Senior Device Engineer I: Design Transfer & Validation

Medasource; Foster City (CA); On-site; USD 125,000 - 150,000; Full time

Job summary

Medasource is seeking a Senior Device Engineer I in Foster City, CA for an 18-month on-site contract. The role drives commercial readiness and life cycle management of drug-device combination products, supporting manufacturability assessments, design verification builds, and design transfer activities.

You will apply expertise in process development, design controls, product transfer, and process validation, collaborating with late-stage teams and external manufacturers.

Qualifications

• Bachelor’s degree in mechanical, chemical, biomedical engineering, material science, or related field with 8+ years of industry experience, or Master’s degree with 6+ years.
• Experience with design transfer, process validation, and regulatory requirements for drug-device combos.
• Strong documentation, root cause analysis and deviation investigations skills.

Responsibilities

• Perform product and process characterization studies and manufacturability assessments during design and development.
• Represent Device Engineering on late-stage device project teams.
• Lead design transfers to internal and external manufacturing sites, select and specify manufacturing equipment, and author/review design control documents.
• Drive clinical and commercial change records and support investigations and deviations.
• Support design verification and clinical product manufacturing builds.
• Support equipment qualification and process validation activities.

Skills

Medical device development

Process validation

Design controls

Root cause analysis

Equipment qualification

Documentation writing

Verbal/written communication

Education

Bachelor’s in mechanical/chemical/biomedical/material science

Master’s degree +6 years experience

Tools

RFPs & vendor management

Job description

Medasource is seeking a Senior Device Engineer I in Foster City, CA for an 18-month on-site contract. The role drives commercial readiness and life cycle management of drug-device combination products, supporting manufacturability assessments, design verification builds, and design transfer activities.

You will apply expertise in process development, design controls, product transfer, and process validation, collaborating with late-stage teams and external manufacturers.