Senior Device Engineer

Relocation assistance-is provided - US candidates only 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 - South Florida ( near Fort Lauderdale) w/ easy access from Boca Raton and Miami areas- **Florida is a NO STATE TAX state** Relocation Assistance is provided 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. Base Salary: $110,000 – $130,000 per year (could be more for the right candidate) PTO, 401k + full corporate benefits package. Relocation assistance provided " ttg Talent Solutions is an Equal Opportunity Employer and recruiting agency. We are committed to creating an inclusive and diverse work environment and welcome applications from all qualified candidates regardless of race, color, religion, gender, sexual orientation, national origin, age, disability, or veteran status. Please note that all offers of employment are contingent upon the successful completion of a drug test and background check. We maintain a drug- and substance-free workplace to ensure the safety and well-being of all employees #J-18808-Ljbffr