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Job Details

Process Design and Development Lead

Company: Validant
Location: Texas
Reference: Project Manager Texas
Closing Date: 08 Oct 17
Type: Contract
Salary (£): Competitive
Benefits:

Job Summary:

Validant are looking for a Process Engineer/ Jr. Process Lead to drive the process during R&D for a mechanical/electro-mechanical device.

Requirements:

Length:12-14 Months

Role:

Lead and manage all technical project activities and apply technical expertise to facilitate the timely development and delivery of new medical device options. Provide device information in support of a multifunctional project team coordinated by a Project leader.

Drive Client device development, with assistance from external partners, by delivering innovative device concepts and engineering designs which can be verified and validated for patient use.

Duties

1. Actively participate in project teams. Fulfill all related tasks and responsibilities related to own discipline and ensure all own activities are aligned with overall device development process. Coordinate with team members assigned to multiple or complex device development activities. Support all, and leads multiple, activities related to the development of the assigned device projects. Proactively contribute to setting, up-dating and monitoring of team goals.
2. Design, plan, perform and contribute to projects related to more complex scientific/technical engineering activities and design, plan and perform scientific experiments. Develop efficient and robust devices and processes for the manufacture and/or analysis of Medical Devices/Combination Products (e.g. tolerance analysis, risk analysis). Contribute to risk analyses and/or peer review and process challenge meetings. Interact/collaborate with other functions to facilitate transfer of knowledge.
3. Ensure appropriate planning of workload and resources internally and externally, controlling costs and timescale of the respective project tasks.
4. Support preparation of multiple Medical Device/Combination Product pre-registration documents and provides input to answer health authority questions.
5. Drive the evaluation of external device collaborations.
6. Proactively communicate key issues and any other critical topics in a timely manner to the appropriate management level and/or to any other relevant project team member(s).
7. Ensure quality, quantity and timelines in all assigned projects. Work according to appropriate SOPs, GMP, GLP, DQP, QM, HSE, ISEC & Client Guidelines. Provide quality documentation and assessments in a time-ly manner and 

Education:

Minimum: BS or equivalent in Engineering, Packaging, or applicable discipline.
Desirable: Advanced degree in applicable engineering discipline (MS, Ph.D. or equivalent).

Packaging experience would be an advantage.

Apply for this job: Process Design and Development Lead

Contact Information:

Address:  Cork
Unit 4 Emmett House Barrack Square Ballincollig Cork

Rep. Ireland

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