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Vacancy Details

Engineering & Technical

107262 - Principle Mechanical Engineer - Dublin

Contract Type: Permanent
Location: Dublin
Date: 4/08/2020
Job Reference: 107262
Contact Name: Amanda Reynolds
Contact Email:

Job Description

Principle Mechanical Engineer - Dublin - 107262

My client are searching for a Principle Mechanical Engineer for their Global Medical Device Engineering facility in North Dublin

The Job
  • You will be the Device Development SME and Technical Lead on projects working with both the companies’ portfolio of Legacy Products (which is continually expanding through high profile acquisitions) and NPD.
  • You will lead or participate in the design and development activities of Medical Devices and Combination Products through the design lifecycle from Concept to Commercialization.
  • Working with Key Stakeholders, Senior Management and External Partners to ensure technical requirements are achieved
  • Develop an understanding of Customer Needs and processes to ensure relevant and innovative product development solutions
  • You will define and review Tolerance Stack-Up Analysis for complex mechanical assemblies
  • Drive Root Cause Investigations and provide guidance for FEA Analysis and in Interpreting Results
  • Lead development of appropriate Test Plans to fully characterize devices under development
  • Conduct Design Reviews, FMEA's and Design Verification programs
  • Prepare Technical Files and update documents including product specifications, DHF, drawings, bill of materials, study protocols and supporting design verification activities
  • Manage and assess External Vendors/supplier work and capabilities
  • Support Design Validation and Process Validation programs and lead reviews of any anomalies related to mechanical performance
  • Support Regulatory Submissions and approvals for combination product programs
  • Support Post Approval Regulatory Submission for market expansion and timely technical responses to FDA and healthcare authority inquiries
  • Lead technical aspects of Product Design Change to support quality closures, engaging with medical affairs, supply chain, quality, regulatory, packaging and R&D teams to gather and incorporate inputs for managing marketed product changes
  • Collaborate with R&D, supply chain, and commercial team to Develop Drug Delivery Devices for pipeline products and to provide post launch market support globally
  • You will be working with groups in different geographical regions on a regular basis, e.g., early and late conference calls with circa 10% travel, both domestic and global.

  • Bachelor’s Degree in Mechanical Engineering, Biomedical Engineering, Engineering Technology or other relevant Degree
  • Over 8 Years’ Experience in the Development and Registration (up to commercialization) of Drug Delivery Devices and Medical Devices
  • You will need to be a Strong Communicator to work well with other engineers in a collaborative, fast-paced goal-driven environment
  • Experience of working with GMP, international device regulations and design controls, with practical understanding of key topics: risk management, sterilization, usability

Preferred Experience
  • Thorough and proven knowledge Medical Device Directive (MDD), ISO 13485, FDA Design Controls or similar regulatory environment
  • Strong Materials Background, particularly in plastics and manufacturing of plastic components
  • Extensive experience with Solidworks or other CAD software

For further information on this Principle Mechanical Engineer role in Dublin please contact Amanda Reynolds on 0860468858/

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“I have worked with HERO recruitment (formerly HERO recruitment) for a number of years both within my current and previous position. I have always found HERO recruitment excellent to partner with, the consultants know our industry and cultural fit and can therefore successfully source high calibre candidates to match our open vacancies. I find HERO recruitment very professional to deal with and any candidates I interview who are sourced by HERO always have a positive recruitment experience”.

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Chanelle Group

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Boston Scientific

“HERO have been a key strategic recruiting partner to Hollister ULC over many years. During our continued growth and expansion at our facility in Ballina, Hero have worked closely with us to really understand our recruiting needs, the calibre of talent we are looking for, and the fit for our Hollister culture. HERO have successfully sourced and placed candidates for us into Research and Development, Project / Process Engineering, Supply Chain and key Management roles.  They have a very experienced and professional team, and bring an excellent regional, national and international perspective”. 

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Hollister ULC, Ballina, Co. Mayo

"From the first prompt call-back to the ultimate congratulatory call to inform me of a job offer, Karl was an absolute professional; sound advice, solid research and knowledge of companies, unwavering persistence and friendly encouragement. West is best, so for anyone looking for a technical role, talk to Karl"

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Computer Vision Algorithm Team Manager

“HERO Recruitment continues to be a valued partner in supplying high calibre candidates to all three Boston Scientific sites in Ireland. In particular they have been successful in delivering on specific roles for key project scale-ups. HERO has also provided on-site recruitment presence during increased activity when required and consistently operate in a highly professional and competent manner”.   

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Boston Scientific 

“HERO Recruitment were instrumental in sourcing and delivering key talent to the organisation and enabled us to meet our key deliverables within our start-up phase. They thoroughly understood our culture and constantly over delivered on our expectations. Our partnership with HERO Recruitment has without a doubt been  a professional and collaborative one. HERO exceed themselves in all aspects of recruitment and are an absolute pleasure to work with”.

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Ingersoll Rand – Thermo King

I am extremely grateful to Anne-Marie at HERO Recruitment for helping me land an opportunity in Ireland. She had a great deal of information regarding the job profile, was extremely prompt in arranging an interview and followed it up brilliantly. She was an excellent point of contact between the employer and me during the whole process. She has good knowledge about the process and was well aware of the timelines. I would recommend Anne-Marie, HERO Recruitment to anyone who is looking for opportunities in the country

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