Connecting to LinkedIn...

Vacancy Details

Engineering & Technical

Post Market R&D Engineer - Galway

Contract Type: Permanent
Sector:
Location: Galway
Date: 26/11/2019
Job Reference: 106310
Contact Name: Orla McAndrew
Contact Email: connect@hero.ie

Job Description

Post Market R&D Engineer

Our client, a medical device company in Galway are currently looking to recruit a Post Market R&D Engineer for their site.

Job Description

The commercial product R&D engineer will support post-commercial R&D activities for the aortic endovascular business. This engineering position requires solid technical and leadership skills to maintain the rigor and diligence necessary for commercial product support. The engineer will apply technical principles, theories, and new concepts to collaboratively solve difficult technical problems and assess impact of proposed changes on form, fit and function of designs. The engineer will work under the limited direction of the post market lead but will have significant latitude in determining methods of solving problems, design and construction of analysis associated with commercial product testing.

Responsibilities
• Technical review and approval of change orders initiated by internal manufacturing sites.
• Review and approval of post market surveillance reports, and any subsequent updates for risk management documentation.
• Root cause analysis related to commercial issues, including technical support of non-conforming material reports and product impact assessments.
• Contributor or owner of corrective actions / preventative actions (CAPAs).
• Support of rest of world (ROW) regulatory filings and regulatory recertification.
• Point of contact for technical questions from sales, marketing and clinical organizations for specification and design questions.
• Identify and correct issues missed by PDP teams to ensure technical excellence and compliance of commercial products.

The post-market R&D engineer is responsible for support and execution of the following in collaboration with the R&D post market engineering team and lead. The commercial product engineer may be individually accountable for these actions.
• Act as point person for technical questions from the field on commercial product.
• Accountable for liaising with quality, to identify and complete post-market R&D work committed to during PDP phase.
• Engage with commercial manufacturing sites to understand planned change initiatives that will require R&D support, and often have regulatory implications. Negotiate with manufacturing sites regarding scope of work and timelines as necessary.
• Evaluate the workload associated with R&D approval of changes and develop a strategy to resource change approval such that impact to R&D resources is minimized.
• Act as subject matter expert in the evaluation and resolution of non-conforming material reports.
• Act as subject matter expert in the evaluation and resolution of issues resulting in the completion of product impact assessments
• Support or identify a qualified Engineer to support ROW regulatory filings, following Western Europe and US approval. Complete R&D activities necessary for periodic regulatory recertification (compliance to ISO standards).

Qualifications/ Experience
  • Bachelors degree required.
  • Minimum of 2 years of experience, or advanced degree with 0 years of experience required.
  • Degree in engineering (Mechanical, Materials, or Biomedical) – Advanced technical degree is preferred.
  • Minimum of 2 years of experience in medical device product development.
  • Experience with complex catheter based delivery systems.
  • Experience with implantable cardiovascular devices.
  • Experience in commercial manufacturing and production of medical devices.
  • Prior experience in medical device quality systems is required.
  • Experience in engaging with regulatory bodies, through regulatory filings and audit/inspection support. Comprehensive knowledge of ISO and FDA requirements and guidance.
  • Proficiency in SolidWorks.
  • Knowledge of statistical analysis software and applications.
  • Excellent communications skills (written and verbal).
  • Ability to work in a team.
  • Self-starter and driver – able to execute effectively and work efficiently.
  • Proficient in mechanical engineering fundamentals and uses of good engineering judgement.

    Travel Expectations: About 10% of the time
For further information on this in please contact Orla on 086 0468858 / connect@hero.ie

Check out all our open jobs on our HERO Recruitment website –https://www.hero.ie
Please Note: Under its obligation under the Data Protection legislation, HERO Recruitment will not forward your details to any company without your prior approval.


Clients we are proud to work with

W1siziisijiwmtyvmduvmdgvmtivmtkvmdevndq5l2fiynkucg5nil0swyjwiiwidgh1bwiilciyntb4mtuwxhuwmdnlil1d
W1siziisijiwmtyvmduvmdgvmtivmtkvntuvnze4l2fszxjllnbuzyjdlfsiccisinrodw1iiiwimjuwede1mfx1mdazzsjdxq
W1siziisijiwmtyvmduvmdgvmtivmjavmtevmtewl2fsa2vybwvzlnbuzyjdlfsiccisinrodw1iiiwimjuwede1mfx1mdazzsjdxq
W1siziisijiwmtyvmduvmdgvmtivmjavndavmje4l2jvc3rvbi5wbmcixsxbinailcj0ahvtyiisiji1mhgxntbcdtawm2uixv0
W1siziisijiwmtyvmduvmdgvmtivmjavntivotayl2nhbwj1cy5wbmcixsxbinailcj0ahvtyiisiji1mhgxntbcdtawm2uixv0
W1siziisijiwmtyvmduvmdgvmtivmjevmdcvmze0l2nlbgvzdgljys5wbmcixsxbinailcj0ahvtyiisiji1mhgxntbcdtawm2uixv0
W1siziisijiwmtyvmduvmdgvmtivmjevmtkvnjcxl2noywvsbguucg5nil0swyjwiiwidgh1bwiilciyntb4mtuwxhuwmdnlil1d
W1siziisijiwmtyvmduvmdgvmtivmjevmzqvote3l2nvy2fjb2xhlnbuzyjdlfsiccisinrodw1iiiwimjuwede1mfx1mdazzsjdxq
W1siziisijiwmtyvmduvmdgvmtivmjevndgvnzm1l2nyzwdhbmeucg5nil0swyjwiiwidgh1bwiilciyntb4mtuwxhuwmdnlil1d
W1siziisijiwmtyvmduvmdgvmtivmjivmdmvoti1l2dvb2rtyw4ucg5nil0swyjwiiwidgh1bwiilciyntb4mtuwxhuwmdnlil1d
W1siziisijiwmtyvmduvmdgvmtivmjivmtgvodewl2phbmrqlnbuzyjdlfsiccisinrodw1iiiwimjuwede1mfx1mdazzsjdxq
W1siziisijiwmtyvmduvmdgvmtivmjivmzivmtcwl0pmtc5wbmcixsxbinailcj0ahvtyiisiji1mhgxntbcdtawm2uixv0
W1siziisijiwmtyvmduvmdgvmtivmjivndcvnde3l2xpbgx5lnbuzyjdlfsiccisinrodw1iiiwimjuwede1mfx1mdazzsjdxq
W1siziisijiwmtyvmduvmdgvmtivmjivntkvnjeyl21hcmluzs5wbmcixsxbinailcj0ahvtyiisiji1mhgxntbcdtawm2uixv0
W1siziisijiwmtyvmduvmdgvmtivmjmvmtcvntqzl21lzhryb25pyy5wbmcixsxbinailcj0ahvtyiisiji1mhgxntbcdtawm2uixv0
W1siziisijiwmtyvmduvmdgvmtivmjmvmzavote4l21lcml0lnbuzyjdlfsiccisinrodw1iiiwimjuwede1mfx1mdazzsjdxq
W1siziisijiwmtyvmduvmdgvmtivmjmvndqvodexl211c2dyyxzllnbuzyjdlfsiccisinrodw1iiiwimjuwede1mfx1mdazzsjdxq
W1siziisijiwmtyvmduvmdgvmtivmjqvmdavmja5l3blbm4ucg5nil0swyjwiiwidgh1bwiilciyntb4mtuwxhuwmdnlil1d
W1siziisijiwmtyvmduvmdgvmtivmjqvmtivnjg5l3bpdm90lnbuzyjdlfsiccisinrodw1iiiwimjuwede1mfx1mdazzsjdxq
W1siziisijiwmtyvmduvmdgvmtivmjqvmjyvmzuxl3byb3h5lnbuzyjdlfsiccisinrodw1iiiwimjuwede1mfx1mdazzsjdxq
W1siziisijiwmtyvmduvmdgvmtivmjqvmzgvmtm0l3j1c2fslnbuzyjdlfsiccisinrodw1iiiwimjuwede1mfx1mdazzsjdxq
W1siziisijiwmtyvmduvmdgvmtivmjqvntmvoty1l3nhbm1pbmeucg5nil0swyjwiiwidgh1bwiilciyntb4mtuwxhuwmdnlil1d
W1siziisijiwmtyvmduvmdgvmtivmjuvmdyvnza4l3n0zxjpcgfrlnbuzyjdlfsiccisinrodw1iiiwimjuwede1mfx1mdazzsjdxq
W1siziisijiwmtyvmduvmdgvmtivmjuvmjmvmjgwl3n0cnlrzxiucg5nil0swyjwiiwidgh1bwiilciyntb4mtuwxhuwmdnlil1d
W1siziisijiwmtyvmduvmdgvmtivmjuvndqvota2l3rozxjtb2xpbmcucg5nil0swyjwiiwidgh1bwiilciyntb4mtuwxhuwmdnlil1d
W1siziisijiwmtyvmtivmdyvmtivntgvmjcvnze0l3ntdc5wbmcixsxbinailcj0ahvtyiisiji1mhgxntbcdtawm2uixv0
More

“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”.

Moira Faherty,
Human Resources Manager
Chanelle Group

“My very first impression was that I was dealing with a recruitment company who were extremely professional, supportive and knowledgeable of the role for which I was applying. Not only were the responsibilities of the role explained to me in great detail, but they also went to great lengths to really understand the depth of my technical, managerial and leadership experience and capabilities. What impressed me the most was their personal touch in building a strong relationship with me as a candidate and in maintaining regular contact with me on the status of the role throughout the application process”.

Adrian Rice,
Engineering Manager 
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”. 

Tom Horkan,
Asst. HR Manger
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"

Fiachra Collins
Computer Vision Algorithm Team Manager
Valeo

“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”.   

Lorraine McDonnell,
Senior Talent Acquisition Specialist
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”.

Christine Power,
VP of Human Resources
Pivot

“HERO recruitment is an extension to our talent acquisition team. From hiring strategy meeting to the induction of the right talent, the HERO recruitment team provide an exemplary service. They are knowledgeable about our business needs, responsive and thorough. A true talent acquisition partner”. 


Orla Keady-Giblin,
Human Resources Manager
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

Nikhil Pradeepkumar
Optical Engineer
Valeo Vision Systems
More

“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”.

Moira Faherty,
Human Resources Manager
Chanelle Group

“My very first impression was that I was dealing with a recruitment company who were extremely professional, supportive and knowledgeable of the role for which I was applying. Not only were the responsibilities of the role explained to me in great detail, but they also went to great lengths to really understand the depth of my technical, managerial and leadership experience and capabilities. What impressed me the most was their personal touch in building a strong relationship with me as a candidate and in maintaining regular contact with me on the status of the role throughout the application process”.

Adrian Rice,
Engineering Manager 
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”. 

Tom Horkan,
Asst. HR Manger
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"

Fiachra Collins
Computer Vision Algorithm Team Manager
Valeo

“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”.   

Lorraine McDonnell,
Senior Talent Acquisition Specialist
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”.

Christine Power,
VP of Human Resources
Pivot

“HERO recruitment is an extension to our talent acquisition team. From hiring strategy meeting to the induction of the right talent, the HERO recruitment team provide an exemplary service. They are knowledgeable about our business needs, responsive and thorough. A true talent acquisition partner”. 


Orla Keady-Giblin,
Human Resources Manager
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

Nikhil Pradeepkumar
Optical Engineer
Valeo Vision Systems
More

Clients we are proud to work with

W1siziisijiwmtyvmduvmdgvmtivmtkvmdevndq5l2fiynkucg5nil0swyjwiiwidgh1bwiilciyntb4mtuwxhuwmdnlil1d
W1siziisijiwmtyvmduvmdgvmtivmtkvntuvnze4l2fszxjllnbuzyjdlfsiccisinrodw1iiiwimjuwede1mfx1mdazzsjdxq
W1siziisijiwmtyvmduvmdgvmtivmjavmtevmtewl2fsa2vybwvzlnbuzyjdlfsiccisinrodw1iiiwimjuwede1mfx1mdazzsjdxq
W1siziisijiwmtyvmduvmdgvmtivmjavndavmje4l2jvc3rvbi5wbmcixsxbinailcj0ahvtyiisiji1mhgxntbcdtawm2uixv0
W1siziisijiwmtyvmduvmdgvmtivmjavntivotayl2nhbwj1cy5wbmcixsxbinailcj0ahvtyiisiji1mhgxntbcdtawm2uixv0
W1siziisijiwmtyvmduvmdgvmtivmjevmdcvmze0l2nlbgvzdgljys5wbmcixsxbinailcj0ahvtyiisiji1mhgxntbcdtawm2uixv0
W1siziisijiwmtyvmduvmdgvmtivmjevmtkvnjcxl2noywvsbguucg5nil0swyjwiiwidgh1bwiilciyntb4mtuwxhuwmdnlil1d
W1siziisijiwmtyvmduvmdgvmtivmjevmzqvote3l2nvy2fjb2xhlnbuzyjdlfsiccisinrodw1iiiwimjuwede1mfx1mdazzsjdxq
W1siziisijiwmtyvmduvmdgvmtivmjevndgvnzm1l2nyzwdhbmeucg5nil0swyjwiiwidgh1bwiilciyntb4mtuwxhuwmdnlil1d
W1siziisijiwmtyvmduvmdgvmtivmjivmdmvoti1l2dvb2rtyw4ucg5nil0swyjwiiwidgh1bwiilciyntb4mtuwxhuwmdnlil1d
W1siziisijiwmtyvmduvmdgvmtivmjivmtgvodewl2phbmrqlnbuzyjdlfsiccisinrodw1iiiwimjuwede1mfx1mdazzsjdxq
W1siziisijiwmtyvmduvmdgvmtivmjivmzivmtcwl0pmtc5wbmcixsxbinailcj0ahvtyiisiji1mhgxntbcdtawm2uixv0
W1siziisijiwmtyvmduvmdgvmtivmjivndcvnde3l2xpbgx5lnbuzyjdlfsiccisinrodw1iiiwimjuwede1mfx1mdazzsjdxq
W1siziisijiwmtyvmduvmdgvmtivmjivntkvnjeyl21hcmluzs5wbmcixsxbinailcj0ahvtyiisiji1mhgxntbcdtawm2uixv0
W1siziisijiwmtyvmduvmdgvmtivmjmvmtcvntqzl21lzhryb25pyy5wbmcixsxbinailcj0ahvtyiisiji1mhgxntbcdtawm2uixv0
W1siziisijiwmtyvmduvmdgvmtivmjmvmzavote4l21lcml0lnbuzyjdlfsiccisinrodw1iiiwimjuwede1mfx1mdazzsjdxq
W1siziisijiwmtyvmduvmdgvmtivmjmvndqvodexl211c2dyyxzllnbuzyjdlfsiccisinrodw1iiiwimjuwede1mfx1mdazzsjdxq
W1siziisijiwmtyvmduvmdgvmtivmjqvmdavmja5l3blbm4ucg5nil0swyjwiiwidgh1bwiilciyntb4mtuwxhuwmdnlil1d
W1siziisijiwmtyvmduvmdgvmtivmjqvmtivnjg5l3bpdm90lnbuzyjdlfsiccisinrodw1iiiwimjuwede1mfx1mdazzsjdxq
W1siziisijiwmtyvmduvmdgvmtivmjqvmjyvmzuxl3byb3h5lnbuzyjdlfsiccisinrodw1iiiwimjuwede1mfx1mdazzsjdxq
W1siziisijiwmtyvmduvmdgvmtivmjqvmzgvmtm0l3j1c2fslnbuzyjdlfsiccisinrodw1iiiwimjuwede1mfx1mdazzsjdxq
W1siziisijiwmtyvmduvmdgvmtivmjqvntmvoty1l3nhbm1pbmeucg5nil0swyjwiiwidgh1bwiilciyntb4mtuwxhuwmdnlil1d
W1siziisijiwmtyvmduvmdgvmtivmjuvmdyvnza4l3n0zxjpcgfrlnbuzyjdlfsiccisinrodw1iiiwimjuwede1mfx1mdazzsjdxq
W1siziisijiwmtyvmduvmdgvmtivmjuvmjmvmjgwl3n0cnlrzxiucg5nil0swyjwiiwidgh1bwiilciyntb4mtuwxhuwmdnlil1d
W1siziisijiwmtyvmduvmdgvmtivmjuvndqvota2l3rozxjtb2xpbmcucg5nil0swyjwiiwidgh1bwiilciyntb4mtuwxhuwmdnlil1d
W1siziisijiwmtyvmtivmdyvmtivntgvmjcvnze0l3ntdc5wbmcixsxbinailcj0ahvtyiisiji1mhgxntbcdtawm2uixv0
More