About Convatec

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 10,000 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. Convatec’s revenues in 2024 were over $2 billion. The company is a constituent of the FTSE 100 Index (LSE:CTEC). To learn more please visit http://www.convatecgroup.com

 

About the role

Participate in the projects to facilitate that Design control process 3706012 and Change control process 3802400 are followed properly, with a holistic view of the entire design control system.
Write and review the DHF documentation applicable in close collaboration with project team and key stakeholders to ensure compliance with standards and regulations, customers, and authorities.
Hold the responsability for Process and Product Development and Project Management located at Infusion Care. Responsible person experienced professional with substancial knowledge about the products/components.

 

Key Duties and Responsibilities

Through collaboration with multifunctional teams, lead discussions to resolve technical/ scientific challenges to support new product development of Infusion Care medical devices; define the scope of work to direct 
discussions to identify practical and theoretical solutions. 
Close collaboration with the cross functional process development team utilizing Design for Manufacturing (DFM) and Design for Assembly (DFA) methodologies to develop robust designs suitable for manufacturing 
processes including plastic injection molding, thermoforming etc.
Using existing templates, record and report experimental data. This includes reporting of the test procedure, presentation / analysis (including statistical analysis, e.g. Design of Experiments, etc.) of data and formulating 
conclusions and recommendations as a basis for further discussion and research.  
Communicate technical data including conclusions and recommendations to the wider team, make proposals and recommendations to progress the projects forward based on the analysis of this data. 
Provide technical input to support the design control process, including contributing to/ authoring design history file (DHF) documentation and material specifications.  
Maintain overall expertise by keeping updated on engineering advancements through publications, patents, university / industrial contacts and vendor discussions. 
Work effectively and proactively engage with key stakeholders at all levels to manage expectations and deliver on commitments; Understand needs and requirements across multiple functions, manage relationships to ensure effective execution. 
Work collaboratively across the organization and support colleagues to achieve shared goals and objectives. 
Lead the Design and Development of medical devices from Concept to Launch.
Direct creation of new concepts via 3D models and assemblies in CAD/CAM software (preferably Solidworks and Autocad).
Develop ideas and designs with focus on usability and user centric design.
Develop ideas and designs with focus on DFM and DFA.
Resolve concept ideas to practice through prototyping and / or other rapid simulation techniques.
Scope plan and execute / coordinate testing of prototypes.
Leading the design and development of new products in accordance with customer request and in compliance with regulatory requirements via SOPs (e.g. Design inputs, Design output, Material/Product specifications, Product drawings, Product Verification and Validation, Test method development, shelf life, biocompatibility, design transfer, design review).
Responsible for planning the order and dependencies on design control documentation according to project time plan, including transparency of completing the tasks.
Responsible for creating and finalizing DDP, DI-TM, Technical design review plan & report.
Chair and facilitate technical design reviews (agenda and minutes).
Responsible for recording and documenting the needed actions from TDRs, coordinate the actions and ensure action overview is prepared, reviewed and approved and any changes are controlled.
Ensure concordance between specific list of standards and regulation and DI-TM in cooperation with SME.
Participate at design for manufacturing and design for assembly discussions.
This Document is Confidential and Proprietary. Unless Otherwise Marked, It is an Uncontrolled Copy.
Participate on process development activities (DOE, ES) and support as R&D Engineer on process validations (OQ, PQ).
Participate in risk management meetings supporting the risk mitigations from product design requirements.
Perform activities related to DHF documentation in PDM system and DHF coordinator.
Contribute to develop and update procedures and instructions related to R&D design control.
Conduct teaching and coaching during introduction or updates on procedures and instructions related to R&D design control.
Close work and communication between Design control specialists.
Support in T&I related to decision making for CAPAs, Design Control, Change control or other processes.
Participate and support CAPA process, create NC’s and complete assigned actions.
Continuously improve processes conducted in T&I.
Prepare, review and approve of EDMS documents applicable for R&D.
To comply with the company quality policy.
Energy, Environmental, Health and Safety Responsibilities
Comply with safety, health and environmental policy, procedures established by the EEHS. 
Maintain applicable documented information related to the EEHS up to date. 
Participate in committees, trainings, and awareness, to ensure proper competency of their position if applicable. 
Be aware of and support compliance with applicable significant environmental aspects and associated significant environmental impacts. 
Understand EEHS risk and legal requirements relating to job responsibilities and appropriate requirements. 
Execute job responsibilities with professional care and in compliance with legal requirements and internal standards without compromising the safety of self and others. 
Be alert to EEHS hazards in the workplace, responding to them as appropriate and communicating them to responsible management as soon as they are identified (e.g., spills). 
Help drive continuous performance improvement in EEHS areas, recommending potential improvements to responsible management. 
Participate in identifying opportunities for improvement and implementing the necessary actions to achieve the intended results of their activities.
Design control activities planned and performed according to QMS, external standards and customer requirements.
Ensure relevant design control activities executed according to project schedule and targets.

Demands for education, training and competence

Bachelor’s degree in science and/or Engineering (or equivalent)
Experience working within Medical Device or equivalent regulated industry in an Engineering-biased role.
Experience working with relevant processes and technologies at core of ConvaTec infusion products (e.g. injection molding, adhesives, welding technologies, plastics).
Excellent communication, problem solving and analytical skills.
Ability to understand business and operational objectives and prioritize high volume and complex workloads accordingly.
Experience with product and process validation activities.
Act with a sense of urgency and take appropriate actions in conditions of uncertainty.
Knowledge of requirements of FDA's QSR, GMP and ISO 13485 or similar regulations.
Understanding / awareness of EU Regulation of Medical Devices 2017/745. (Desirable).
Ability to communicate effectively in English (verbal and written) is essential.
Good computer skills Microsoft Office (Outlook, Excel, Word, and PowerPoint).
Interpretation Course in the ISO 14001 standard, Induction in Legal Requirements in Environmental 
Matters, Training in the documents of the Environmental System, Attention and Response to Disasters, 

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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.

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