Technical Lead - Process Development and Manufacturing
This is a permanent hybrid role based in Carrigtwohill, Cork. The position involves independently determining and developing approaches to technical problems of moderate scope and complexity.
Key Responsibilities:
* Determine and develop approaches to various technical problems of moderate scope and complexity.
* Use the latest engineering techniques to reduce product time to market while adhering to regulatory requirements, project deadlines, and product costs.
* Build productive internal and external working relationships and may periodically provide guidance and training to other team members.
Main Areas of Responsibility:
* Process development and characterisation of machining & manufacturing processes for R&D / NPD on multi-axis CNC machines.
* Create production programs (G code / CADCAM), conduct experimental tests, and analyse results to establish optimum process operating parameters.
* Lead and/or participate in process review meetings.
* Work with tooling suppliers to identify and optimise tooling and fixturing for CNC manufacturing processes.
* May lead/support capital acquisition activity from specifying equipment, testing, liaising with equipment / component suppliers.
* Input into process technology road-mapping activities and drive innovation to ensure alignment with future planned product launches.
* Work with quality & metrology engineers to develop component specific testing and inspection protocols.
* Participate in PFMEA, Control Plan, SOP, and PPAP generation associated with product launches.
* Complete capability studies for process control and generate subsequent production documentation ensuring that all activities are completed and documented in accordance with new product development procedures.
* Complete process qualification (IQ/OQ/PQ) of multi-axis CNC manufacturing processes and any other processes as required by the project.
* Review and approval of validation documentation.
* Provide engineering support for new product and process introductions.
* Provide training to manufacturing team members and other Engineers.
* Ensure adherence to GMP and safety procedures.
Qualifications:
* B.S in Mechanical / Manufacturing / Precision Engineering or related engineering discipline with 2 or more years' industry experience.
* Passion for CNC machining and high precision manufacturing processes.
* Hands-on machining experience with multi-axis CNC machining (grinding / mill-turn / sliding head etc.) would be advantageous.
* Knowledge of CAD/CAM and CNC coding would be advantageous.
* Must be able to read and interpret complex engineering drawings and have the ability to understand geometrical dimensioning and tolerancing.
* Excellent interpersonal skills - must be able to express ideas to the wider cross-functional team, collaborate with cross-functional teams to achieve project goals, and be open-minded with the ability to recognise good ideas.
* Innovative thinker - should be able to envisage new and better ways of doing things.
* Continuous improvement and lean 6 sigma mindset advantageous.
* Experience in executing complex problem-solving techniques related to manufacturing/design technical issues.
* Good instincts and sound judgement for mechanical and structural design.
* Excellent analytical skills, ability to accurately plan, organise, and implement concurrent tasks.
* Good knowledge of manufacturing processes, inspection equipment, materials, and process design.
* Experience in an FDA regulated or regulated industry beneficial.
* Excellent attention to detail.
Requirements:
This role requires a strong background in mechanical engineering, CNC machining, and high precision manufacturing processes. Experience in working with complex engineering drawings, CAD/CAM software, and CNC coding is highly desirable. Additionally, excellent communication and collaboration skills are necessary to work effectively with cross-functional teams.