Device Project Lead
Fort Worth Metro Area, Texas
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.
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, updating 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 DRA to prepare 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 & Guidelines. Provide quality documentation and assessments in a timely manner and support follow-up activities as appropriate.
1. 5+ years of medical device experience, developing solutions and leading device programs. Recognized expertise in medical device development.
2. Thorough understanding of medical device development processes.
3. Strong knowledge of relevant SOP, GLP, DQP, GMP and Device regulations/policies.
4. Proven leadership skills.
5. Ability to work in and/or lead interdisciplinary, cross-cultural and multi-organizational teams.
6. Strong communication skills. Strong presentation skills and scientific/technical writing skills.
7. Thorough knowledge of state-of-art instrumentation/equipment for broad field of applications.
8. May require up to 10% travel.
Minimum: BS or equivalent in Engineering, Packaging, or applicable discipline.
Desirable: Advanced degree in applicable engineering discipline (MS, Ph.D. or equivalent).