Senior Process Development Engineer

HERO

Job Detail

Location Galway
Salary Negotiable
Posted
Role Type Permanent
Contact Deirdre Finnerty
email deirdre@hero.ie

Senior Process Development Engineer

Apply Now

Job ID: JOB-12204

Senior Process Development Engineer

Our client, a medical device company located in County Galway is recruiting for a Senior PD Engineer to join their team. The position requires a proven candidate with a background in leading high value Process Development as part of New Product Introduction (NPI) within a GMP-regulated medical devices industry.

Candidates must have a minimum of 5 years of experience in leading new products introduced into a commercial state, leading continuous improvement and compliance support within an ISO-8 (or higher) clean environment. Due to exciting growth on a number of new product/ technology introductions in 2022, the successful candidate will liaise heavily with cross functional teams encompassing R&D, manufacturing engineering, maintenance, EH&S, quality engineering, and supply-chain functions. He/she will hold a leadership role in maintaining high quality/ performance/ safety standards on all assigned implant-products platforms. Reporting to the Engineering Manager, the position will be challenging, involve exposure to the latest company implant product-designs and will require an ability to work autonomously.

Key Responsibilities:

  • Provide leadership to the engineering function on-site for product and technology transfer from R&D to manufacturing operations.
  • Operate as direct support to the site’s Engineering Manager as a key decision maker in providing technical direction to all manufacturing operations staff through daily/weekly production and project review meetings.
  • Lead medium-to-large scale cross-functional project teams and projects to successful outcomes.
  • Display excellent organisational and project management expertise in addressing short-term and longer-term production floor issues pertaining to quality, cost and delivery metrics.
  • Manage, coach and mentor Process Development engineering and technician resources to foster efficient and cohesive department performance.
  • Deploy the principles of KPI analysis, lean and six sigma in identifying and implementing the optimum areas for improvement as part of all NPI into a commercial state.
  • Oversee the execution of all Test Method Validations and process qualification.
  • Key input to PFMEA-generation workshops with Quality Assurance department.
  • Update and review manufacturing, quality and engineering-related documentation as required – driving and reviewing Engineering
  • Change Notice (ECN) proposals.
  • Foster a multi-departmental approach to problem-solving driving root cause-analysis reviews.
  • There will be a strong linkage with the Quality Assurance department in supporting the Regulatory and Compliance requirements of an ISO13485 organisation. This will encompass NCR and CAPA ownership and resolution.

Key Requirements for the Role:

  • The successful candidate must have a strong record of accomplishment of project completion within a medical device environment.
  • This role is a leadership role within the Process Development engineering group and will involve the production support of multinational-customer products – and as such, experience is essential.
  • A Bachelor’s degree in manufacturing engineering, biomedical engineering, quality engineering, or related field and 5 years minimum experience is required.
  • People and Project management experience are essential.
  • Strong familiarity with FDA GMP/QSR; ISO 13485, and medical standards is essential.
  • Solid knowledge of PFMEA development, IQ/OQ/PQ validation is essential.
  • The candidate must be highly motivated and passionate about meeting production targets with excellent time-management, presentation, communication skills, technical writing skills, and organizational skills with the ability to work independently or as the leader of a team.
  • Possess strong leadership and analytical skills with a hands-on approach.

For further information on this Senior PD Engineer role in Galway please contact Deirdre Finnerty on 086 3073779/ deirdre@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 you data.  We will apply the appropriate criteria in respect of the data transfer depending on the location of those personnel.

 

Deirdre Finnerty

JOB-12204

Apply Now

Senior Process Development Engineer

Deirdre Finnerty

Role Type Permanent
Contact Deirdre Finnerty
email deirdre@hero.ie
mobile +353 86 307 37 79
linkedIn profile click here

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