Senior Device Engineer - Combination Products & Process Transfer

Medasource; Foster City (CA); On-site; USD 120,000 - 170,000; Full time

Job summary

Medasource is seeking a Senior Device Engineer I to drive commercial readiness and lifecycle management of drug-device combination products. You will support manufacturability assessments, design verification builds, clinical builds, and technology transfer and commercialization activities.

Ideal candidates have expertise in process development, design controls, product transfer, and process validation, with strong collaboration across manufacturing sites and quality/regulatory teams.

Qualifications

• Experience with medical device and combination product development.
• Experience designing, executing, and analyzing process characterization studies.
• Experience with design review, change control, and regulatory requirements.

Responsibilities

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

Skills

Process development

Design controls

Statistical analysis

Root cause analysis

Vendor collaboration

Documentation writing

Education

Bachelor's degree in engineering

Master's degree in related field

Job description

Medasource is seeking a Senior Device Engineer I to drive commercial readiness and lifecycle management of drug-device combination products. You will support manufacturability assessments, design verification builds, clinical builds, and technology transfer and commercialization activities.

Ideal candidates have expertise in process development, design controls, product transfer, and process validation, with strong collaboration across manufacturing sites and quality/regulatory teams.