Career Opportunities
At BeamLab, we strive to provide inspiring, empowering and rewarding job opportunities for talented individuals who share our desire to battle health disparities across the globe. We welcome all qualified persons who strive to expand the boundaries of medical technology to join our team. We encourage our employees to be creative, to lead and to challenge the limitations of the medical technology industry. If you aspire to work with an adept team and innovative technology that could change lives, a career at BeamLab might be suitable for you.
Available Positions
Position: Technical Writer for Medical Device Development & Certification
- Job Description: The Technical Writer will be responsible for authoring technical documents as required by the relevant regulations and standards to receive CE Mark and FDA approvals for a new robotic patient positioning system and a novel radiosurgery system. The position will also be responsible for communicating with the core development team to acquire the necessary information and data to support the documentation development; therefore, excellent communication skills are essential. The position will also be responsible for providing project-specific support, including technical analysis and review of supplier documentation as required. The position will report to the CTO.
- Responsibilities: Author and maintain project-specific documents according to the regulations and standards for medical development and certification. These include, but are not limited to Design & Development Plans, Design Input/Design Trace Matrix, Software Development Plans, Risk Management Plans, Specifications, Test Methods, System Diagrams, Interaction Diagrams, Data Flows, Logical & Physical Architecture Diagrams, Design Verification Summary Reports, and Design Transfer documentation. Review the company’s and supplier’s documentation and provide expert judgment on how to most efficiently support the Design History File (DHFs). Collaborate with suppliers and Client functions to ensure appropriate documents are transferred or referenced appropriately in order to build compliant DHFs. Responsible for assessments of proposed changes related to project documentation. Author relevant technical sections of regulatory briefing books, submissions (CE, 510K), and other technical documentation as required. Participate in design review teams and in technical assessments.
- Qualifications & Requirements: BS, MS, or Ph.D. in Mechanical Engineering, Electrical Engineering, Biomedical Engineering, Computer Science, Physics, or related discipline. Excellent communication (written and verbal) skills are essential. At least ten years of hands-on experience in writing technical documents for the development of electromechanical devices. Experience with quality system documentation authoring is required. Working knowledge of worldwide medical device regulations, including 21 CFR 820, and ISO 13485, and how they apply to software and hardware development. Direct experience with IEC 62304, IEC 60601, and ISO 14971 is required.
- Job Types: Full-time: 8-hour shift Monday to Friday, or Contractor. Remote or on-site.
If any of our available positions call out to you, please send your resume and cover letter to Donald Medlin at dmedlin@medbeamlabs.com