Responsible to assure Quality and Compliance, and provide overall Quality guidance during software development and validation of embedded software in the surgical devices
Reviews and approves design and development planning documents and design change requests.
Reviews and approves product requirements, system requirements, software requirements specifications, software architecture specifications, software detailed designs requirements using requirements traceability analysis.
Reviews and approves Risk Management documentation.
Review and approve Software Integration Test, Software System Test and Design Validation Test protocols and reports.
Reviews and approvals ensure document deliverables with internal directives and SOPs and external industry standards and regulations.
Influence the requirements definition and software design to maximize quality of requirements.
Act as a process advisor to coordinate risk controls, specification traces, verification / validation testing, and anomalies tracking for resolution.
Work closely with the software development team in risk management.
Collaborate with other engineering disciplines, such as mechanical, electrical, and industrial design, to ensure that embedded software will accomplish design goals for a particular product.
Help guide R&D teams through Quality Management System to ensure software is developed in compliance to internal procedures, as well as the requirements of FDA, ISO, and other regulatory bodies.
Develop a software validation strategy for new designs and development of surgical devices.
Create documented body of knowledge (BOK) to drive a compliant application of software when innovative designs and technologies are adopted and/or developed. (e.g. apps and clouds).
Maintain current procedures or develop and implement new procedures (SOP), work instructions, templates and other documentation, to ensure software is in compliance to International Standards and Regulations.
Responsible to defend in any Quality audits and Regulatory inspections the Design Quality aspect of the products under his/her responsibility.
Provides coaching and training on critical Quality procedures and practices to entry level Design Quality Engineers and/or contractors as part of their onboarding process.
Perform assessments of Quality processes and procedures relative to product design and development, in order to identify potential inefficiencies, and where needed, propose and implement changes to improve those processes.
Scope of the referenced key activities and responsibilities is primarily project-based, with extended scope for the development and/or update of procedures, work instructions, forms and templates required to execute this role.
Thorough understanding of software quality assurance principles, practices and metrics, as well as best practices that foster high quality software.
Deep knowledge of embedded software testing
Excellent analytical, problem solving, organizational, and communication skills
5+ years in the field of software with at least 3 years of hands on experience in a technical Quality role supporting a product design function in the development, testing, validation, approval and release of embedded software in medical devices hardware.
Demonstrated work experience in a role within a Design Quality function with responsibility of Quality Assurance and Compliance for device software in FDA regulated products.
Proven record supporting the development and execution of software test protocols for complex medical devices.
Familiarity with EN 62304, EN ISO 14971, EN 62366, FDA regulations and international standards applicable to medical device design, development, verification and validation.
Working knowledge of FDA guidance for Medical Device Software Validation
Former experience as a software developer using C, C++, C#, APIs, or equivalent.
Worked with teams on 510(k) submissions and/or PMAS.
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Bausch & Lomb