SR Software Quality Engineer - Medical Devices

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. directing, managing, and maintaining the development, validation and control of medical device software products, such as embedded software (SiMD), applications, and software as a medical device (SAMD). You will lead embedded software project activities for medical device and drug delivery applications., * 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.

• 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

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.

Gilero is a trusted partner for medical and drug delivery device development, offering expertise in design, development, and manufacturing solutions. We have a passion for innovation and a commitment to excellence with a broad range of projects and technical expertise. Join our team and contribute to improving lives worldwide., 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), 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, and access to LinkedIn learning for personal and professional development.