Sr. Device Engineer

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

Job Title: Senior Device Engineer - Combination Products Process Engineering

Contract Length: 18-months, with possibility of extension

Description

The Device Development and Clinical Packaging Engineering department is seeking a qualified

Senior Device Engineer I to drive commercial readiness and life cycle management of drug-

device combination products. This individual will be responsible for supporting manufacturability assessments, design verification builds, clinical builds, and design transfer and commercialization activities. This role requires expertise in process development, design

controls, product/technology transfer, and process validation.

Specific Job 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 complaints investigations and deviations.
• Support design verification and clinical product manufacturing builds.
• Support equipment qualification and process validation activities.

Knowledge & Skills

• Experience and knowledge with medical device and combination product development and manufacturing including process validation and related global regulatory requirements.
• Experience with design, execution, and statistical analysis of process characterization studies.
• Experience with root cause analysis, deviation management, and investigations.
• Experience working with equipment vendors and manufacturers including creating RFPs, developing user requirements, and qualifying equipment.
• Strong verbal, written, and interpersonal communication skills are required.
• Must be able to write clear, concise, and error-free documents.

Education & Experience

• A Bachelor's Degree in mechanical engineering, chemical engineering, biomedical engineering, material science, or a related scientific field and a minimum of eight (6) years of relevant industry experience, OR a Master's Degree and a minimum of six (4) years of relevant industry experience.