Senior Design Quality Engineer - Medical Devices

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.).
• 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.
• 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.

Requirements

• 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
• Experience using risk analysis and continuous improvement concepts
• Experience with GxP requirements
• 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

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
• Experience using risk analysis and continuous improvement concepts
• Experience with GxP requirements
• 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

Skills

• 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
• Experience using risk analysis and continuous improvement concepts
• Experience with GxP requirements
• 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

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 you start with a zero-vesting period
• access to LinkedIn learning for personal and professional development

Pay

Competitive salary commensurate with experience and qualifications.

Schedule

Full-time position.