Senior Manufacturing Engineer
This job is with a small medical device company based in a scenic location with highly skilled engineers developing products to save lives. It's a really exciting time to join this company as they are experiencing a period of growth on a number of new product/ technology introductions. You will also hold a leadership role in maintaining high quality/performance/safety standards on all assigned implant-products platforms.
Does this sound like something you would be interested in?
Let me tell you a little bit more about this job...
- You will show excellent organisational and project management expertise in addressing short-term and longer-term production floor issues while adhering to quality, cost and delivery metrics.
- You will be responsible for providing leadership to the manufacturing engineering function on site in providing high-value support to the company's manufacturing operations.
- You will 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.
- As part of this job, you will also manage, coach and mentor manufacturing engineering and technician resources to foster efficient and cohesive department performance.
- Track and monitor your employee's 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.
- Overseeing the management of the maintenance and calibration of critical equipment-systems.
Your Background and Experience:
- 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 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 more information, please contact Emma on 091 455 307.
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