R&D Technical Manager
- Employer
- Manpower Ireland
- Location
- Galway
- Salary
- Negotiable
- Closing date
- 12 Nov 2021
View more
- Sector
- Manufacturing
- Job Type
- Contract
- Hours
- Full-time
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R&D Manager (Part Time - 12 Months)
Job Description
Main Duties/Responsibilities
- Manage the R&D team responsible for MDR remediation and sustaining activity of existing products.
- Provide Technical direction to team critically analysing and distilling applicable requirements into clear goals & objectives for all Team members.
- Work as member of site MDR steering Team to plan, organise and review site MDR program activity ensuring that progress is maintained to achieve submission approval milestones and business continuity.
- Liaise and work effectively with Sales & Marketing, Regulatory, DA, QA, Operation, Planning and other critical functions to form a cohesive project Team ensuring all inputs and requirements are considered, included in project scope.
- Organise and provide direction and input on execution of design control activities such as User requirement review, risk analysis, product specification, Human Factors analysis, test method development/validation and Design Verification & Validation in order to successfully bring product to regulatory submission stage.
- Organise, review and sign off required Engineering and Design documentation in line with the Quality Management System and associated regulatory requirements.
- Foster an environment of continuous improvement in all aspects of R&D from design systems& documentation through to technology and process development.
- Performs other related duties and tasks as required.
Minimum Qualifications/Competencies:
- Degree in Engineering, Science, or related technical field or with appropriate demonstrated experience.
- At least 10years previous related experience in med device product development with a minimum of 5 in a technical personnel management role.
- Experience in interpretation and application of MDR requirements in Med Device development.
- Strong interpersonal and organizational skills and the ability to work effectively as a team leader.
- Demonstrated analytical problem-solving and innovative thinking.
- Good working knowledge of medical device materials and processes.
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