Senior Manufacturing Engineer-12 month contract
In this role, the candidate will lead and execute a portfolio of Life Cycle Management (LCM) projects. Emphasis will be on delivering projects on-time, within budget in a compliant and reliable manner. You will also be accountable for delivering projects which will require building project plans, aligning partners, managing the timeline, budget and driving team accountabilities to deliver the final project objectives. You will also work with functional partners to define/align on the business case and project scope to support project execution; following compliance defined through the companys' procedures.
The Senior Manufacturing Engineer for Life Cycle Management:
- Supports, with guidance, on the execution of Life Cycle Management projects in a cross-functional setting.
- Lead projects by working closely with the project core team (marketing, manufacturing, quality, testing, supply chain etc.) and extended Teams to develop and manage project plans, leads project team meetings and generates meeting minutes.
- With guidance, works on proposals and cost estimates of project/process related costs or cost improvements.
- Supports, with guidance, predetermined long-range goals.
- Maintains product design and process knowledge for assigned products.
- Ensures multi-project coordination of changes for assigned products.
- Applies broad scientific and engineering knowledge to the required design changes of medical device products, including associated validations.
- Works, with guidance, in cross-functional teams (both internal and external) to determine root cause, develop mitigations and corrective and preventative actions for design related issues.
- Exercises judgment, with guidance, within generally defined practices and policies in selecting methods and techniques for obtaining solutions.
- Evaluates, with guidance, products/processes and collaborates with R&D, NPI, Sourcing, QA, MFG and Finance teams to lead projects / initiatives to improve quality, productivity and reduce costs.
- 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.
- With guidance, provides technical support to outside suppliers, vendors, and/or consultants as required, inclusive of supplier visits and identification / implementation of process improvements.
- A minimum of Bachelor’s of Science in Engineering degree is required.
- A minimum of 4 years of job-related experience is required.
- Project management skills are preferred (Microsoft Project, FPX and/or other project management tools).
- 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.
- Knowledge of financial accounting and analysis methods to assess product standard costs, project values, and capital requirements is preferred.
- Experience in managing technical relationships with external suppliers and OEMs is preferred.
- Supplier development skills are preferred
- Strong communication, team building, and cross-functional coordination skills is preferred.
- This position requires up to 10% of travel.
- This position is in Galway, Ireland.
Any applicant will need to have a valid visa (Stamp 4) or an EU passport to apply for this role as there is no visa sponsirship offered with this role.