Combination Product Engineer

Senior Technical Specialist

Foster City, CA

Onsite (Hybrid: 3 days onsite per week)

Compensation: $100 - $125/hr

1-Year Contract

ABOUT THE ROLE

Our client is seeking a Senior Technical Specialist to join their team in Foster City, CA. This role is primarily onsite, with a hybrid schedule of three days per week in the office. The Senior Technical Specialist will play a critical role in coordinating and managing change control records for combination products, overseeing the initiation, routing, and closure of change records related to product, manufacturing process, and design development.

The position is also responsible for managing test sample builds-including procurement and logistics-coordinating post-market surveillance reports, updating risk management files, and supporting complaint investigations. The ideal candidate will have a strong background in medical device development and/or pharmaceutical operations within a cGMP environment, excellent organizational and project management skills, and a solid understanding of US, EU, and international medical device and pharmaceutical regulations.

Experience with Veeva Vault and the ability to collaborate with cross-functional teams, vendors, suppliers, and contract manufacturers is essential.

WHAT YOU'LL DO

• Coordinate and manage combination product change control records, including initiating, routing, and closing change records for product, manufacturing process, and design/development changes.
• Create and manage design control documentation for drug device combination products.
• Manage test sample builds, including handling sample requests, procurement, and coordinating delivery logistics.
• Coordinate and compile post-market surveillance reports, collate surveillance information into annual reports, and update risk management files, including generating annual risk summaries.
• Support complaint investigations related to combination products.
• Collaborate with team members, vendors, suppliers, and contract manufacturers to coordinate changes and ensure compliance.
• Ensure adherence to relevant US, EU, and international medical device and pharmaceutical regulations.
• Utilize Veeva Vault and other systems for documentation and process management.

WHAT YOU BRING

• BS or BA degree with 3-5 years of relevant experience in a related field.
• Experience with medical device development and/or pharmaceutical operations in a cGMP environment.
• 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 coordinate with team members, vendors, suppliers, and contract manufacturers.

Disclaimer: Brooksource, Medasource, and Calculated Hire are part of the Eight Eleven Group family of companies and operate under Eight Eleven Group, LLC. All employees receive the same benefits, policies, and terms of employment.

EEO:
We are committed to creating an inclusive environment for all employees and applicants. We do not discriminate on the basis of race, color, religion, creed, sex, sexual orientation, gender identity or expression, national origin, ancestry, age, disability, genetic information, marital status, military or veteran status, citizenship, pregnancy (including childbirth, lactation, and related conditions), or any other protected status in accordance with applicable federal, state, and local laws.

Benefits & Perks:
Eight Eleven Group offers competitive medical, dental, vision, Health Savings Account, Dependent Care FSA, and supplemental coverage with plans that can fit each employee's needs. We offer a 401k plan that includes a company match and is fully vested after you become eligible, paid time off, sick time, and paid company holidays. We also offer an Employee Assistance Program (EAP) that provides services like virtual counseling, financial services, legal services, life coaching, etc.

Pay Disclaimer:
The pay range for this job level is a general guideline only and not a guarantee of compensation or salary. Additional factors considered in extending an offer include (but are not limited to) responsibilities of the job, education, experience, knowledge, skills, and abilities, as well as internal equity, alignment with market data, applicable bargaining agreement (if any), or other law.

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