Senior Product Quality Engineer (software and/or hardware)

Pioneering trusted medical solutions to improve the lives we touch: Convatec is a global medical products and technologies company, focused on solutions for the management of chronic conditions, with leading positions in advanced wound care, ostomy care, continence care, and infusion care. With around 10,000 colleagues, we provide our products and services in almost 100 countries, united by a promise to be forever caring. Our solutions provide a range of benefits, from infection prevention and protection of at-risk skin, to improved patient outcomes and reduced care costs. Group revenues in 2022 were over $2 billion. The company is a constituent of the FTSE 100 Index (LSE:CTEC). 

About the Role:

Ensuring the Design Assurance of new products integrating software & hardware and processes to support the growth of Convatec’s Digital portfolio, as well as providing ongoing support for the maintenance of Design Documentation throughout the product lifecycle. The ideal incumbent will work in a hybrid capacity out of our Technology and Innovation Center in Lexington, MA.

Key Duties and Responsibilities: 

• On New Product Development, leads key Software and Hardware 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, IEC 62304 Medical Device Software Development and IEC 60601-1. 

• 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 and hardware 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 and hardware products and contribute to the continuous improvement of the Risk Management Policy and procedures. 

• Contributes as a subject expert in Software and Hardware Design Controls and 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 and/or hardware 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 and hardware 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 and Hardware Design Assurance.  

• Participates in Corrective and Preventive actions relating to Software and Hardware Development and Risk Management arising from internal audits, external audits and product failure investigations. Supports the local CAPA Review board.  

• Collaborates with both internal project teams, third party software developers and third party electrical/mechanical engineers (ME/EE), 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.  

Principal Contacts 

• Internal: R&D, Digital Solutions, Information Technology, Regulatory Affairs, Clinical Affairs, Marketing, Production, Other Corporate Quality functions, etc. 

• External: Competent Authorities and Notified Bodies, External auditors (contracted by CvT), Third party suppliers and manufacturers, etc.  

Travel Requirements: Yes. This position requires some Domestic and International travel to be undertaken, including overnight stays. Driving license required. 

Language Skills Required: 

The ability to communicate effectively in English (verbal and written) is essential.  Ability to communicate effectively in additional languages would be advantageous but not essential.  

About you 

Required: 

• Degree (or equivalent) in Science or Engineering required. Membership of a professional institution is desirable.  

• Minimum 5-8 years in science / engineering with minimum 3 years supporting the development of new products integrating Software and Hardware

and QMS activities in the Medical Device or Healthcare industry. 

• 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, cybersecurity, IEC 60601-1, ISO 13485 & ISO 14971. 

• Demonstrated knowledge of Design Control processes for Medical Device Software and/or Hardware Development. 

• Demonstrated knowledge and experience of Risk Management and the application and use of Risk Management Tools in compliance with ISO 14971, EN/IEC 62304 cybersecurity, and IEC 60601-1.  

• 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. 

• Experience in Cybersecurity Risk Management for Medical Device Software and Hardware Development. 

• Logical Thinking Skills and Experience: demonstrated ability to analyze and interpret complex problems / data gathered from a variety of sources and utilize. 

• 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.  

• Ability to work without close supervision and produce quality work. 

• 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. 

• Quality Auditing experience (ISO 13485) 

Desirable: 

• Exposure to development of Software as Medical Device as healthcare app or/and Software in Medical Device with electronic and wireless connectivity 

• Experience in AAMI TIR-45 standard.  

• Design for Six Sigma knowledge, experience and certification  

• Experience of software or hardware development 

• Experience in Project Management