Radlink is seeking a talented, experienced Biomedical Engineer to manage Regulatory Affairs and Field Engineering. Applicants should have strong knowledge of Quality Systems and leading Medical Device Regulations, including FDA 510k and ISO 13485.

Location: Corporate Headquarters, El Segundo, California

Principal Duties and Responsibilities

• Oversee and manage yearly regulatory audits
• Provide support to hospitals working with Surgeons in the operating room
• Provide field support for products and services for the company’s End Users
• Perform product trials, in coordination with hospitals
• Perform installation of equipment and training for End Users and Distributors

Desired Skillsets

• Hands-on support and service experience in health-care or medical device industry in support of end users
• Excellent telephone skills
• Excellent Trouble Shooting skills
• Knowledgeable in computer and network administration
• Technical competence in using and trouble-shooting medical devices
• Familiarity with medical imaging, DICOM and PACS
• Excellent communications and writing skills
• Willing to Travel

Education and Experience

• Experience working in the medical device industry, imaging equipment or technology
• Four-year college degree in engineering, mathematics, science or similar technically oriented program
• Proficient in use/set-up of computer systems, PACS or other hospital networks