Our client a company which designs, develops and manufactures medical devices is recruiting for a Senior ME for Galway. 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 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 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.
Key Requirements for the role
- 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 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 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 Senior Engineer role in Galway please contact Deirdre Finnerty on 086 3073779/ firstname.lastname@example.org
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.