Technical Operations Manager- Medical Device- Chelmsford, MA Position Available In Middlesex, Massachusetts

Job Description:

A growing diagnostics company is hiring a Technical OperationsManager to lead technical efforts for a near-patient testingplatform focused on real-time biomarker analysis for acuteconditions like sepsis. The role requires deep expertise inimmunochemistry, assay development, and technology transfer, with afocus on scaling up manufacturing. Client Details A rapidly growingdiagnostics company is expanding its technical engineering teamduring a pivotal phase of growth. With recent FDA feedbackindicating market readiness for its flagship product, theorganization is poised to transition from development tocommercialization. If you’re passionate about advancing healthcareand are looking for a leadership role in a high-impact technicalenvironment, we encourage you to apply and learn more. DescriptionThe Technical Operations Manager will be responsible for:

Bachelor’s in Biochemistry, Immunology, Biomedical Engineering, orrelated field; Master’s or PhD highly preferred. 7 years ofexperience in the IVD, medical device, or diagnostics space, withhands-on expertise in immunoassay development and manufacturing.

Proven track record in successful tech transfer from R D tomanufacturing-both internal and outsourced environments. Deepexperience with antibody-based assay development, reagentselection, and performance optimization. Solid understanding of FDAregulatory pathways (510(k), PMA, EUA) and experience supportingrelated submissions. Familiar with design controls, ISO 14971 riskmanagement, and

QSR/ISO 13485

requirements. Skilled in supportingclinical trials and generating analytical and clinical validationdata. Experience managing vendors, CROs, and CMOs. Strong projectmanagement capabilities-able to juggle priorities, timelines, andmultiple stakeholders. Excellent communication and documentationskills with a knack for translating technical details into clearaction across teams. Profile The successful Technical OperationsManager will have a background as follows: 7 years of experience inmedical device, biotechnology or related field MUST have someleadership experience Experience with point-of-care or near-patientdiagnostic platforms, especially those using microfluidiccartridges. Exposure to clinical studies involving biomarkers likeIL-6 or CRP, including real-time data integration. Familiarity withautomated manufacturing of IVD consumables and scale-up ofcartridge-based or microfluidic systems. Understanding of reagentsupply chains and experience managing global CMOs/CROs. Solid graspof the regulatory landscape related to diagnostics and medicaldevices. Job Offer The successful Technical Operations Manager willbe offered:

Competitive Compensation:

A strong base salary withperformance-based bonus potential.

Equity/Stock Options:

Ownershipopportunities in a fast-growing, innovation-driven company.

Health& Wellness:

Comprehensive medical, dental, and vision insurance,plus wellness benefits.

Retirement Planning:

401(k) with companymatch or similar retirement plans.

Work-Life Balance:

Generous PTO,paid holidays, and flexible work arrangements when possible.

CareerGrowth:

Opportunity to lead critical programs with high visibility,influence company direction, and grow with the organization.

Mission-Driven Culture:

Join a passionate team focused ondelivering impactful diagnostics that improve patient outcomes. MPIdoes 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 anindividual’s status in any group or class protected by applicablefederal, state or local law. MPI encourages applications fromminorities, women, the disabled, protected veterans and all otherqualified applicants.