Device Development Lead
4 days ago
Cambridge
Overview: TekWissen is a global workforce management provider throughout the UK, Europe and many other countries in the world. The below client is an American multinational pharmaceutical and biotechnology corporation. Job Title: Device Development Lead Location: Cambridge Job type: Contract Duration: 23 Months WorkType : Onsite Job Description: JOB FUNCTION: • Engineering, Project Engineering, Project Mangement, • To lead multi-disciplinary project teams within the Devices Centre of Excellence (DCoE) in the development of drug delivery devices and life cycle management activities according to established procedures and processes, • To liaise across the client with drug product development, co-development and manufacturing teams in the introduction of drug delivery devices and life cycle management activities, • To manage design development activities at external vendors in coordination with industrialisation activities, • To manage project activities to meet specified targets for quality, cost and schedule, • To provide coaching and mentorship to support the development of project team members All Grades, • To be accountable and responsible for all aspects in the development of drug delivery devices and life cycle management activities according to agreed processes, • To lead, manage and co-ordinate the activities of DCoE colleagues and external partners with respect to;, • Project Scope and Deliverables, • Device Specification, • Design Development, • Concept Evaluation, • Design Control, • Risk Management, • Device Industrialisation, • Design Verification, • Design Validation, • To apply design control and risk management to all device projects and to support all DCoE Cambridge personnel in ensuring compliance to the client policies and procedures., • To support the DCoE device design change controls system and work with relevant colleagues to satisfactory implementation, ensuring that quality and regulatory requirements are satisfied, • To support for the generation and approval of project and departmental budgets, • To support long range resource planning activities, • To support the multi-disciplinary team to determine what performance factors of the drug delivery device will require assessment and investigation., • To provide input to supplier specifications for devices and device components, • To provide input and support to human factors usability studies, • To support device design and manufacturing investigations from devices used in clinical trials and commercial manufacture, • To support the timely completion of complaints related to technical issues associated with devices used in clinical trials and commercial manufacture, • To ensure familiarity with all appropriate documentation (SOPs, instruction manuals, risk assessments, etc.) so that all appropriate experimental/manufacturing related activities are conducted in accordance with approved safe working practices (ensuring use of PPE where appropriate) and GxP procedures as required., • To support the assessment of external design companies and suppliers for capability of quality systems, facilities and procedures to support device development and supply, • To identify and evaluate current and future industry trends to anticipate future business requirements., • To be a device technology subject matter expert (SME) internally and externally, • To support SMEs in the device development process., • Device development teams –device development SMEs (including human factors engineers, design engineers, industrialisation engineers and device development scientists)., • Co-development team – drug product and device SMEs., • Quality Assurance, • GCMC (Regulatory), • PGS – manufacturing sites and post launch device team., • Global Technical & Engineering (GT&E), • Degree, HND or equivalent in relevant engineering or other technical discipline, • Experience leading multi-disciplinary teams in the development of combination products or medical devices with at least 8-10 years experience, • Able to prioritizse multiple responsibilities and to work on multiple tasks simultaneously, • Experience of planning product development programs from concept through to commercializsation., • Experience with principles of device design control as well as knowledge of ISO13485, GMP, ISO14971,ISO62366 and global regulatory requirements such as EU Medical Device Regulations, • Experience in the preparation of device sections of BLAs, MAAs, INDs, IMPDs and CTDs for global markets., • Maintain an up-to-date awareness of advances in quality systems, regulatory requirements/expectations as they relate to device and drug product development., • Strong communication skills; capable of articulating ideas and concepts clearly and concisely with internal and external team members, • Knowledge and experience of mechanical, product or production engineering or other relevant technical discipline, • Knowledge and experience of product development processes from concept to launch (Required), • Knowledge and experience of project planning tools and techniques (Required), • Knowledge of Design Control principles (Required), • Knowledge of ISO13485 (Required), • Knowledge of using risk assessment tools including FMEA (Preferred), • Knowledge of injection molding (Preferred), • Knowledge of automated equipment for assembly and/or testing (Preferred), • Decisive Is an agile learner who synthesizes complex information to determine the best course of action., • Focused Holds self and others accountable for consistently meeting needs of customers and stakeholders., • Connected Builds effective professional relationships with internal and external stakeholders., • Courageous Shows consistency between words and actions, gaining people's trust and respect.