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
• This position is in the Biotherapeutics Pharmaceutical Research and Development Devices Centre of Excellence located in Cambridge, UK. The incumbent will lead device development activities for assigned medical devices and combination products (MDCPs) from concept to regulatory approval in all intended markets, and will interact with cross functional development teams, working with all levels of employees.

The purpose of the role is to;

• 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.
• Provide support as required to regulatory correspondence, IND, BLA, NDA, and ANDA filings. (multi-market)

ORGANIZATIONAL RELATIONSHIPS

• 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)
• External designers and contract manufacturing organisations.

EDUCATION, SKILLS AND EXPERIENCE

• 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
• A practical, analytical, and pragmatic approach to work.

TECHNICALSKILLS REQUIREMENTS

• 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)
• Knowledge of medical devices, combination products, drug delivery products or needle injection systems

PHYSICAL POSITION REQUIREMENTS

• Sitting, ability to travel, driving license.

COMPETENCIES

• 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.
• Resilient Adapts or shifts priorities in response to the needs of clients, constituents, or the organization

TekWissen® Group is an equal opportunity employer supporting workforce diversity.