Description:
Our client, a global leader in neurovascular care is seeking to hire a Manufacturing Engineer on an initial 12-month contract for their offices in Galway. A Bachelor of Engineering degree and 3+ years’ experience is a must for this role.
Responsibilities
- Initially support, and eventually lead Cost Improvement (CI) and Life Cycle Management (LCM) projects by working closely with the project core team (Manufacturing, Quality, R&D, Regulatory etc.) and extended team members to develop and manage project plans and budgets, leads project team meetings, and generates meeting minutes with clear actions.
- Periodic reporting on project status to senior leadership.
- With guidance, works on proposals and cost estimates of project/process related costs or cost improvements.
- Facilitates experiments and capability studies, designs, and procures process tools and develops process specifications.
- Evaluates and implements equipment, materials, and process performance requirements for optimized, balanced line performance and with the intent of achieving continuous improvement of present methods.
- Performs vendor and production evaluation to ensure adequate capability to produce quality products in required quantities at an effective cost.
- Applies broad scientific and engineering knowledge to the required design changes of medical device products, including associated validations.
- Exercise’s judgment, with guidance, within generally defined practices and policies in selecting methods and techniques for obtaining solutions.
- Ensures project deliverables are compliant to applicable standards, regulations, and procedures
- Generates written protocols and reports to support assigned projects.
- Maintains accurate documentation of concepts, designs, drawings, processes, test methods, data analysis and conclusions or rationales.
Requirements
- A minimum of Bachelor of Engineering degree is required.
- A minimum of 3 years of job-related experience is required.
- Experience of working on a project team is required.
- Project management skills are preferred.
- Certification to a Project Management authority i.e., PMP, APM etc. is advantageous but not required.
- Medical device industry experience is preferred.
- Familiarity with ISO 13485 Design Control, Design Verification and Validation, and manufacturing process qualifications (IQ, OQ, PQ) as related to medical devices is preferred.
- Experience in managing technical relationships with external suppliers and external manufacturers (EMs) is preferred.
- Knowledge of financial accounting and analysis methods to assess project values and capital requirements is preferred.