Design Assurance Engineering

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.

The role: You will be supporting Design & Development projects across Convatec Business Units. Supporting effective Design Transfer of new products into production. Ensuring compliance to FDA 21CFR Part 820, ISO 13485 and other applicable global Quality Management System regulations.

Key Responsibilities:

• Supports key areas for the development of new products within the New Product Development process.
• Responsible for ensuring that Design Control requirements meet regulatory and applicable procedural requirements.
• Works with the cross functional project leads to create and compile Design Control documentation as required to support regulatory compliance and submissions.
• Supports and influences development teams in the translation of User Needs to Design Inputs, Design Outputs, Design Verification and Design Validation activities, and in the execution of timely Design Reviews.
• Leads Risk Management activities, facilitation and active support during New Product Development, and post launch Change Control activities.
• Demonstrates courage to drive Risk Management in decision-making to determine sound and timely decisions that balance compliance, business, and product performance without compromising customer safety.
• Uses technical and cGxP knowledge to influence project planning and ensure quality and compliance from concept to launch.
• Provides input to post launch / lifecycle management activities.
• Works with manufacturing site teams to ensure a robust Design Transfer.
• Supports the development of comprehensive Quality Control Plans that meet the standards and requirements appropriate for the type of product.
• Participates in post launch reviews.
• Investigates product / process performance issues and participates in multifunctional evaluation of products in the market.
• Evaluates data using statistical tools.
• Where product Design Control or Risk Management is a factor, supports Complaint investigations through Root Cause Analysis and effective Corrective or Preventive Actions (CAPA).
• Supports product Change Control.
• Supports internal and supplier process audits as required to support New Product Development.
• Uses auditing as a proactive tool for improvement as well as compliance and challenges existing practice where appropriate.
• Actively contributes to and, where appropriate, supports the improvement of Quality Systems such as Design Controls and Risk Management.
• Supports opportunities for improvement to peers and management.
• Identifies and fosters relationships with key suppliers, stakeholders, relevant networks and key opinion leaders.
• Liaises with other business functions such as Quality Management, Regulatory Affairs, Clinical/Medical Affairs, Sourcing, Operations and Marketing to ensure cross functional input during the execution of New Product Development.
• Participates in the measuring and monitoring of performance against agreed KPIs.
• Collates and shares information / data through reports and follows up on identified improvement opportunities.
• To ensure compliance with the legislative and internal requirements of the EHS and to participate in the fulfilment of the company's targets in the EHS area.

Skills & Experience:

• Experience gained within a Regulated Industry, preferable Medical Devices.
• Demonstrated knowledge of Design Controls, Regulatory and cGxP Compliance requirements such as QSR 21 CFR Part 820, EU MDR 2017-745, GMP Parts 210 and 211, and ISO 13485.
• Knowledge of Medical Device Risk Management ISO 14971 and the application and use of Risk Management tools such as Hazard Analysis, FMEA and Process Mapping.
• Experience with Quality tools such as Quality Control Plans, Test Method Validation and Transfer, Root Cause Analysis, Process Validation, Process Optimization.
• Logical Thinking Skills and Experience: demonstrated ability to analyse and interpret complex problems / data gathered from a variety of sources.
• Demonstrated ability to effectively work and communicate in a cross-functional, multinational environment building cooperative 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 work and competing objectives.
• Must be proficient with PC programs, i.e. Excel, Word, and PowerPoint.

Desirable:

• Statistical knowledge and experience.
• Statistical tools (e.g. Minitab) and MS Project and SAP knowledge.
• Experience of plastics, extrusion, injection molding, assembly, bonding.

Qualifications/Education:

• Degree or proven experience in Science / Engineering.

Remote Working: Attending the office as required for training, meetings, workshops etc.

Travel Requirements: Minimal travel, less than 25%. This position may require limited Domestic and International travel to be undertaken, including overnight stays.

Our transformation will change your career. For good. You’ll be pushed to think bigger and aim for excellence. Your ideas will be heard, and you’ll be supported to bring them to life. There’ll be challenges. But, stretch yourself and embrace the opportunities, and you could make your biggest impact yet. This is stepping outside of your comfort zone. This is work that’ll move you.

Equal opportunities: Convatec provides equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, gender identity, military or veteran status, genetic predisposing characteristics or any other basis prohibited by law.