Staff Global Design Quality Engineer - Medical Devices

Dexcom Inc.; California (MO); On-site; USD 111,000 - 185,000; Full time

Benefits offered by this job

Comprehensive benefits

Global growth opportunities

Career development programs

Tuition reimbursement

Job summary

Dexcom Inc. seeks a Staff Design Quality Engineer (Global Expansions) to serve as the primary technical authority for design control, product risk management, and regulatory compliance across international markets.

The role drives regional adaptation and localization within the global product development lifecycle. You will lead DHF alignment, assess change controls and CAPA impacts, and act as the Quality contact for regulatory agencies during global expansions, collaborating with

Qualifications

• Bachelor's degree in a technical discipline; minimum 8–12 years related experience or Master’s degree with 5–7 years equivalent industry experience or PhD with 2–4 years experience.
• Experience in design quality engineering and assurance within medical device development.
• Experience leading global expansions in medical device development and collaborating with cross-functional teams.

Responsibilities

• Align Design History Files (DHFs) with compliance requirements of target international markets.
• Assess impact of change controls, CAPAs, and non-conformances on the overall system.
• Lead regulatory agency interactions as part of global expansions.
• Investigate CAPA and complaint investigations with Quality leadership.
• Identify, prioritize, communicate, and resolve quality issues across programs.

Skills

Design Quality Engineering

Regulatory compliance

Cross-functional collaboration

Communication skills

Education

Bachelor's degree

Master's degree

PhD

Job description

Dexcom Inc. seeks a Staff Design Quality Engineer (Global Expansions) to serve as the primary technical authority for design control, product risk management, and regulatory compliance across international markets.

The role drives regional adaptation and localization within the global product development lifecycle. You will lead DHF alignment, assess change controls and CAPA impacts, and act as the Quality contact for regulatory agencies during global expansions, collaborating with