Principal Scientist – Device Technical and Engineering Lead – Inhalation Programs

MSD

Leading inhalation drug-device combination product development at Merck, a global healthcare company. Directing device strategy, aerosol performance, manufacturing readiness, regulatory submissions, and cross-functional teams.

Posted 8/6/2026full-timeRemote • New Jersey, Pennsylvania • 🇺🇸 United StatesSenior💰 $156,900 - $247,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive expertise in inhalation drug-device combination product development, including regulatory submission processes, design controls, and risk management. Proven ability to lead cross-functional teams and manage complex projects while ensuring compliance with industry regulations and standards.

Highest-signal resume keywords

Inhalation Device DesignRegulatory Submission ExperienceDevice Development LeadershipRisk Management ExpertiseCross-Functional Team Leadership

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Device DevelopmentDesign ControlsAerosol Performance VerificationHuman Factors EngineeringProcess DevelopmentRegulatory ComplianceAnalytical JudgmentValidation StrategyFormulation CompatibilityProject Management

Soft Skills

Excellent CommunicationPresentation SkillsNegotiation SkillsOrganizational SkillsInfluencing Without Authority

Industry Keywords

Biopharmaceutical DevelopmentMedical Device RegulationsCGMPFDA GuidanceISO StandardsCombination ProductsHealthcare RegulationsDevice Working GroupsClinical Supplies ProductionRespiratory Delivery Programs

Tech Stack

Tools & technologies

Assembly

About the role

Key responsibilities & impact

Set tactical and strategic direction for inhalation drug-device combination product programs
Lead inhalation subject-matter activities across dry powder inhalers, nebulized therapies, and other respiratory delivery programs
Lead device development strategies from concept generation and platform assessment through feasibility, development, verification, validation, and launch readiness
Lead cross-functional Device Working Groups integrating clinical, regulatory, formulation, commercial, human factors, quality, and manufacturing activities
Lead Device Development Engineering Core teams defining design requirements and engineering execution
Represent Device Development and Device Working Groups on cross-functional development and commercialization teams
Engage with external inhalation CDMOs, device designers/developers, component suppliers, and manufacturing partners
Oversee technical integration of formulation-device compatibility, device assessment, manufacturing, aerosol performance testing, design controls, risk management, verification, validation, assembly, and human factors activities
Anticipate and resolve technical and project obstacles and communicate challenges, risks, timelines, and milestones
Author and review regulatory submission content for INDs, IMPDs, NDAs, BLAs, and related combination product programs
Lead or support clinical supplies production, device component manufacture, and final assembly
Improve Device Development and Device Project Leader processes, procedures, and tools
Maintain design controls and design history file development, including user needs, design inputs, risk controls, verification evidence, and validation strategy
Monitor inhalation technologies, respiratory platforms, regulations, standards, and industry developments
Enhance the company’s professional image through publications, presentations, patents, and professional activities

Requirements

What you’ll need

B.A./B.S. in Pharmaceutical, Science, Biomedical, or Engineering-related subject
Minimum 10 years of combined experience in biopharmaceutical, medical device, and combination product development
5+ years of leadership experience with device, biologic/drug product, and process development, including regulatory submission and approval processes
5+ years of leadership experience managing complex device or combination product development programs and leading cross-disciplinary project teams
Broad knowledge of medical device development, design controls, and risk management
Deep knowledge of inhalation device design, requirements management, device and aerosol performance verification, automation/process development, design validation, human factors, and control strategy
Knowledge of U.S. and global drug-device combination product, medical device, and healthcare regulations
Knowledge of FDA combination products cGMP, Quality System Regulation, FDA Human Factors guidance, ISO 14971, ISO 11608, ISO 11040, EN 62366, and Council Directive 93/42/EEC
Proven experience applying analytical and technical judgment to inhalation product or manufacturing process design, development, validation, and lifecycle management
Ability to interpret device, aerosol, formulation, and process performance data
Ability to work independently and lead team members with different skill sets and backgrounds
Ability to influence without formal authority and present ideas to senior leadership
Excellent communication, presentation, negotiation, project management, and organizational skills
Experience leading complex development projects at enterprise level
Willingness to travel
Ability to continuously multitask
Experience with inhalation drug products, inhalation drug-device combination products, or respiratory device components strongly preferred
Advanced degree preferred

Benefits

Comp & perks

Annual bonus eligibility
Long-term incentive eligibility, if applicable
Medical, dental, and vision healthcare
Other insurance benefits for employee and family
Retirement benefits, including 401(k)
Paid holidays
Vacation
Compassionate and sick days
Remote work arrangement