Device Development Engineer

Medasource; Foster City (CA); On-site; USD 96,000 - 138,000; Full time

Job summary

Medasource is seeking a highly skilled Device Development Engineer (Contractor) to support parenteral drug-device combination products, including vials and prefilled syringe systems. The role focuses on planning and executing device testing, data analysis, and design control documentation for clinical development activities.

The ideal candidate has hands-on experience with prefilled syringe or injectable delivery systems, strong design controls knowledge, and a track record of producing

Qualifications

• Bachelor’s or Master’s degree in Mechanical, Biomedical, Chemical Engineering or related field.
• Minimum of 2+ years (MS) or 4+ years (BS) of relevant experience in combination product development.
• Strong understanding of design controls, risk management, and regulatory standards for combination products.

Responsibilities

• Support technical development activities for combination products from concept through clinical introduction, including conducting feasibility/characterization and pre-Design Verification testing.
• Develop and execute design control documentation, including design inputs/outputs, verification, validation, and risk management.
• Perform root cause investigations, technical assessments, and risk evaluations to support issue resolution and design decisions.
• Prepare technical memoranda, engineering assessments, and development reports to support regulatory submissions and project milestones.
• Independently coordinate laboratory activities including sample management, test execution, troubleshooting, and documentation of results.
• Manage multiple characterization studies simultaneously while maintaining high-quality documentation practices.
• Analyze and interpret characterization data using statistical and graphical methods.
• Author technical reports, study summaries, and engineering assessments that clearly communicate findings, conclusions, limitations, and recommendations.
• Present test results and recommendations to cross-functional project teams and management.
• Collaborate with Quality, Regulatory, Clinical, Formulation Development, Manufacturing, and external partners to ensure timely execution of project deliverables.

Education

Master's degree or Bachelor's degree in Mechanical Engineering, Biomedical Engineering, Chemical Engineering, or related field

Job description

Contract Length: 12-months, with possibility of extension

Description

We are seeking a highly skilled and proactive Device Development Engineer (Contractor) to

support technical development efforts for parenteral drug-device combination products, including vials and prefilled syringe systems. This individual contributor will be responsible for

planning and executing device testing, analyzing data, and authoring design control documentation to support clinical development activities.

The ideal candidate has hands-on experience with prefilled syringe or injectable drug delivery

systems, a strong understanding of design controls and risk management, and a proven ability

to generate high-quality technical documentation with minimal oversight.

Specific Job Responsibilities

• Support technical development activities for combination products from concept through clinical introduction, including conducting feasibility/characterization and pre-Design Verification testing.
• Develop and execute design control documentation, including design inputs/outputs, verification, validation, and risk management.
• Perform root cause investigations, technical assessments, and risk evaluations to support issue resolution and design decisions.
• Prepare technical memoranda, engineering assessments, and development reports to support regulatory submissions and project milestones.
• Independently coordinate laboratory activities including sample management, test execution, troubleshooting, and documentation of results.
• Manage multiple characterization studies simultaneously while maintaining high-quality documentation practices.
• Analyze and interpret characterization data using statistical and graphical methods.
• Author technical reports, study summaries, and engineering assessments that clearly communicate findings, conclusions, limitations, and recommendations.
• Present test results and recommendations to cross-functional project teams and management.
• Collaborate with Quality, Regulatory, Clinical, Formulation Development, Manufacturing, and external partners to ensure timely execution of project deliverables.

Preferred Qualifications

• Bachelor’s or Master’s degree in Mechanical Engineering, Biomedical Engineering, Chemical Engineering, or related field.
• Minimum of 2+ years (MS) or 4+ years (BS) of relevant experience in combination product development.
• Strong understanding of design control, risk management, and regulatory standards for combination products.
• Experience with statistical analysis tools such as JMP or Minitab.
• Demonstrated ability to author protocol-driven studies and comprehensive technical reports suitable for design history files and regulatory submissions.
• Demonstrated ability to execute functional device testing.
• Excellent communication and collaboration skills; able to work effectively across functions and with external partners.

Education & Experience

• Master's and 2+ years of relevant experience OR Bachelor's and 4+ years of relevant experience.