Senior Medical Device Technical Writer – Regulatory Submissions

ECI; Burlingame (CA); On-site; USD 80,000 - 100,000; Full time

Job summary

ECI in Burlingame, California is seeking a Senior Technical Writer to create and maintain high-quality documentation for medical devices. The role involves developing user manuals, collaborating with teams across engineering and quality, and ensuring compliance with regulatory standards such as FDA and ISO. The ideal candidate should have a Bachelor’s degree in a related field and at least 5 years of relevant experience. ECI offers a welcoming team and is committed to equal opportunity employment.

Qualifications

• 5+ years of experience in technical writing, preferably in medical devices or healthcare.
• Familiarity with document management systems and tools.
• Knowledge of usability engineering and risk management processes.

Responsibilities

• Develop and maintain technical documentation such as User manuals and instructions for use (IFU).
• Ensure documentation complies with regulatory standards such as FDA and ISO.
• Collaborate with cross-functional teams (engineering, quality, regulatory, clinical).
• Translate complex technical and scientific information into clear, user-friendly content.

Skills

Excellent writing, editing, and communication skills

Strong understanding of medical device regulations and standards

Ability to manage multiple projects and deadlines

Education

Bachelor’s degree in Technical Writing, Engineering, Life Sciences, or related field

Tools

Microsoft Word

Adobe Acrobat

XML/DITA authoring systems

Job description

ECI in Burlingame, California is seeking a Senior Technical Writer to create and maintain high-quality documentation for medical devices. The role involves developing user manuals, collaborating with teams across engineering and quality, and ensuring compliance with regulatory standards such as FDA and ISO. The ideal candidate should have a Bachelor’s degree in a related field and at least 5 years of relevant experience. ECI offers a welcoming team and is committed to equal opportunity employment.