Senior Design Controls Engineer – Training & Compliance

Intuitive; Sunnyvale (CA); On-site; USD 102,000 - 113,000; Full time

Job summary

Intuitive is hiring a Design Controls Engineer to join the Product Quality organization, focusing on safe, compliant medical device design and documentation. This role supports training, content development, and governance of GDP for regulatory submissions.

You will collaborate with Design Engineering and New Product Introduction teams, mentor stakeholders, and help implement new tools and best practices to enhance design control documentation quality.

Qualifications

• Bachelor’s degree in engineering, science or other technical area.
• Minimum 3 years of experience in a technical field; medical devices preferred.
• Experience with ISO 14971, ISO 13485 and 21 CFR Part 820 regulatory requirements.
• Experience writing and reviewing design control documents and risk analyses.

Responsibilities

• Provide coaching on design controls, quality processes, and risk analysis to diverse stakeholders.
• Develop and deliver training content for Design Controls tools and processes.
• Assist with regulatory submissions and regulatory documentation maintenance (DHF) as needed.
• Support ECOs and GDP adherence across design control documents.

Skills

Agile PLM experience

Technical writing

Cross-functional collaboration

Regulatory knowledge

Education

Bachelor’s degree in engineering, science or technical area

Tools

Polarion ALM

LMS (Learning Management System)

MS Office (Excel/Word/PowerPoint)

Job description

Intuitive is hiring a Design Controls Engineer to join the Product Quality organization, focusing on safe, compliant medical device design and documentation. This role supports training, content development, and governance of GDP for regulatory submissions.

You will collaborate with Design Engineering and New Product Introduction teams, mentor stakeholders, and help implement new tools and best practices to enhance design control documentation quality.