Medical Device - Operations Manager - Billerica, MA

The Operations Manager will oversee daily production and technical operations, ensuring efficiency and quality. They will collaborate with cross-functional teams to drive process improvements and manage new product introductions.

Client Details

Our client is a medical diagnostics company specializing in rapid, near-patient testing solutions that enable swift, informed decisions in critical care settings. Its platform delivers fast, lab-accurate results and is FDA-approved.

Description

The Operations Manager's Responsibilities Include:

• Collaborating with R&D teams to align operations with product development goals
• Optimizing and refining production processes for efficiency and scalability
• Leading efforts to redevelop and enhance existing products
• Managing 2-3 active New Product Introduction (NPI) projects
• Troubleshooting and resolving production-related issues in real time
• Overseeing a small operations team of 2 to 3 individuals
• Coordinating cross-functional technical operations to ensure alignment and delivery
• Handling technology transfer activities between development and manufacturing
• Supporting scale-up of manufacturing processes for new and existing products
• Driving continuous improvement initiatives across operational workflows

Profile

Ideal Operations Manager:

• 5-7 years of hands-on experience in a relevant scientific or technical role
• Background in ELISA techniques or antibody manufacturing processes
• Familiarity with FDA regulatory standards and compliance requirements
• Knowledge of chemical binding principles and applications
• Proven ability to collaborate effectively across multidisciplinary teams
• Experience with coding and antibody conjugation is highly desirable
• Bachelor's degree in a relevant scientific field required
• Master's degree or PhD preferred
• Demonstrated leadership experience is essential
• Strong work ethic and a genuine passion for advancing diagnostic technologies

Job Offer

What's To Offer:

• Competitive base salary ranging from $110,000 to $140,000
• Comprehensive benefits package, including health, dental, and 401(k)
• Opportunities for internal advancement and career development
• Hands-on involvement with innovative, life-changing medical devices
• Chance to join a respected and recognized leader in the diagnostics industry

MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.