Consumable Quality Engineer
Description For Consumable Quality Engineer
Cellares is seeking a hands-on Consumable Quality Engineer to lead the testing and validation of consumables in compliance with ISO 10993, USP Class VI, and other relevant regulatory standards. This role works closely with various teams to ensure consumables are safe, compliant, and effective for use in advanced medical and pharmaceutical applications.
Key responsibilities include:
- Developing and leading qualification plans for consumables
- Designing and executing tests for biocompatibility, extractables and leachables, and more
- Coordinating with external labs for test execution
- Collaborating across departments to support consumable integration
- Analyzing test results and producing technical reports
- Presenting findings to stakeholders
Requirements:
- BS/MS in Bioengineering, Chemical Engineering, or Material Science with 10+ years of experience, or PhD with 7+ years
- Deep understanding of biocompatibility standards
- Hands-on experience with qualification testing
- Strong communication skills
- Familiarity with medical device and pharmaceutical industries
Cellares offers a competitive compensation package, including base salary, health benefits, 401(k) matching, and stock options. The company is headquartered in South San Francisco, California, with a commercial-scale IDMO Smart Factory in Bridgewater, New Jersey. Backed by world-class investors, Cellares has raised over $355 million in financing.
Join Cellares to be part of a mission-driven team working on accelerating access to life-saving cell therapies through innovative manufacturing solutions.
Responsibilities For Consumable Quality Engineer
- Develop and lead qualification plans for consumables, ensuring compliance with regulatory standards (ISO 10993, USP Class VI)
- Design and execute tests, including biocompatibility, extractables and leachables, container closure integrity, sterilization validation, microbial ingress, and distribution testing
- Coordinate with external labs for execution of testing, ensuring accuracy and timeliness
- Collaborate across departments, including Systems Engineering, R&D, Mechanical Engineering, Quality, and Manufacturing, to support the integration of consumables into products
- Analyze test results and produce clear, detailed technical reports, protocols, and documentation
- Present findings to both technical and non-technical stakeholders and support continuous improvement initiatives in consumable qualification processes
Requirements For Consumable Quality Engineer
- BS/MS in Bioengineering, Chemical Engineering, or Material Science with 10+ years of relevant industry experience, or PhD with 7+ years
- Deep understanding of ISO 10993, USP Class VI, and other biocompatibility standards
- Hands-on experience with qualification testing for biocompatibility, extractables and leachables, sterilization, and other critical consumable tests
- Proven ability to manage external lab relationships for testing purposes
- Strong communication skills for preparing technical reports and collaborating with cross-functional teams
- Familiarity with the medical device and pharmaceutical industries, particularly around regulatory requirements
Benefits For Consumable Quality Engineer
- Medical Insurance
- Dental Insurance
- Vision Insurance
- 401k
- Stock options
- Free EV Charging
- Onsite lunches
