OVERVIEW:
Be a part of the Quality team at our Healthcare Optics Research Laboratory and drive Quality for the development of unique software based biomedical devices in collaboration with world leading medical institutions. We are seeking an experienced Medical Device Senior Software Quality Engineer (Sr Engineer, Software Quality Assurance) who can lead software design assurance and risk management activities and provide quality support of software development lifecycle processes and drive compliance.

RESPONSIBILITIES:
• Ensure that software deliverables including software requirement specifications, software development plans, software architecture documents, and software verification and validation plans are compliant to software development lifecycle process procedures
• Act as a member of Issue Review Team meetings to ensure that software bugs are evaluated and addressed appropriately
• Provide guidance on the selection of statistical analyses and sample size for design verification and validation and other qualification and acceptance testing
• Support the successful transfer of products to manufacturing by ensuring the adequacy of process validation, design transfer plans, quality plans and supplier documentation
• May plan and execute internal audits against applicable quality system standards, regulations and internal procedures.

QUALIFICATIONS:
• Education: BS or higher degree in engineering, or similar
• Experience: 5 years minimum experience with a minimum of 3 years of Medical Device experience and a minimum of 3 years of Quality experience or design control experience, including experience in leading design control and risk management activities
• In-depth understanding of medical device design control and risk management
• Working knowledge of the requirements of FDA QSRs, ISO 13485, IEC 62304, IEC 60601 and ISO 14971
• Experience with JIRA/JAMA software tools and their implementation is a plus
• Certification as an internal lead auditor for QSRs and/or ISO 13485 is a plus
• Skills: Proficient in Microsoft Office. Experience in Minitab, JMP or similar statistical package

HYBRID: 

This position offers a hybrid work schedule requiring you to be in the office 2 days a week and an option to work from home 3 day out of the week (unless a specific business need arises requiring in office attendance on other days). Note that work schedules and office reporting requirements may change from time to time based on business needs.