General Description of Role:
This role will be part of the Design Quality team, which is part of the Global Quality team. The Senior Software Design Quality and Regulatory Engineer provides quality and regulatory leadership and technical expertise to global product development teams in support of software design, verification, validation, risk management, and regulatory compliance. This role ensures that all software products, whether embedded, standalone, or part of a connected ecosystem, meet applicable quality and regulatory standards throughout their lifecycle. Activities include generation and management of SOP's, generation and review of documentation, audits, participation in process improvement programs, supporting the product development teams ensuring the quality objectives are understood and achieved. The role shall ensure that software systems used in development, manufacturing, and as part of medical and non-medical devices are established according to requirements.
Responsibilities:
- Conducts Software design quality activities supporting global product development assists in the development of design concepts, prototypes and product specifications as part of the development team.
- Provides expertise and guidance to Software design verification and validation activities including definition and qualification of test methods, acceptance criteria and statistical principles. Assists in writing and reviewing protocols, reports, work instructions, and SOPs to support product and process development. Ensure compliance with IEC 62304.
- Defines and develops Software risk management activities including creation and maintenance of risk management files.
- Contributes to develop and maintain processes and controls to ensure Software safety, effectiveness and cybersecurity.
- For assigned projects, provides Regulatory guidance and defines Regulatory strategies strictly collaborating with the global RA team, ensuring compliance with applicable regulations (medical and non-medical products).
- Builds and maintains a strong and fruitful relationship with SW and global R&D for Design quality aspects.
- Drives improvements to QMS as a result of quality events, audits or regulatory changes to ensure compliance with FDA 21 CFR 820, ISO 13485, and adoption of best practices.
- Ensures compliance with Asensus quality and regulatory policies, procedures, and practices through appropriate communication, training, and education of sound quality assurance and regulatory principles.
- Contributes to cross-functional activities that support business goals.
- Supports internal audits and CAPA activities as applicable.
- All Other Essential Duties as directed.
Skills, experience & qualifications required:
- Bachelor's degree in engineering discipline. Master's degree in engineering discipline preferred.
- 5+ years in a quality or regulatory engineering role in the Medical Device field or highly regulated industry.
- Minimum 3+ years in a quality of regulatory role with focus on Software.
- Knowledge of and experience in IEC 62304 and experience with software design and validation for medical devices.
- Knowledge of the standards related to medical devices, including ISO 13485, 21 CFR Part 820 and ISO 14971.
- Understanding of design control, disciplined product development processes, regulatory and quality requirements.
- ISP 13485 inspections and FDA inspections experience preferred.
Soft Skills:
- Strong ability to problem solve and manage workload.
- Self-starter with the ability to work towards goals with little day-to-day supervision.
- Solid understanding of approaches to work breakdown, prioritization, and problem solving.
- Must be able to work well in teams cross functionally and influence teams.
- Must be comfortable presenting and explaining data/details.
- Strong ability to understand technical aspects of the product and communicate it with the relevant stakeholders.
