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Manager, Failure Investigation Engineering - Pleasanton, CA

Calyxo
Location
Pleasanton, CA
Posted
1 month ago
Department
Quality Systems
Salary
$150,000 - $170,000
What they actually want (must-haves)
  • Bachelor’s degree in Engineering, Life Sciences, or a related technical field; or equivalent practical experience
  • Minimum of 8 years of experience in the medical device industry, with a focus on post-market surveillance, complaint handling, or quality investigations
  • Strong working knowledge of applicable medical device regulations and global quality management systems (FDA, ISO 13485, EU MDR, etc.)
  • Demonstrated experience managing Class II or III medical devices; experience with sterile and/or electronic devices preferred
  • Proven leadership skills with a track record of developing high-performing teams
  • Excellent analytical, problem-solving, and technical writing skills
What the job really is

The Manager of Failure Investigation Engineering at Calyxo, Inc. leads a team responsible for investigating and resolving product complaints and adverse events related to medical devices. This role involves ensuring compliance with regulations, managing daily operations of investigations, and collaborating with various departments to maintain product safety and quality. The manager also mentors team members, drives continuous improvement, and participates in audits and reviews.

Benefits
  • A competitive base salary range of $150,000 - $170,000 and variable incentive plan
  • Stock options – ownership and a stake in growing a mission-driven company
  • Employee benefits package that includes 401(k), healthcare insurance and paid vacation
Things to weigh
  • No specific information on career advancement opportunities or professional development programs
  • The role involves managing a team, which may require strong interpersonal skills and conflict resolution abilities
  • The job requires compliance with vaccination and health requirements, which may be a consideration for some candidates
Job score4/5
Benefits2/5
Freshness4/5
Career value4/5
Role clarity5/5
Pay transparency5/5

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