Senior Test Method Engineer – Hybrid
Job ID: JOB-12935
Senior Test Method Engineer – Hybrid role
Within the Design Lab our client focuses on providing Quality support across all aspects of PDP from pre-market product development to post market product surveillance. We participate in the design process to ensure the performance and safety of the coronary devices we develop, is assured, and maintained throughout the product lifecycle.
Responsibilities of the Test Method Engineer:
- Lead Design Assurance team driving continuous improvement in Test Methods with emphasis on improving reliability, reducing variation, and maintaining quality standards.
- Responsible for Design, Development and validation of Equipment, tooling and fixturing that enhances Test Method reliability.
- Lead the modernization of Legacy Test Methods which may include Equipment, Software Programming or Fixturing updates with an emphasis on keeping equivalency to original Test Method validation.
- Collaborate and align all Operating Unit’s and New Product Development projects on Test Method best practices and strategies to ensure consistency in approach.
- Provide technical expertise in Test Method Development and Test Method Validation to New Product Development projects.
- Identify new equipment and technology development initiatives that will drive continuous improvement within the lab.
- Lead and support root cause investigations relating to Test Method & drive problem solving efforts for test issues.
- Perform statistical analysis to assess impact to validation and compare equivalency for products or materials.
- Ensure that corrective measures meet acceptable reliability standards, and that documentation is compliant with requirements.
- You will liaise with NPD projects to facilitate timely completion of Test Method Validation activities.
- Work independently to devise strategies to for improvement and scope, plan and schedule relating projects.
- Lead Team members on execution of project deliverables and co-ordinate all relating activities.
Key Skills & Experience
- We are looking for a qualified person to Minimum of a Bachelor’s degree (Level 8 NFQ) in a relevant technical discipline (e.g., Engineering, Mechatronics, Science) and desirably with a minimum of 4-5 years relevant experience.
- Experience working in the medical device or other regulated industry.
- Experience of equipment design, verification & validation such as URS, Risk Assessment, IQ and EDST (OQ) documents in medical device or other regulated industry are desirable.
- Experience of validating multiple types of Test Methods.
- Be focused on patient and customer, set high standards and instill operational excellence.
- Initiates and Leads Change, Collaborates and Creates Alignment, Drives Accountability and Thinks Critically and Makes Sound Decisions.
- Dynamic team player and can work effectively and proactively across multiple projects
- Ability to lead and mentor up and coming engineers instilling best practices
- Good communicator and fluent in English, with a high level of enthusiasm and motivation.
- Good organizational, presentation and project management skills are desirable.
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