Working for an award winning manufacturer with an outstanding reputation this is a technical engineering role to develop and sustain high quality medical devices. Responsible for the evaluating, planning, prioritisation and execution of engineering activities for sustaining existing medical devices. To work in close association with Development, Manufacturing and Business Development personnel and external partners and subcontractors to ensure the highest levels of quality, reliability and manufacturability are achieved.
Tasks and Responsibilities
- Full project lifecycle ownership; Planning, prioritising, identifying requirements, testing/validation, manufacturing implementation.
- Developing evidence for compliance with the relevant BS, EN, ISO ASTM standards to support regulatory submissions and audits.
- Interpret design inputs for traceability, translate into verification and validation activity including relevant standards, and establishment of acceptance criteria.
- Manage multiple sustaining projects, with accountability for meeting all parameters including cost, schedule and performance targets
- Lead and participate in cross functional teams, managing the interface between all team members, stakeholders and global suppliers.
- Responsible for the compilation of all device elements of the regulatory files
- Generation of appropriate technical and project documentation including specifications, design and phase gate reviews, technical reports, risk assessments & design history documentation, to support project requirements and business goals.
- Work with Design assurance to develop and undertake test plans and procedures for verification and validation testing.
- Hands on engineering approach, building and testing pre-production units and samples, drawing appropriate and qualified conclusions
- Apply a hands on, systematic problem-solving methodology to identifying, prioritising and resolving problems.
- Lead and implement product risk management activity throughout the project, including FMEA, Hazard Analysis, Risk management plans. Drive risk management in decision making to determine sound and timely decisions that balance compliance, business and product performance.
- Apply LEAN manufacturing and DFM/DFMA principals
- Identify opportunities for continuous improvement of the engineering/ product development process coincident with project execution (speed, discipline, quality outcome), and work with colleagues to embed changes in Standard Work, templates, etc. to sustain the change.
- Keep abreast of new technologies, processes and materials developments to ensure the organisation continues to lead in its sector
Essential Skills and Experience:
- A minimum 5 -10 years’ experience of mechanical engineering, at an advanced level with a track record in project engineering.
- Minimum HND (ideally degree qualified or equivalent) in Mechanical and/or Design Engineering
- Proven Project Management and / or Project Engineering experience and can demonstrate having led and successfully delivered technical projects.
- Demonstratable experience of the development, manufacture, testing, and the quality control of medical devices
- Experience with global submissions, agency interactions and authoring technical files
- Excellent communication and inter-personal skills, both written and oral, with the ability to communicate at all levels
- Strong time management and organisational skills
- Performance driven, driving for results and success with a sense of urgency
- Demonstrate problem solving skills and utilisation of different strategies to support resolution of design, manufacturing and regulatory challenges
- Comprehensive knowledge of the following standards, in particular product design controls, development lifecycle, risk assessment, and validation.:
- ISO 13485
- ISO 14971
- FDA 21 CFR 820
- Excellent analytical, problem solving, organisation skills with experience in root cause investigation and tools.
- Exercise good judgment in elevating and communicating actual or potential issues to management
- Good understanding of manufacturing and processing techniques such as injection moulding, machining etc.
- Excellent technical writing skills including advanced use of MS office-based programs.
- A practical individual with a hands-on approach to resolving problems
- Creative, independent thinker with good judgement that can take the initiative & owns a project and/or problem until resolution
- Produce high quality work with emphasis on detail and accuracy
- Willing to further knowledge, skills and competences through study, training and personal development
- A team player who operates with integrity at all times
- Pro-active, flexible and committed
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