Process Development Engineer

HERO

Job Detail

Location Limerick Ireland
Salary Negotiable
Posted
Role Type Permanent
Contact Shauna Brady
email Recruit@hero.ie

Process Development Engineer

Apply Now

Job ID: JOB-13078

Process Development Engineer

The primary purpose of this position is to focus on the development of processes required to manufacture device designs which are developed by Research & Development in our clients premises.

Reporting to: Senior Process Development Engineer 

Responsibilities:

  • Collaborate in a team of engineers focused on identification, development, and implementation of new processes (within our clients facilities or with third parties) required for the manufacture of device designs which are developed by R&D departments.
  • Process validation owner for new processes associated with NPI’s and or process development.
  • Ensure that a risk based approach is applied during the development implementation and validation of all processes both within our clients premises and with third party suppliers.
  • Ensuring that the principle of Design for Manufacture is central to the R&D process and the devices developed within R&D.
  • Where appropriate apply Lean Manufacturing principles to the design and implementation of new processes.
  • Responsible for process documentation (PFMEA’s, Production Instructions, Drawings etc.) associated with NPI’s and or process development. Collaborate with other R&D Teams to ensure the effective completion of all activities associated with an R&D Engineering project / objective.
  • Work closely to build effective relationships with other functions in particular Operations, Quality and Regulatory teams. Supplier selection, process development and validation. Support Regulatory Affairs as required with engineering input for process related submissions and renewals prior to and post initial release of devices to market. Ensuring the effective transfer of products from other entities.
  • Provide engineering input and support to those responsible for Supplier instigated changes. Liaise with R&D and Process Development teams to ensure the effective transfer of new devices from Development to Sustaining cycles.
  • Responsible for process engineering layout plans and implementation in relation to new processes and production lines.
  • Provide engineering input and support for the investigation and resolution of Non Conformances associated with devices post release to market. Support the post market surveillance of devices in terms of complaint investigation and risk analysis.
  • Other General Responsibilities: Uphold the compliance culture and ensure that compliance requirements are always met.
  • Liaise with other manufacturing facilities. Support other cross functional groups to achieve Company goals. Benchmark systems and processes against best industry practice and modify and develop accordingly to further improve operations efficiencies.
  • Ensure that Code of Conduct is considered in all business matters carried out.

Qualifications:

  • Formal production/engineering qualification and/or relevant experience in the area of NPI and or process development.
  • Ideally candidates should have a minimum of 2 years process development experience in a Medical Device company Project management capability Strong interpersonal skills and the ability to communicate at all levels of the organization.
  • Strong knowledge of medical device quality standards ISO13485/FDA practices and GMP or similar regulated industry standards.
  • Proven problem-solving skills. Good computer skills including knowledge of Microsoft® Office.
  • Excellent organizational and team building skills. High self-motivation. Willingness and availability to travel on company business.

For further information on this role in please contact on Shauna Brady on 086-441 0614 or recruit@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.

 

Data can only be transferred outside of the EEA on the basis of standards contractual clauses, to a country for whom an adequacy decision has been given by the European Commission or where the express permission of the data subject has been given.  You have supplied us with your personal data in the process of applying for a position.  Our client company may have personnel outside of the EEA who will review your data.  We will apply the appropriate criteria in respect of the data transfer depending on the location of those personnel.

For further information on this role in please contact on Shauna Brady on 086-441 0614 or recruit@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.

Shauna Brady

JOB-13078

Apply Now

Process Development Engineer

Shauna Brady

Role Type Permanent
Contact Shauna Brady
email Recruit@hero.ie
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