R&D Engineer II
4 weeks ago
The R&D Engineer II will be responsible for supporting medical diagnostic instrument related development and testing activities, including hardware, firmware, and software development and testing. The candidate will work within R&D Engineering, participate in cross-functional project core teams, and interact with various departments within the organization.
The R&D Engineer II will also be responsible for identifying challenges in R&D data backup processes, developing solutions, and presenting them to the core team. Additionally, the candidate will support other teams at our Meridian global sister R&D sites and businesses in line with business needs.
Key Responsibilities- Support other MBI R&D sites and business units
- Prepare technical documents with RA team for 510(k) submissions
- Lead instrument and software related validation and verification projects
- Design, develop, and improve R&D instrument related workflows and SOPs
- Manage instrument and software update control process for Curian, Curian Flex, and M10 platforms
- Lead the engineering part of one or multiple New Product Development projects
- Participate at the core team level and support tasks such as:
- DHF document review and management
- Technical troubleshooting
- Risk analysis
- Technical documents for regulatory submissions
- Change control
- Instrument and software release management
- Proficiency in programming languages (particularly C, C++, and C#)
- Comprehensive knowledge of engineering principles and concepts (particularly Electronics and Embedded Systems)
- Experience working within a QSR, IEC 62304, and/or ISO 13485 environment
- Experience working on medical device verification and validation activities
- Strong interpersonal and problem-solving skills with ability to interact effectively with all levels of the organization both internally and externally
- Ability to work on complex development tasks - including new development, new features to existing instrument, and maintenance
- Ability to prioritize multiple tasks from various internal and external stakeholders
- Ability to translate business unit goals into executable plans understanding technical risks, mitigations and alternatives
- Capacity to work from detailed specifications or from defect reports
- Ability to clearly communicate ideas and solutions to other team members
- Ability to independently work with external vendors and/or collaborators from sister sites for technical communications
- Can work independently with minimal supervision; self-teaching ability is a plus
- Must possess strong organizational skills with attention to detail to prioritize and balance workloads while meeting strict critical deadlines and performing under pressure in a fast-paced environment
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