Biomedical Engineer I (Medtech)

TL;DR

Biomedical Engineer I (Medtech): Developing and running insulin compatibility and biocompatibility testing for insulin pump platforms with an accent on test protocol execution, sample preparation, and regulatory report writing. Focus on utilizing HPLC for analysis, managing outsourced lab relationships, and ensuring compliance with safety and regulatory standards.

Location: On-site five days a week in Del Mar, CA

Salary: $75,000–$90,000

Company

hirify.global is a leader in the diabetes technology industry, specializing in advanced insulin delivery systems like the Tandem Mobi and t:slim X2.

What you will do

• Execute test protocols for insulin compatibility, including setup, pumping profiles, and sample collection.
• Manage vendor relationships with outsourced laboratories, including reviewing quotes and coordinating sample shipping.
• Participate in test planning and write technical reports to support regulatory submissions.
• Review specifications for test fixtures and system performance to verify functionality and document verification.
• Design experiments and formulate hypotheses to inform product decision-making and engineering improvements.
• Develop detailed work instructions and ensure strict compliance with HIPAA and other legal/regulatory requirements.

Requirements

• Bachelor's degree in biomedical engineering, Biology, Chemistry, or a related field.
• At least 6 months of experience in a lab setting developing test methods and writing detailed reports.
• Knowledge of Good Documentation Practices (GDP).
• Proficiency with MS Office.
• Ability to present technical information and collaborate effectively across all levels of the organization.

Nice to have

• Experience and knowledge of High-Performance Liquid Chromatography (HPLC).
• Exposure to testing methodology within a product development environment.

Culture & Benefits

• Comprehensive healthcare benefits including medical, dental, and vision available from the first day.
• Financial security with a 401k plan featuring company match and an Employee Stock Purchase plan.
• Generous time off with 11 paid holidays per year and a minimum of 20 days PTO.
• Access to Health Savings Accounts (HSA) and Flexible Saving Accounts (FSA).
• Inclusive environment that emphasizes a "people first" approach and personal connection to the medical cause.