Senior Device Engineer I

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

~3 days/week depending on team schedule, flexible but Tues-Thurs likely on site

18 mo. contract

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.

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 (8) years of relevant industry experience,
• OR a Master's Degree and a minimum of six (6) years of relevant industry experience.