Device Engineer - V

Aptask Global Workforce (AGW) is seeking a Device Engineer - V for an Onsite position. This is a with 12+ month contract located in Foster City, CA.

The Device Engineering team at a major Pharmaceutical Company 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.

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

Requirements:

• 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
• 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
• Only candidates available and ready to work directly as Aptask Global Workforce (AGW) employees will be considered for this position.

Pay range: Up to $102.67per hour

If you have the described qualifications and are interested in this exciting opportunity, apply today!

Aptask Global Workforce (AGW)

ApTask Global Workforce (AGW) is a certified Minority and Veteran workforce solutions company. AGW delivers operational, clinical, lab and professional talent with a strong focus on healthcare and life sciences. The company supports clients with reliable staffing, program expertise and a commitment to quality, speed and consistent delivery.

Benefits of working with ApTask Global Workforce include:

• Medical
• Dental
• Vision
• Sick Pay (for applicable states/municipalities)

Our team stays close to the process and is here to guide you every step of the way. To learn more, please visit our website https://www.agwtalent.com/.

ApTask Global Workforce is an Equal Opportunity Employer. Candidates will receive consideration without regard to their race, color, religion, sex, sexual orientation, gender identity, national origin, disability or status as a protected veteran.