Technical Operations Manager- Medical Device- Chelmsford, MA

A growing diagnostics company is hiring a Technical Operations Manager to lead technical efforts for a near-patient testing platform focused on real-time biomarker analysis for acute conditions like sepsis. The role requires deep expertise in immunochemistry, assay development, and technology transfer, with a focus on scaling up manufacturing.

Client Details

A rapidly growing diagnostics company is expanding its technical engineering team during a pivotal phase of growth. With recent FDA feedback indicating market readiness for its flagship product, the organization is poised to transition from development to commercialization. If you're passionate about advancing healthcare and are looking for a leadership role in a high-impact technical environment, we encourage you to apply and learn more.

Description

The Technical Operations Manager will be responsible for:

• Bachelor's in Biochemistry, Immunology, Biomedical Engineering, or related field; Master's or PhD highly preferred.
• 7+ years of experience in the IVD, medical device, or diagnostics space, with hands-on expertise in immunoassay development and manufacturing.
• Proven track record in successful tech transfer from R&D to manufacturing-both internal and outsourced environments.
• Deep experience with antibody-based assay development, reagent selection, and performance optimization.
• Solid understanding of FDA regulatory pathways (510(k), PMA, EUA) and experience supporting related submissions.
• Familiar with design controls, ISO 14971 risk management, and QSR/ISO 13485 requirements.
• Skilled in supporting clinical trials and generating analytical and clinical validation data.
• Experience managing vendors, CROs, and CMOs.
• Strong project management capabilities-able to juggle priorities, timelines, and multiple stakeholders.
• Excellent communication and documentation skills with a knack for translating technical details into clear action across teams.

Profile

The successful Technical Operations Manager will have a background as follows:

• 7+ years of experience in medical device, biotechnology or related field
• MUST have some leadership experience
• Experience with point-of-care or near-patient diagnostic platforms, especially those using microfluidic cartridges.
• Exposure to clinical studies involving biomarkers like IL-6 or CRP, including real-time data integration.
• Familiarity with automated manufacturing of IVD consumables and scale-up of cartridge-based or microfluidic systems.
• Understanding of reagent supply chains and experience managing global CMOs/CROs.
• Solid grasp of the regulatory landscape related to diagnostics and medical devices.

Job Offer

The successful Technical Operations Manager will be offered:

• Competitive Compensation: A strong base salary with performance-based bonus potential.
• Equity/Stock Options: Ownership opportunities in a fast-growing, innovation-driven company.
• Health & Wellness: Comprehensive medical, dental, and vision insurance, plus wellness benefits.
• Retirement Planning: 401(k) with company match or similar retirement plans.
• Work-Life Balance: Generous PTO, paid holidays, and flexible work arrangements when possible.
• Career Growth: Opportunity to lead critical programs with high visibility, influence company direction, and grow with the organization.
• Mission-Driven Culture: Join a passionate team focused on delivering impactful diagnostics that improve patient outcomes.

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.