Job Description

Position: Senior Technical Specialist - Combination Product Engineer

Location: Foster City, CA

Schedule: Hybrid (3 days onsite)

Contract Duration: 12-months

Target Start Date: Late March / Early April

Position Overview:

Our client is seeking a Senior Technical Specialist – Combination Products to support lifecycle management activities for pharmaceutical products that include device components.

This role will focus on change control management, operational coordination, and risk management activities associated with commercial combination products. The position will play a key role in supporting an expanding pipeline of projects and coordinating changes across multiple global manufacturing sites.

The ideal candidate will bring experience working in regulated environments involving medical devices, pharmaceutical products, or drug-device combination products , along with strong organizational and cross-functional coordination skills.

Key Responsibilities:

Change Control Management

• Initiate, route, track, and close change control records related to product and manufacturing process updates.
• Support change management activities for drug-device combination products , including documentation associated with design controls.
• Coordinate cross-functional impact assessments involving engineering, quality, regulatory, and manufacturing teams.
• Manage changes initiated by vendors, suppliers, and internal engineering teams.

Operational & Project Coordination

• Support project coordination activities across multiple international manufacturing sites.
• Track and manage test sample builds, requests, and logistics .
• Coordinate delivery and inventory management of product samples used for testing or validation.
• Assist with documentation and reporting required for product lifecycle activities.

Risk Management & Post-Market Support

• Support risk management file maintenance and updates.
• Contribute to device risk assessments and annual risk summaries.
• Compile and organize information for post-market surveillance reporting .
• Support investigations related to product complaints or field issues.

Required Qualifications:

• 3–5+ years of industry experience in medical devices, pharmaceuticals, or combination products.
• Experience working within regulated environments (cGMP, medical device regulations, or combination products) .
• Demonstrated experience managing or supporting change control processes .
• Strong organizational and project coordination skills .
• Ability to collaborate across cross-functional teams and global manufacturing sites .
• Bachelor's degree in engineering, life sciences, or related technical discipline .

Preferred Qualifications:

• Experience working with drug-device combination products .
• Familiarity with risk management frameworks such as ISO 14971 .
• Experience supporting design control documentation and product lifecycle management .
• Experience working with quality management systems such as Veeva Vault or similar platforms .
• Exposure to post-market surveillance or complaint investigation processes .

Key Skills:

• Change control management
• Combination products or medical device lifecycle management
• Risk management documentation
• Cross-functional project coordination
• Regulated product development and manufacturing

EEO Statement:

Medasource is an equal opportunity employer that does not discriminate on the basis of actual or perceived race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth, lactation and related medical conditions), gender identity or gender expression, sexual orientation, marital status, military service and veteran status, physical or mental disability, protected medical condition as defined by applicable state or local law, genetic information, or any other characteristic protected by applicable federal, state, or local laws and Ordinances.

Benefits & Perks:

Medasource 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.

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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