Sign upLog in

Senior Device Engineer

Lancesoft

Foster City, CA

Apply
JOB DETAILS
SKILLS
Biotech and Pharmaceutical, Change Control, Change Management, Contract Management, Contract Manufacturing, Current Good Manufacturing Practice (cGMP), Document Management, Drug Development, Drug Products, File Maintenance, Logistics, Manufacturing/Industrial Processes, Medical Equipment, Product Control, Product Management, Project/Program Management, Purchasing/Procurement, Regulations, Risk, Risk Management, Specimens/Samples, Surveillance, Testing, Time Management
LOCATION
Foster City, CA
POSTED
30+ days ago
Description
The Device Engineering team at Gilead is seeking a qualified individual to support drug device combination products throughout the commercial lifecycle. This individual will be responsible for the management of combination product change records. Additional responsibilities include test sample management, post market surveillance reports, and risk management file maintenance.

Job Responsibilities
Coordinate and manage combination product change control records
Initiate, route, and close change records for product and manufacturing process changes.
Initiate, route, and close change records for the design and development of drug device combination products, including the creation and management of design control documentation.
Coordinate and manage test sample builds
Manage sample requests and procurement.
Coordinate test sample delivery logistics.
Coordinate post-market surveillance reports and risk management file updates
Collate surveillance information into yearly reports.
Generate annual risk summaries and update risk management files.
Support complaint investigations.

Knowledge & Skills
Exceptional organizational and time management skills.
Understanding of change controls in a regulated industry.
Experience with project management.
Working knowledge of relevant US, EU, and international medical device and pharmaceutical regulations.
Experience with Veeva Vault.
Ability to work with team members, vendors, suppliers, and contract manufacturers to coordinate changes.

Education & Experience
3 5 years relevant experience in related field and a BS or BA.
Experience with medical device development and / or pharmaceutical operations (cGMP environment) required.

This could also be a Sr Device Engineer would have the addition of device development experience.

About the Company

L

Lancesoft

We are a $125 Million, NMSDC-certified Minority & Woman owned Workforce Solutions Company headquartered in the DC metro area with presence across US with global presence - Canada, Mexico, India, UK, Malaysia, Indonasia, Hongkong, Singapore, UAE. We are specialized in providing Workforce Solutions, SOW project delivery, Engineering Solutions, Creative Services. We currently support 100+ Fortune companies globally and across multiple industry segments. We are currently supporting several massive programs across industry segment nationally/globally (Intel, Ally, AMD, QUALCOMM, Morgan Stanley, Kraft/ Mondelez, MNP, Amdocs, Dell, SanDisk, Medtronic, Becton Dickinson, GE, Lockheed Martin, UTC, L-3 Communications, Caterpillar, BMW, Mercedes Benz, National Grid, Dominion, Energy Future Holdings, PSEG, 3M, Fidelity, Aetna, Humana, Johnson & Johnson, Pfizer, Merck etc). 

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender, identity, national origin, disability, or protected veteran status.

COMPANY SIZE
2,000 to 2,499 employees
INDUSTRY
Staffing/Employment Agencies
FOUNDED
2000
WEBSITE
http://www.lancesoft.com/