Staff Quality Engineer in Alameda

Energy Jobline ZR
Alameda, US
On-site

Job Description

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Job Description

Staff Design Quality Engineer – Class III Implantable Medical Device

San Francisco Bay Area | Full-Time | Hybrid

A fast-growing medical device company developing next implantable technology is expanding its engineering team and hiring a Staff Design Quality Engineer to support the development of a highly innovative Class III medical device platform.

This is a highly technical, hands-on role embedded directly with R&D, focused on ensuring quality is built into product development from early feasibility through clinical and commercial stages.

You will play a key role in helping bring a breakthrough therapy to market while working alongside experienced engineers and cross-functional leaders in a collaborative development environment.

Responsibilities

  • Partner closely with R&D and systems engineering teams to integrate design quality into product development
  • Lead and support design control activities throughout the product lifecycle
  • Drive risk management efforts (ISO 14971) including hazard analysis, FMEAs, and risk mitigation strategies
  • Support verification and validation planning and execution
  • Ensure compliance with FDA design control requirements and global quality standards
  • Participate in cross-functional design reviews and technical decision making
  • Help translate regulatory and quality requirements into practical engineering processes

Qualifications

  • BS or MS in Engineering (Biomedical, Mechanical, Electrical, or related)
  • 7+ years of experience in medical device product development or design quality
  • Strong experience with design controls and risk management
  • Experience supporting Class II or Class III medical devices
  • Ability to collaborate closely with R&D in early-stage product development
  • Experience supporting IDE, PMA, or complex regulatory pathways is highly valued

What Makes This Opportunity Unique

  • Work on cutting-edge implantable technology
  • Join a highly technical engineering-driven team
  • Be involved early in the development lifecycle
  • Significant opportunity for technical ownership and influence
  • Competitive compensation, bonus, and equity package

If you are interested in learning more, feel free to reach out directly.

If you are interested in applying for this job please press the Apply Button and follow the application process. Energy Jobline wishes you the very best of luck in your next career move.

Skills & Requirements

Technical Skills

Design ControlsRisk ManagementISO 14971FMEAsVerification and ValidationFDA Design Control RequirementsRegulatory PathwaysCollaborationTechnical Decision MakingMedical DeviceEngineering

Employment Type

FULL TIME

Level

mid

Posted

3/27/2026

Apply Now

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