- Reference: GY45836AO
- Job Type: Permanent
- Location: Galway
- Category: Production
Key responsibilities include the following:
• Implementing the manufacturing build plan with subcontract manufacturer to meet device demand.
• Provide technical and QA line support to the manufacturing line.
• Proactive monitoring of line efficiency, performance and output
• Ensure manufacturing activities are managed in accordance with the company’s quality
system and policies, including diligent recording of results and writing reports.
• Identify and implement opportunities for improved efficiency.
• Establish new manufacturing lines and/or cleanroom space to facilitate the introduction of new product lines
• Define and refine assembly methods and process settings
• Periodic review of validations as required in accordance with Quality System requirements.
• Completion and review of process risk analysis and ongoing dedication to risk reduction
• Leading role in risk management and disaster planning.
• Write procedures, protocols, specifications, and reports.
• Provide design for manufacture feedback/support to R&D team during new product development phase
• Maintain traceability of all finished good products
• Equipment specification, procurement, calibration, and maintenance
• Managing and mentoring direct reports, where relevant.
• Representing the company externally, for example at physician line tours.
• Liaise with component and service suppliers on delivery schedule and any quality problems
Key Relationships / Interfaces
• Manufacturing leadership and team.
• Quality and Regulatory personnel.
• Manufacturing subcontractor.
• Marketing and Sales teams.
• R&D team
• Component and equipment suppliers.
• Service suppliers.
Key Skills / Experience
Minimum education of mechanical or biomedical engineering degree or equivalent.
• Typically 5 years’ experience in the manufacturing/design/development of medical devices.
• Strong understanding of basic engineering principles.
• Strong problem solving capability.
• Ability to work well under deadlines and pressure
• Ability to communicate clearly, accurately, and directly, both verbally and in writing, to a widely varied audience.
• Able to work on own initiative and as a team player.
• Good planning and organisational skills
• Clear communicator
• Good judgment and problem solving ability.
• Able to build good, strong and positive working relationships with cross functional teams internationally.
For a confidential discussion and more information on the role/company please email your CV to: firstname.lastname@example.org