Principal Software Quality Engineer, Critical Care

BD recently completed the acquisition of the Edwards Critical Care business. This position is part of the Critical Care division, and as such, will become a part of the BD organization in the future. BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. If you are invited to interview for this position, a recruiter will provide further details about this exciting transition. Learn more about BD at bd.com  

The Principal Software Quality Engineer will be an essential member of the Software Quality organization.  The candidate will report into the Software Quality Director responsible for Automated Manufacturing and NPD Sustaining SWQE functions.  The candidate will execute SWQE activities to provide quality products and processes related to custom software used in manufacturing and product software in a medical device (SiMD) after commercial release. This position will provide opportunities for advancement within our growing organization. We are looking for an ambitious candidate with a strong technical background, excellent communication skills (comfortable presenting to all levels of seniority), and the ability to build trusting relationships within the organization.

How you will make an impact:

• Lead executing Software Maintenance Plans for SiMD in compliance with IEC62304 and Edwards procedures.
• Providing Product Risk Analysis (PRA) support for commercially release SiMD
• Improve and create new processes and procedures related to custom manufacturing software used to automate manufacturing processes based on latest industry trends; including IOT, AI and data-driven technologies (Industry 4.0).
• Assuring software used in manufacturing/testing equipment, computerized systems, and spreadsheets have been validated for its intended use according to Edwards processes
• Development, execution and critical review/approval of software validation documents
• Work in close partnership with business units to assure software is validated and maintained in a state of compliance to support business operations
• Ensure compliance with department and company procedures
• Train and provide guidance to teams on the software validation process
• Experience in automation framework, programming, databases, and scripting a plus
• Experience in verification activities for Equipment, Process, Software, and Test Method Validations preferred.
• Work closely with cross functional teams to drive the Digital Transformation for Industry 4.0 to advance Edwards in automation to increase efficiency and reduce cost for manufacturing through Process, Technology and People.
• Understanding of Automation, Artificial Intelligence, SCM (Software Configuration Management), and Machine Learning to support process development for Edwards transformation to Factory of the Future.
• Working in close partnership with Global Supply Chain Validation, Automation, and IT Teams to ensure custom software used in manufacturing remains in a validated state and supports business needs.
• Responsible for traceability of requirements and testing activities based on risk analysis.
• Assisting in software supplier audits.
• Supporting and providing strategic guidance to remote manufacturing plants utilizing custom software
• Effectively manage priorities, multiple projects and ability to communicate at all levels of personnel.

What you’ll need (Required Qualifications):

• Bachelor’s degree in Engineering, Computer Science, or Scientific disciplines with six (6) years of relevant experience; OR Master’s degree in Engineering, Computer Science, or Scientific Disciplines with five (5) years of relevant experience.
• Three (3) years’ experience in a regulated industry.
• Three (3) years’ experience in manufacturing equipment / test tool validations utilizing custom software.
• Excellent written and verbal communication skills

What else we look for (Preferred Qualifications):

• Familiarity with software automation or custom software used in manufacturing is required.
• Highly detailed, interpersonal skills and ability to defend software quality assurance is required.
• Solution orientated, generates multiple innovative solutions.
• Knowledge and experience in Quality Systems Risk Management (ISO 14971) and GAMP solutions and processes is preferred.
• Experience in Manufacturing or Product SiMD Software Quality, and/or V&V is preferred.
• Experience in implementing tool solutions with IT or external suppliers is preferred.
• Knowledge and/or experience with Artificial Intelligence and Machine Learning