A newly created position to lead Software Design Assurance for our Medical Device client focussing on developing new products incorporating SaMD / Connected Devices! This position will offer remote working and the opportunity to make your mark in a new area for the business.
- Remote working
- 10% Bonus
- Pension scheme
- 25 days annual leave, plus bank holidays
- Rare opportunity to shape a new role for SaMD/Connected Devices
- Leads key Software Design Assurance activities to ensure an efficient pre-production quality assurance program for design & development.
- Acts as a Subject Matter Expert for Medical Device Quality Management System regulations and standards, including ISO 13485 and 21 CFR 820, with a focus on 21 CFR 820.30 Design Controls and IEC 62304 Medical Device Software Development.
- Experience in establishing and maintaining a Quality Management System for Medical Device Software solutions, including the creation and maintenance of procedures, work instructions and templates to enable global product launches.
- Serves as an expert for software lifecycle Risk Management demonstrating a thorough knowledge and understanding of EN ISO 14971 and IEC 62366. Must be able to lead and perform risk management activities for software products and contribute to the continuous improvement of the Risk Management Policy and procedures.
- Contributes as a subject expert in Software Design Controls and Software Development Lifecycle Phases. Is experienced in following both agile and waterfall methodologies and actively supports and advises the development teams throughout the lifecycle management of the product.
- Actively participates in and facilitates the development, review and approval of requirements and deliverables required to support product software development (planning, requirements, architecture, verification/validation etc.) including maintenance, configuration management and problem resolution.
- Supports Software Development Lifecycle activities by providing guidance and direction to change originators assembling documents such as Change Control Records.
- Provides clear direction on all quality activities necessary for the business to develop and maintain new software products. Specifically, deliverables related to product safety, usability, risk management, compliance, and product performance.
- Builds effective networks and processes with broader Engineering community (ie. Site Quality, Process Engineering etc) peers, suppliers, customers and key stakeholders.
- Demonstrates flexibility, open-mindedness, and adaptability to changing environments. Uses technical skills and experience to reach clear and logical decisions.
- Participates in inspections by regulatory bodies, such as FDA and International Notified Bodies acting as an SME for Software Design Assurance.
- Participates in Corrective and Preventive actions relating to Software Development and Software Risk Management arising from internal audits, external audits and product failure investigations. Supports the local CAPA Review board.
- Collaborates with both internal project teams and third party software developers, ensuring compliance to regulations, practices and policies. Interprets regulations and maintains an awareness of industry trends on compliance issues. Implements measures to anticipate and avoid regulatory violations.
- You'll hold a Degree or proven experience in science / engineering and with experience of Software Development.
- Demonstrated knowledge of Regulatory and GXP Compliance requirements such as QSR Part 820, MDD 93/42, GMP Parts 210 and 211, EN/IEC 62304, IEC 62366, ISO 13485 & ISO14971.
- Demonstrated knowledge of Design Control processes for Medical Device Software Development.
- Demonstrated knowledge and experience of Risk Management and the application and use of Risk Management Tools in compliance with ISO 14971 and EN/IEC 62304.
- Experience with Quality tools such as Quality Control Plans, Test Method Validation, Statistics, Experimental Designs, Root Cause Analysis, Process Validation, Process Optimization.
- Demonstrated knowledge and experience in following both agile and waterfall software development methodologies, including experience in AAMI TIR-45 standard.
- Experience in Cybersecurity Risk Management for Medical Device Software Development
- Logical Thinking Skills and Experience: demonstrated ability to analyze and interpret complex problems / data gathered from a variety of sources.
- Demonstrated ability to effectively work and communicate in a cross-function, multinational environment, building co-operative working relationships. Demonstrated ability to work effectively with multi-cultural and diverse suppliers and contract manufacturers.
- Good interpersonal skills and ability to influence people without direct authority.
- Proactive and flexible in adapting to changing environment and able to manage and prioritize team workload and competing objectives.
- Design for Six Sigma knowledge, experience and certification are desirable
- Must be proficient with PC programs, i.e. Excel, Word, and PowerPoint. Statistical tools (e.g. Minitab) and MS Project and SAP knowledge desirable.
- Experienced with a range of software development tools.
Austin Fraser is acting as an Employment Agency in relation to this vacancy.
Austin Fraser is committed to being an equal opportunities employer, and encourages applications from candidates regardless of sex, race, disability, age, sexual orientation, gender reassignment, religion or belief, marital status, or pregnancy and maternity status.
Due to the volume of applications received, we are unable to provide individual feedback to unsuccessful applicants.