Job Detail

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

Senior Manufacturing Engineer

Job ID: JOB-11300
Senior Manufacturing Engineer

Our client who develops and manufactures implantable medical devices, is an outsource partner to many of the leading, global medical device companies,  are recruiting for a Senior ME. The position requires a proven candidate with a background in leading high-value manufacturing engineering support within a GMP-regulated medical devices industry. 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. 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. He/She 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.

Duties and Responsibilities

  • Provide leadership to the manufacturing engineering function on-site in providing high-value support to Aran Biomedical’s 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.
  • A key input to PFMEA-generation workshops with the 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.

Key Requirements for the role

  • The 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 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 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 further information on this role please contact Deirdre Finnerty on 086 3073779/ deirdre@hero.ie

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Deirdre Finnerty

JOB-11300

Senior Manufacturing 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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