Device Engineer V

LeadStack Inc. is an award-winning, one of the nation's fastest-growing, certified minority-owned (MBE) staffing services provider of contingent workforce. As a recognized industry leader in contingent workforce solutions and Certified as a Great Place to Work, we're proud to partner with some of the most admired Fortune 500 brands in the world.

Job Titles: Senior Technical Specialist / Device Engineer V

Location: Foster City, CA

Duration: 12 months Contract

Payrate: $70/hr - $100/hr on W2

Description

The Device Engineering team 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.
  
  

If you have any questions, feel free to call me on (415) 322-5419or send an email on akarsh.yathiraj@leadstackinc.com

Thanks and Regards

Akarsh YathirajSenior Recruiter C.(415) 322-5419D.(415) 322-5419A.611 Gateway Blvd, Ste 120

South San Francisco, CA 94080W.www.leadstackinc.com