Job Description

Senior Medical Device Engineer

Well-established U.S. pharmaceutical R&D - Global

Western Broward County - South Florida

Relocation assistance

On-site | Full-time

ttg Talent Solutions is conducting a confidential search for a Senior Medical Device Engineer for a well-established U.S. pharmaceutical R&D center that is part of a global organization with a broad portfolio spanning generic, complex generic, and branded drug products. This hands-on role sits at the intersection of medical device engineering and pharmaceutical science, with a particular focus on inhalation and nasal drug-delivery systems, including dry powder inhalers (DPIs), metered-dose inhalers (MDIs), nasal sprays, and nebulizers.

Position Summary

The Senior Device Engineer will serve as the primary device and primary-packaging subject-matter expert within a cross-functional drug-product development organization, owning device development from early concept through commercial launch. The role requires technical depth, strong design-control and risk-management discipline, and the ability to challenge external partners, coach junior colleagues, and support regulatory interactions.

Key Responsibilities

Device Development and Engineering

• Serve as the primary device and primary-packaging subject-matter expert across drug-product development programs from early concept through commercial launch.
• Define and own product requirements for medical devices and drug-device combination products.
• Recommend and defend strategies for material selection, design concepts, cost reduction, high-volume manufacturability, and process efficiency, supported by data.
• Design, execute, interpret, and report device-development studies with emphasis on reliability testing, quality systems, and documentation rigor.
• Develop robust devices and manufacturing and analytical processes for combination products, including injection-molded plastic components.

Design Controls, Risk, and Quality

• Lead FMEA and FMECA risk-management activities and critically evaluate proposed technical solutions.
• Lead and monitor Design Control documentation activities, including development of high-quality Design History Files (DHF).
• Oversee human factors studies and related activities from planning through reporting.
• Apply strong quality-system discipline and ensure development activities align with cGMP requirements and applicable ISO, ASTM, and ICH standards.

Cross-Functional, External, and Regulatory Leadership

• Lead collaboration with internal teams and external development partners by setting expectations, monitoring progress against plan, and providing substantive technical challenge where needed.
• Support Regulatory Affairs in preparing pre-registration submissions for medical devices and combination products and contribute to responses to Health Authority questions.
• Lead or support direct interactions with regulatory bodies and relevant industry accreditation organizations.
• Coach and develop team members and contribute meaningfully to project sub-teams, broader departmental strategy, and organizational goals.

Required Qualifications

• Education: A relevant engineering degree at minimum (BSc or equivalent); an advanced degree in engineering or a scientific discipline (MSc or equivalent) is highly desirable.
• Experience: At least five years in the medical device industry, with pharmaceutical development exposure strongly preferred. Hands-on experience with DPIs, MDIs, nasal sprays, and/or nebulizers is a meaningful differentiator.
• Design and Manufacturing Depth: Demonstrated experience in product design, injection molding of plastic components, and equipment qualification. Proficiency with force-measurement and metrology tools. A background in electrical engineering or materials science is a plus.
• Regulatory and Quality Fluency: Working knowledge of Design Control processes, cGMP requirements, and applicable ISO, ASTM, and ICH standards. Experience conducting FMEA, FMECA, and Human Factors Analysis.
• Tools: Proficiency with SolidWorks, CAD platforms, and standard technical software environments used in medical device development.
• Leadership: Proven ability to lead in a matrix organization by setting direction, building alignment, and developing people without relying on direct authority.
• Communication: Strong written and verbal communication skills, including technical and scientific writing and the ability to present complex information clearly to cross-functional and regulatory audiences.
• Work Location: Ability and willingness to work full-time on-site in the Broward County in South Florida. - easy access from Fort Lauderdale, Boca and Miami. ( no state income tax )

Core Competencies

• Cross-functional collaboration and stakeholder management.
• Customer and patient centricity.
• Developing talent and coaching others.
• Innovation, creative problem-solving, and strategic agility in a regulated environment.
• Process discipline, technical rigor, and result orientation.

Why This Opportunity

This is an opportunity to join a technically sophisticated R&D environment and lead device engineering across high-value drug-device combination products, with meaningful ownership from concept through commercialization and direct influence on product quality, manufacturability, regulatory readiness, and patient experience.

Compensation

Base Salary: $110,000 – $130,000 per year (could be more for the right candidate) + full corporate benefits package, 401K, PTO and more . Relocation assistance provided

Please apply on-line for immediate consideration. If you are match, you will be contacted by email, phone or text. Monitor your inbox, VM and spam for messages from the recruiter!!