Senior Design Assurance Engineer

About ConvatecPioneering 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 more than 10000 colleagues we provide our products and services in around 90 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. Convatecs revenues in 2024 were over $2 billion. The company is a constituent of the FTSE 100 Index (LSE:CTEC). To learn more please visit 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 more than 10000 colleagues we provide our products and services in around 90 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. Convatecs revenues in 2024 were over $2 billion. The company is a constituent of the FTSE 100 Index (LSE:CTEC). To learn more please visit About the role:Support New Product Development as well as remediation projects across Infusion Care Business Unit and other BUs as required.Support improvement projects within Design AssuranceEnsure effective Design Transfer of new products into production.Ensure compliance to EU ISO 13485 US 21CFR820 ISO 14971 and MDR and other applicable global Quality Management regulations.Your key duties and responsibilities:Leads 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.Provides leadership as subject matter expert in Design Control and actively 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.Champions Risk Management activities through leadership facilitation and active support during New Product Development 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.Drive subject matter expertise of our Design Control process as well as our Risk Management process to support the product documentation during all phases of NPD and/or remediation projects as required to support regulatory compliance and submissions.Review essential parts of the technical documentation to ensure adherence to the design control as well as risk management processes in product development projects Act as a key figure in the planning and follow-up of all design control activities.Involved in all project activities through review and approval to ensure compliance to our standard operating procedures and instructions as well as external standards and regulations.Involved in assessing developing and continuously improving the standard operating procedures instructions and templates in the context of risk management and product development.Identifies and reports opportunities for improvement to peers and management.Manage improvement projects within Design Assurance as well as coach and guide the team..Participates in CAPA-projects as well as internal and external audits as required.Takes responsibility for the measuring and monitoring of performance against agreed KPI.Skills:Preferable knowledge within in Medical Device product development (Class II)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 authorityYou communicate easily to achieve a common goal and at the same time deliver high quality and timely solutions and deliverables.You appreciate thoroughness and correctness as a natural focus of the daily work.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.Experience: Extensive experience from a similar role as Design Control Engineer or Product Quality Engineer in new product development or in remediation projects driving the design control activities within a Medical Device company.Proven 5 years experiences as Design Assurance Engineer or similar.You may have worked in a maintenance of Quality Management System (QMS) processs role looking after the process as well as technical documentation preparation.Experience gained within a Regulated Industry preferable Medical Devices. Demonstrated knowledge of Design Controls Regulatory and GxP Compliance requirements such as QSR 21 CFR Part 820 EU MDR 2017-745 GMP Parts 210 and 211 and ISO 13485.Demonstrated knowledge and experience 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.Practical experience of Notified Body audits and Regulatory Authority inspections.Qualifications/Education:Masters or bachelors degree in engineering pharmacy technical science or similar technical diploma in laboratory science.Working Conditions:This role may be based in the UK with a remote working structure.Ready to join usAt Convatec were pioneering trusted medical solutions to improve the lives we touch. If youre ready to make a real impact apply today and help us bring our Forever Caring promise to life.#LI-CC1#LI-RemoteBeware of scams online or from individuals claiming to represent ConvatecA formal recruitment process is required for all our opportunities prior to any offer of employment. This will include an interview confirmed by an official Convatec email address.If you receive a suspicious approach over social media text message email or phone call about recruitment at Convatec do not disclose any personal information or pay any fees whatsoever. If youre unsure please contact us at .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.Notice to Agency and Search Firm RepresentativesConvatec is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Convatec employee by a third party agency and/or search firm without a valid written and signed search agreement will become the sole property of Convatec. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.Already a Convatec employeeIf you are an active employee at Convatec please do not apply here. Go to the Career Worklet on your Workday home page and View Convatec Internal Career Site - Find Jobs. Thank youRequired Experience:Senior IC Key Skills Electrical Engineering,SOC,PCB,Warehouse Management,Warehouse Experience,CAD,Creo,SolidWorks,Data Mining,Digital design,Mechanical Engineering,Autocad Employment Type : Full-Time Experience: years Vacancy: 1