Carlsbad, CA

About the role

As a Senior Design Quality Engineer at Gilero, A Sanner Company, you'll play a crucial role in ensuring the quality development of new medical device and combination products; from ideation through transfer to manufacturing. You will be responsible for quality oversight of the design, development, and production of medical devices and combination products with a focus in the areas of risk mitigation, requirements definition, and verification and validation strategy and implementation. You'll work with multiple disciplines and clients across a wide variety of products to help shape the future of healthcare technology, ensuring products meet the highest standards and positively impact patient outcomes across the globe.

Responsibilities

• Represent Quality in cross-functional development teams, providing direction for development through transfer to production activities.
• Author, maintain, and ensure compliance of Design History File documents during the development process in accordance with ISO 13485.
• Translate user needs, intended use, regulatory inputs, and risk controls into measurable product requirements, specifications, and acceptance criteria.
• Support design verification and validation activities, including statistical approach and analysis.
• Support project related efforts with quality system elements (CAPA, Complaints, Supplier Management, External Audits, etc.).
• Participate in and facilitate risk management activities (hazard analysis, FMEAs, and risk assessments per ISO 14971).
• Ensure traceability and testability of design requirements and risk controls.
• Support manufacturing transfer, including review of preparation and execution of process validation (IQ/OQ/PQ) protocols, and development of production inspection plans.
• Investigate, disposition, and resolve nonconforming material events during product development and pre-production phases; support production phases for transferred programs as needed.
• Act as technical expert (including potential author) for new or revised QMS procedures; may include train team members, and release quality system procedures, as required.
• Support internal and external audits (particularly for projects), as required with help of broader quality management team.
• Support supplier selection, qualification, and ongoing monitoring with help of broader quality management team.
• Facilitate investigations to determine root cause and failure modes.
• Execute quality event initiation, investigation, and closure for nonconformances, CAPA, change control, and complaints as required.

Qualifications

• Able to work in the office at least 3 days a week.
• Bachelor's degree in engineering, science, or relevant field.
• 5+ years relevant work experience.
• Proficiency with FDA 820 CFRs/ISO 13485/cGMP quality management system and requirements for medical devices and/or combination product development and manufacturing.
• Proficiency with ISO 14971 and application of risk management to the development of medical devices and/or combination products.
• Experience with electromechanical medical devices and IEC 60601 preferred.
• Strong preference for experience in pharma or medical device manufacturing and/or development environment; strong preference for electromechanical systems based experience.
• Experience using risk analysis and continuous improvement concepts.
• Experience with GxP requirements.
• Experience supporting audits.
• Strong technical written and verbal communication skills.
• Excellent interpersonal, change management, planning, and organizational skills.
• Excellent oral, written, and presentation communication skills.

Personal Attributes

• Meets Gilero Core Values: Collaboration and Innovation of Excellence and Integrity.
• Productive in a fast-paced, entrepreneurial environment.
• Commits to excellence and quality service to external and internal customers.
• Adheres to established policies and procedures, while contributing to continuous improvements.

Benefits

• Annual bonus plan.
• Medical (3 BCBS plans to choose from), dental and vision.
• Company-provided life insurance, short-term and long-term disability.
• 401(k) with a match the first month after start date with a zero-vesting period.
• Access to LinkedIn learning for personal and professional development.