
Medical Device R&D Engineer
1 day ago
We are seeking a talented individual to join our team in the role of Medical Device R&D Engineer. As a member of our team, you will be responsible for driving innovation and excellence in the development of medical devices.
The ideal candidate will have a strong background in engineering, with a focus on quality, mechanical, electrical, and software systems. They will possess excellent communication skills, both written and verbal, and be able to effectively collaborate with cross-functional teams.
Responsibilities:
- Create and implement comprehensive procedures, work instructions, flowcharts, forms, templates, checklists, worksheets, and other product and process related documentation to ensure process compliance.
- Develop and maintain a deep understanding of best practices and industry regulations, including ISO 13485, 60601, and 14971.
- Act as a resource for colleagues with less experience and mentor engineers/designers.
- Lead small projects with moderate risks and resource requirements, and provide budget, cost, and schedule input.
- Support verification testing, transition to production, and field issue resolution, and consistently deliver high-quality software at a sustainable speed.
- Collaborate with system engineering groups and adopt good practices, and develop strategies for knowledge build-up and life cycle management products.
Requirements:
- Minimum of Bachelor's Degree in STEM (Electrical & Electronics Engineering preferred).
- Ability to effectively communicate technical information in English (both written and oral).
- Strong problem-solving skills, analytical thinking, and ability to handle complex tasks or problems that impact site compliance.
- Experience in establishing design quality control, assurance, regulatory affairs teams, and competence development from scratch within a regulated industry.
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