This position is responsible for product software quality assurance support of new product development projects and design changes.   This individual will ensure design control requirements are implemented and followed, will support multiple product development projects with a primary focus on software projects. This individual will ensure that the quality objectives are met during the product development and design transfer life cycle.  This individual will also be responsible for assessing manufacturing changes ensuring both the design integrity and process control requirements are fulfilled.  

This position is responsible for performing tasks that will assure a high level of product reliability along with regulatory compliance and provide technical direction to company staff on matters of quality and compliance throughout the product’s lifecycle. This position will work with Development, Operations, Manufacturing, Regulatory, Quality and other functional areas globally to ensure work is completed in accordance with company procedures and geographic regulations.  

Company Profile 

Client is a growing medical device company that offers innovative implantable devices.

Primary Responsibilities:  

• Partner with Development to generate project deliverables and conduct audits of the deliverables prior to product release.
• Ensure design history content integrity, completeness, and regulatory / standards compliance; Collaboratively communicating & resolving gaps with cross-functional team members.
• Provide product software design assurance services, including planning for software design validation, design transfer, test system development and validation., Including active cross-functional root-cause analysis investigation and resolution.
• Partner with Development on the validation of software test environments and software tools, including test methodology, test protocol and acceptance criteria development.
• Support and/or lead risk management activities from product concept through commercialization. 
• Product expertise and guidance on global medical device software and security standards or other specific industry standards to ensure compliance with those standards.  Lead and document standard updates and compliance reviews at the prescribed frequency.
• Provide quality engineering support for design changes, sustaining engineering projects and when applicable supplier changes.
• Work within a cross-functional team to identify and implement effective controls and support product development from concept through commercialization.
• Ensure quality system procedural requirements and development life cycle phases are followed.
• Ensure proper cyber security testing and controls are utilized and documented. 
• Generate and/or approve the following:   DHF deliverables, Engineering Change Orders (ECOs), Risk Management documents and Device Master Record (DMR) deliverables.
• Provides project direction, coaching, and mentoring for engineering and technical team personnel to ensure best-in-class Software Design Quality Engineering practices.
• Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
• Support both internal and external audit activities.
• Support other quality projects and initiatives as assigned. Document product and therapy related field reports within the prescribed timelines and provide any necessary documents required to complete the investigation.  Provide follow-up reporting as needed.
• Complete training requirements and competency confirmations as required for this position within the required timeline.
• Comply with applicable quality system procedures/policies and make suggestions for continuous process improvement. 

Required Qualifications:

• Bachelor’s degree in a technical or scientific field.
• 6 – 10 years minimum experience a medical device software quality or software design assurance role for finished medical devices.
• Comprehensive knowledge on medical software device design standards along with global regulations for medical device software design.

Preferred Qualifications: 

• Bachelor’s degree in an engineering discipline such as computer science, electrical, mechanical, software or biomedical.
• Master’s degree in a technical or scientific field.
• Experience with cloud infrastructure.