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Senior Manufacturing Engineer

  • Sector: Engineering
  • Contact Email: michelle.mcinerney@collinsmcnicholas.ie
  • Job Ref: 18239

Our Client located in the West of Galway are looking to hire a Senior Manufacturing Engineer for an exciting new project.


About the Role:

The position requires a proven candidate with a background in leading high-value manufacturing engineering support within a GMP-regulated medical devices industry.

 

Due to exciting growth on a number of new product/ technology introductions in 2020, the successful candidate will liaise heavily with cross-functional NPI (new product introduction) teams which can encompass R&D, manufacturing, engineering, maintenance, EH&S, quality-engineering and supply-chain functions.

 

You will hold a leadership role in maintaining high quality/ performance/ safety standards on all assigned implant-products platforms.


Reporting to the Manufacturing Manager, the position will be challenging, involve exposure to the latest Tier1-company implant product-designs and will require an ability to work autonomously.

 

Responsibilities:

  • Provide leadership to the manufacturing engineering function on site in providing high-value support to the manufacturing operations.
  • Operate as a direct support to the site’s Manufacturing Manager and Supervisor and a key voice 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 manufacturing engineering and technician resources to foster efficient and cohesive department performance.
  • Track and monitor employee performance at routine periods providing review feedback and addressing performance concerns.
  • Highlight training and development needs of your team to upper management.
  • Deploy the principles of KPI analysis, lean and six sigma in identifying and implementing the optimum areas for improvement in manufacturing operations.
  • Assist New Product Introduction (NPI) teams with key input into design-for manufacturing and product flow/layout development.
  • Oversee the execution of process qualification related builds.
  • Key input to PFMEA-generation workshops with Quality Assurance department.
  • Direct IQ, OQ, PQ protocol-generation, execution and reporting.
  • 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 where everyone in Aran Biomedical has a voice and is respected for their input in driving root-cause-analysis reviews.
  • Always strive to meet or exceed the expectations of our customers.
  • Manage facility-based EH&S, layout or energy-savings projects as required.
  • Overseeing the management of the maintenance and calibration of critical equipment-systems.
  • 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.
  • Make appropriate decisions on a daily basis, using the Manufacturing Manager and Senior Quality Assurance representatives as needed as the final arbitrators on critical quality-related decisions.
  • Performs other related duties, as assigned.

Requirements:

  • Successful candidate must have a strong track record of project completion within in a medical device environment.
  • This role is a leadership role within the manufacturing engineering group and will involve the production-support of Tier1-multinational-customer products – and as such, experience is essential.
  • A Bachelor’s degree in manufacturing engineering, biomedical engineering, quality engineering, or related field.
  • Candidates must have a minimum of 5 years of experience in leading process, continuous-improvement and compliance support within an ISO-8 (or higher) clean environment.
  • People and Project management experience is essential.
  • Strong familiarity with FDA GMP/QSR; ISO 13485 and medical standards is essential.
  • Experience of transferring products from design into commercial manufacturing is highly desirable.
  • Solid knowledge of PFMEA development, IQ/OQ/PQ validation is essential.
  • 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 a confidential discussion and more information about the role please contact Michelle Mc Inenrey

michelle.mcinerney@collinsmcnicholas.ie

091 706 717