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Senior Product Development Engineer

Job Title: Senior Product Development Engineer
Contract Type: Permanent
Location: Galway
Industry:
REF: 85176
Job Published: 6 months ago

Job Description

Senior Product Development Engineer

Our client, an established medical device and manufacturing company in Galway are currently looking to recruit a Senior Product Development Engineer for their site.

Responsibilities
  • Manage product development projects, both internally and on behalf of clients (e.g. project planning, quote/budget, tracking, risk management, reporting, communications etc.) using the 13485 and FDA 21CFR 820.30 guidelines
  • Continuously monitor project performance against resources, timing, budget, risk and results and report variance to contract.
  • Prepare reports/documentation to communicate status and results internally and to customers.
  • Set up project design review agenda and facilitate effective project reviews in accordance with ISO13485 / FDA 21 CFR 820.30.
  • As part of the design team, the candidate will be expected to work closely with, and manage both internal and external specialists to progress projects through to completion.
  • Management of customer communications.
  • Maintain Dept. Processes in line with Industry best practice. Ensure documentation/drawing standards for equipment meet company standards.
  • Initiate proposals for improvement based on customer feedback or based on the identification of opportunities for improvement via new trends/ technologies / processes.
  • Comply with internal and external regulatory requirements by ensuring that documentation such as Product development, manufacturing process and test specifications / procedures are completed and are in compliance.
  • Develop products in Solidworks from inception through to transfer to production.
  • Complete dimensional 2d Quality control drawings for manufacturing.
  • Perform kinematic and engineering mathematical calculations and analysis.
  • Develop and manage Design Verification Test protocols and reports
  • Complete process development activities such as tolerance development to ensure robust function and process capability.
  • Develop validation protocols for tooling and assembly processes and review validation reports for compliance.
  • Complete Risk Management as per ISO requirements
  • Liaise with manufacturing function to ensure manufacturability of products.
  • Complete form, fit, function assessment, tolerance and capability analysis on high cavitation moulded assemblies
  • Analyse data and problem solve using six sigma tools
  • Work within a multidisciplinary team on diverse projects
  • Manage prototyping activity within the project
  • Resolve design, testing and manufacturing issues as they arise.
  • Direct, develop and coach your direct reports - cultivate a strong team ethos - support talent management for direct reports.
  • Participate in PR and Sales support activity as required.

Qualification
  • Degree in relevant engineering discipline. Master's degree an advantage.
  • Level 8 Degree in Engineering Discipline,

Experience
  • 10 years (min 8) direct engineering experience in medical device or other highly regulated manufacturing environment. Product Development experience.
  • Strong Project management skills are essential - managing complex projects from concept through to transfer to production.
  • Track record of external customer management
  • Proficient in Solidworks 3d and 2d - Ability to build complex assemblies.
  • Catheter project experience is an advantage.
  • Capability in kinematic maths and engineering maths is essential
  • Capable of analysing designs via FEAs and simulations
  • Excellent analytical and problem solving skills.
  • Must have an excellent understanding of design for manufacturing of injection tools and assembly processes.
  • Experience in design and development of plastic products for manufacture and assembly and of manufacturing processes, e.g. Injection Moulding, Extrusion, Bonding etc.
  • Fluent in design/development processes and tools (six sigma training) Process development.

Personal Qualities:
  • Results driven and able to deliver.
  • Demonstrates a strong commitment to achieving results in collaboration with key internal and external customers.
  • Excellent oral communication and presentation skills (written, verbal and visuals) for all levels of the organisation and customer base
  • Commercially aware, able to develop effective project, and operational plans.
  • Proven people management skills an advantage.
  • Ability to deal with and manage change. Demonstrate flexibility and ability to adapt to changing requirements.
  • High energy with the adaptability and flexibility to deal with continuous change and innovation.
  • A strong strategic orientation with good day-to-day tactical management and attention to detail.
  • Effectively handle multiple priorities
For further information on this Senior Product Development Engineer role in Galway please contact Deirdre Finnerty on 091730022 / deirdre@hero.ie
Check out all our open jobs on our HERO Recruitment website - www.hero.ie

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