R&D Lab Technician

Support the product development of a cutting edge structural heart device by providing skill-set in the area of product prototyping, development, process improvements, production and testing of sub-systems / systems under the direction of Engineering.
This role will focus primarily on the maintenance of the R&D lab and associated testing requirements as part of R&D and with the additional requirement of production of the CroiValve Anchor System as part of Operations.
2 Reporting Lines
Reports directly to the Head of R&D or Operations or designate.
3 Key Responsibilities and Duties
Research and Development
Source, build and test prototypes; analyse test data and interpret to identify optimal solution.
Develop test methods for product evaluation and validation.
Lab maintenance, tracking and ordering of consumables.
Ability to do moulding, 3D printing and testing according to predefined test methods.
Prepare reports and presentations to communicate the assessments and analysis results in an easy to understand format for the understanding of others.
Generate technical documentation for the Product Design History File and Device Master Records
Ensure Quality in the product's design for durability, usability, reliability, functionality, marketability and manufacturability.
Support clinical validation to understand performance of the device in vivo.
Develop test and inspection methods in collaboration with Engineering.
Develop device assembly instructions and associated manufacturing documentation.
Production
Complete the manufacture of development, validation and clinical product in accordance with documented work instructions (adherences to GMP).
Complete all necessary in-process and final QC inspection on product per work instructions.
Lead problem solving and defect analysis as part of the production process.
Actively involved in operator training and management of training files to ensure compliance to training standards.
Manage the clean room / manufacturing environment to ensure layout appropriate for operation and environment is in compliance with specification.
Maintain Equipment folders, including ensuring necessary calibrations / preventative maintenance are performed on time.
Take responsibility for health and safety in R&D / Production areas under their control.
Ensure interactions with colleagues/stakeholders fully reflects the company values:
One Team: working together to ensure the whole is greater than the sum of the parts
Personal Ownership: deliver on commitments
Open Communication: Honest open-minded communication
Fun: celebrate the successes
Continuous Learning: at an individual and company level
Solution Orientated: Identify problems but focus your energy on solutions
Quality Focused: patient safety comes first
Technical: Has practical skills and is capable of precise workmanship with high levels of dexterity.
Has ability and interest in researching topics related to job spec to enable continuous improvement of prototyping techniques, production processes and / or testing techniques.
Management of equipment, including commissioning and organisation of ongoing maintenance and upkeep.
Problem Solving: Uses experience / knowledge of role to identify issues and introduce improvements to resolve.
Project Management: Effectively organises themselves and operators to execute defined build-plans.
Manages own time to support both production and development requirements.
Initiative: Takes initiative to drive continuous improvement of activities under their control, while collaborating effectively with R&D, Operations and Quality.
Implements methods for capturing anomalies (including analysis) during development activities to optimise device characterisation.
People Skills: Strong ability to build relationships across all levels of the organisation.
Works well with operators and identifies and resolves people issues that arise (including through escalation).
Positively influences and provides leadership to operators, sets a positive example for the operations team.
Communication: Demonstrated ability to develop training plans and effectively train operators.
Demonstrated ability to participate in production and R&D forums, including presentation of results of assigned work packages, including findings, conclusions and proposals.
5 Education and Experience
Technician level training: Level 6 or Level 7, typically with qualifications in engineering or science.
Absence of formal education can be offset by hands-on experience in an engineering science or related hands-on field.
Minimum of three (3) years of related experience in medical devices, including clean room experience.
Experience with SolidWorks or comparable CAD/3D printing software is preferred
Excellent dexterity skills.
Awareness of and on-the-job training in quality systems, risk management and ISO 13485 requirements.
Demonstrated ability to follow defined processes without deviation and ability to train operator staff to do likewise (review, teach, repeat).
Excellent people, organizational and time management skills.
Development communication skills.
Able to read, comprehend and speak English including technical terminology, in particular safety rules, operating and maintenance instructions, procedure manuals, specifications, etc.
Must be able to generate documentation and provide reports or presentations as required, especially when developing processes or providing updates on testing / investigations.
The above role profile is not designed to cover a comprehensive listing of activities, duties or responsibilities that are required of the employee.
Duties, responsibilities, and activities may change or new ones may be assigned from time to time.
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