Senior Software Quality Engineer

About the role

Talented Engineer with a background in Software Quality needed to join Gilero's team where we help bring life-enhancing products to market efficiently and effectively. You will be responsible for leading software quality project and company activities for medical device and drug delivery applications.

Responsibilities

• Lead medical device software quality and test team activities internally and externally.
• Lead software verification and validation activities for products under development in accordance with company procedures.
• Author and approve software test case protocols and reports, software development plans, and other system/software documentation.
• Lead software development projects from product classification, software requirements, development, verification and validation through regulatory clearance.
• Participates and leads software unit, integration, and system verification testing.
• Has experience reviewing Software Architecture and Software Design documentation.
• Provide Quality oversight of software plans, software development, verification, maintenance, and storage.
• Perform risk evaluation and associated management activities related to software development including hazard analysis, FMEA, product risk analysis and mitigation, software safety classification, and basic or enhanced documentation.
• Perform risk evaluation and associated activities related to medical device cybersecurity including threat model, cybersecurity risk analysis and evaluation, including cybersecurity design controls.
• Prepare documentation for regulatory filings, including technical file and 510(K).
• Provide mentorship and guidance to engineers involved in software quality activities.
• Support Gilero’s growth through scaling internal and external software quality resources.
• Identify and implement improvements to the Quality Management System, software development lifecycle and testing practices within the company.
• Participate as team member on new product development projects as quality function representative. Provide support for product and process development activities.
• Maintain a strong, collaborative partnership with cross functional team members.
• Lead internal corrective and preventative actions (CAPA) process and perform effectiveness checks as appropriate, as needed.
• Perform process validations (IQ/OQ), as applicable, including test or other equipment utilizing software, user controls and data management, as needed.
• Support internal and external audits, as needed.
• Support non-product software validation by assessing the need for validation and preparing test scripts and executing protocols, writing reports and other documentation, as required.
• Support company compliance to 21CFR Part 11 compliance and data integrity policies.

Requirements

• Minimum: Bachelor's degree in engineering, science, or relevant field
• 5-10 years in regulated manufacturing and/or development environment
• Proficiency with FDA 820 CFRs/ISO 13485/cGMP quality management system and requirements for medical devices and combination product development and manufacturing
• Expert with IEC 60601-1, IEC 62304, and FDA software development guidelines
• Expert using risk analysis and continuous improvement concepts
• Extensive experience with GxP requirements
• Strong technical written and verbal communication skills
• Experience leading and/or supporting audits
• Preferred: Master's or advanced degree in relevant field
• 10+ years in pharma or medical device manufacturing and/or development environment
• Excellent interpersonal, change management, planning and organizational skills
• Software lifecycle management expertise in phase appropriate environments ranging from pre-clinical to commercial
• Expert with IEC 81001-5-1, ANSI ISA 62443-4-1, and FDA pre-market and post-market cybersecurity guidance
• Project management experience
• CSWQE ASQ or related certification

Skills

• Minimum: Bachelor's degree in engineering, science, or relevant field
• 5-10 years in regulated manufacturing and/or development environment
• Proficiency with FDA 820 CFRs/ISO 13485/cGMP quality management system and requirements for medical devices and combination product development and manufacturing
• Expert with IEC 60601-1, IEC 62304, and FDA software development guidelines
• Expert using risk analysis and continuous improvement concepts
• Extensive experience with GxP requirements
• Strong technical written and verbal communication skills
• Experience leading and/or supporting audits
• Preferred: Master's or advanced degree in relevant field
• 10+ years in pharma or medical device manufacturing and/or development environment
• Excellent interpersonal, change management, planning and organizational skills
• Software lifecycle management expertise in phase appropriate environments ranging from pre-clinical to commercial
• Expert with IEC 81001-5-1, ANSI ISA 62443-4-1, and FDA pre-market and post-market cybersecurity guidance
• Project management experience
• CSWQE ASQ or related certification

Benefits

• Annual bonus plan
• Medical (3 BCBS plans to choose from)
• Guardian 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

N/A

Schedule

N/A