Senior Design Quality Engineer - Medical Devices - Durham, NC

Are you passionate about using cutting-edge technology to improve lives? 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.

Join us in a collaborative and innovative environment where your contributions will make a real difference on impacting the lives of patients and health care providers. 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.

Skills/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.

Eligibility To Work:

• Applicants must be permanently authorized to work in the United States without the need for employer sponsorship now or in the future.
• Gilero does not offer sponsorship for employment authorizations (work visas).
• We are an E-Verify employer and confirm work authorization for all new hires.

Why work at Gilero?

Founded in 2002, Gilero, a Sanner Group company, is an international contract engineering firm that specializes in the design, development, and manufacturing of novel medical devices and drug delivery products. At Gilero, we are proud of the culture we have built that directly reflects our values of excellence, integrity, innovation, and collaboration. Motivated by our purpose to benefit people and improve patient outcomes, our team continues to grow at a rapid pace. US locations include Carlsbad, CA; Chicago, IL; as well as NC locations in Raleigh, Durham, Greensboro, and Pittsboro.

You will enjoy an 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 you start with a zero-vesting period, and access to LinkedIn learning for personal and professional development.