MDR - Sr R/D Engineer
4620 North Beach Street Haltom City, TX 76137 US
HM's Top Needs:
- Design principles / design change control experience
- Quality system experience in a regulated industry (medical devices, pharmaceuticals)
- Design / Risk flow down; Risk management experience
Education Required: Bachelor’s degree in a technically related field required
Years’ Experience Required: Minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience
Responsibilities may include the following and other duties may be assigned.
This position has the responsibility and authority to under limited supervision, incumbent applies engineering principles to provide engineering support for released product engineering. The focus of this engineer will be on EU MDR design compliance for legacy product compliance before the transition deadline. Activities may include optimization of design, existing product modifications, and/or process design, development and optimization and performance evaluation. Responsibilities include testing and documentation of products and processes. Provides assistance to project teams by developing test protocols, technical methods, and test reports. Coordinates and plans testing and documentation requirements. Provides engineering and technical support to other functional areas of the company as required.
SPECIALIST CAREER STREAM: Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects from design to implementation while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education (typically University).
Autonomy: Established and productive individual contributor. Works independently with general supervision on larger, moderately complex projects / assignments.
Organizational Impact: Sets objectives for own job area to meet the objectives of projects and assignments. Contributes to the completion of project milestones. May have some involvement in cross functional assignments.
Innovation and Complexity: Problems and issues faced are general, and may require understanding of broader set of issues or other job areas but typically are not complex. Makes adjustments or recommends enhancements in systems and processes to solve problems or improve effectiveness of job area.
Communication and Influence: Communicates primarily and frequently with internal contacts. External interactions are less complex or problem solving in nature. Contacts others to share information, status, needs and issues in order to inform, gain input, and support decision making.
Required Knowledge and Experience: Requires practical knowledge and demonstrated competence within job area typically obtained through advanced education combined with experience. Requires a University Degree and minimum of 4 years of relevant experience, or advanced degree with 2 years of experience.
Nice to Have: EU MDR experience or other regulatory design compliance related activities
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