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Vacancy Details

Science Pharmaceutical and Food

Senior R&D Engineer / Medical - Limerick

Contract Type: Permanent
Sector:
Location: Limerick
Date: 7/11/2019
Job Reference: 105702
Contact Name: Bimi Felix
Contact Email: bimi@hero.ie

Job Description

Senior Medical R&D Engineer / Limerick

Our client is looking for a highly talented Senior R&D Engineer to take responsibility for providing their medical design and R&D knowledge to further development efforts on the Research and Development Engineering Team for for the Medication Management Solution (MMS) business unit segment, with specific focus on infusion (volumetric and syringe) pump systems and device remediation. The Senior R&D Engineer will need to demonstrate a good understanding of fundamental R&D medical design engineering principles, procedures and techniques across the spectrum to connect various functional elements related to the development and through life of electronic hardware and software systems.

Job Description
The Senior R&D Engineer will need to demonstrate a good understanding of fundamental R&D medical design engineering principles, procedures and techniques across the spectrum to connect various functional elements related to the development and through life of electronic hardware and software systems and subsystems. The suitable candidate has a background in the medical industry with design engineering and regulatory compliance, product remediation, technical risk analysis, traceability, and documentation approval. The suitable candidate should also be able to analyse customer/user needs to produce detailed requirements specifications and systems architecture for the creation of new or enhancement of existing hardware and software products that may affect multiple systems.

The suitable candidate has a background in the medical industry with design engineering and regulatory compliance experience, as well as a proven background with product remediation, clinical testing, technical risk analysis, traceability, and documentation approval following a formal Quality Management System. The suitable candidate should also be able to analyse user needs to produce detailed requirements specifications and test protocols for new and existing infusion system hardware and software products. Also, the suitable candidate should be effective at collaborating and coordinating technical medical device issues across several global sites and multiple business functions (marketing, operations, PMO, quality, medical affairs, etc.).

Be the Senior R&D Engineer:
  • Demonstrate knowledge of advanced system-level medical device technology and R&D development process through V&V and clinical trials.
  • Demonstrate detailed knowledge of medical product design process.
  • Coordinating and influence product development across multiple disciplines and BD global locations.
  • Serve as a key resource to examine product behavior issues and bring to resolution for existing infusion products.
  • Provide technical support to a wide range of engineering problems pertaining to specific MMS infusion programs and projects.
  • Clearly communicate verbal and written information and ideas through a variety of media to individuals or groups in a manner that engages the audience and helps them understand and retain the message.
  • Assures deep technical understanding of infusion products.
  • Able to drive technical excellence and design decisions throughout the global organization.
  • Identify technical risks early and often; establishes mitigation options, and tracks resolution.
  • Making stakeholders and their needs a primary focus of one’s actions; developing and sustaining productive business relationships on a global front.
  • Setting high goals for personal and group accomplishment; pushing oneself and others to exceed performance goals and standards; strong and independent drive for success.
  • Establishing courses of action and plans for self and others to ensure that work is completed efficiently; successfully encourages others to take responsibility for their work packages.
Be Qualified:
  • Degree qualified (or equivalent) ideally in biomedical, mechatronics, mechanical, electrical, electronics, software or systems engineering.
  • Demonstrable track record in professional work experience with 10+ years’ overall experience in the medical industry.
  • Ability to work in a team or individually with global collaboration.
  • Ability to support Regulatory Affairs with engineering input for design related submissions & resubmissions (510K/Notifications).
  • To be responsible for the completion of risk benefit analysis documentation including documenting background of devices types, use case, harms, treatments, benefits, competitor devices, clinical studies, biocompatibility & materials and literature review.
  • Maintain technical risk management files for existing devices (i.e. dFMEA, Risk Benefit Analysis) and take input from Clinical Evidence Reports (CER).
  • Knowledge of MDR/MDD/AIMD, global medical device/FDA regulations, ISO 14971, ISO 13485, EN/IEC 60601, device remediation, UDI & device traceability, Sterilization, Material Biocompatibility, and Clinical Trials is preferred.
  • Experience working within formal medical QMS processes and system tools (i.e., SAP, Agile PLM, etc.) is preferred.
  • Experience in DFSS (Design for Six Sigma) knowledge and experience is preferred.
  • Experience with formal Requirements Management and document configuration tools is an advantage, and;
  • Strong technical writing skills, producing requirements specifications, risk reports, and test procedures.

For further information on this Senior Medical R&D Engineer role in Limerick please contact Bimi Felix on 086 8395533 / bimi@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

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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”.

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
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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”.

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

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