Senior Software Design Quality Engineer

About the role

The Senior Software Design Quality Engineer role supports various New Product Development and sustaining activities, plays a key role in product risk management, cybersecurity, change controls, test reviews, and design controls. This position requires a self-motivated engineer with excellent written and verbal communication skills.

Responsibilities

• Drive quality focused design and development of software within the software development lifecycle (Agile/waterfall/SAFe/DevOps) by defining the requirements, design, verification and validation plan and strategies while maintaining traceability.
• Use Software as a Medical Device (SaMD) and Software in a Medical Device (SiMD) technical expertise, knowledge, and experience to rapidly innovate the company’s medical devices for use in chronic heart failure patients.
• Lead and conduct risk management activities including development of Risk Management Plans, Hazard Analyses, Software Failure Modes and Effects Analysis (SFMEA) and Risk Management Reports.
• Ensure that Design Controls are compliant with IEC 62304.
• Ensure that FDA and other regulatory knowledge and experience is applied to risk management, software development and testing.
• Participate in software development sprint cycles by supporting the software development team through attending SCRUMs, design reviews, code reviews and providing feedback on software verification and validation deliverables.
• Develop and/or review test protocols, reports, and engineering summaries.
• Participate in product cybersecurity activities including product security planning, threat analysis, cybersecurity risk assessments, periodic monitoring and reporting.
• Review and approve Change Requests as needed to release software revisions to production/field.
• Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues as related to the position responsibilities.
• Drive the success of the Quality System performance measures by completing tasks on time and with a high level of Quality.
• Support 3rd party audits, including follow-up on actions.
• Drive compliance of QMS through authoring and updating Standard Operating Procedures (SOP).

Qualifications

• A minimum of a Bachelor's degree in an engineering or scientific discipline is required. An advanced degree in a related field is also an asset.
• Minimum of 5 years of related work experience within the medical device industry on SaMD and SiMD systems.
• Experience with quality engineering under quality system regulations, including but not limited to 21 CFR Part 820, ISO 14971, IEC 62304, QSR, ISO 13485, MDSAP and/or MDD/MDR.
• Experience with software development lifecycle processes (waterfall, agile, and DevOps) as applied within the regulated medical device industry.
• Ability to communicate ideas and information clearly, effectively, and frequently (oral and written) within the internal project team and internationally.

Preferred Skills

• Experience with Class III medical device capital equipment development.
• Experience with owning, conducting and maintaining risk management activities, including the risk management file.
• Experience with JAMA and Atlassian suite of tools (JIRA/Confluence).
• Experience with cybersecurity within a regulated industry.