Device Assembly Process Engineer

AstraZeneca • Gaithersburg, MD

2d • $79,337 - $119,005

About The Position

The Device Assembly Process Engineer supports assembly process development for medical devices and combination products, potentially including accessorized prefilled syringes, auto-injectors, and other devices. The role provides technical leadership for a fill-finish and assembly pilot laboratory with capabilities such as vial and syringe filling, lyophilization, and device assembly. It develops risk assessment tools, study protocols, and report templates, and applies rigorous experimental design and data analysis across projects. The engineer also reviews academic, regulatory, and vendor literature, maintains current technical knowledge, and communicates findings to the team.

The position characterizes assembly processes through risk analyses and laboratory or engineering studies. It evaluates assembly methods and their effects on device or combination product performance, designs process steps, and establishes operational design spaces and control strategies. The role supports engineering and Clinical/Commercial GMP runs at assembly sites, reviews and approves batch records, validation protocols, and other GMP documents, provides on-site assembly support, helps close non-conformances, and contributes to regulatory writing for clinical and commercial filings.

The engineer assists with or leads late-stage and commercial design transfer of assembly processes to contract manufacturing organizations and internal facilities for parenteral biopharmaceutical or synthetic drug products, including technical support for clinical technology transfer as needed. This includes organizing cross-functional sending-unit teams, managing internal timelines and activities, communicating goals, tracking work at receiving sites, and managing design-transfer documentation. Some travel is required, typically one to two trips per year in the United States and abroad.

The role requires a degree in Mechanical Engineering, Biomedical Engineering, a related engineering field, or pharmaceutical science. Candidates must have either a bachelor's degree and at least five years of relevant experience, or a master's degree and at least two years of medical-device or combination-product experience. Relevant backgrounds may include combination-product development and manufacturing processes, quality oversight, validation, GMP process development, device development, or small-molecule parenteral work. Experience in design transfer or leading multifunctional teams is valuable; knowledge of injection molding and polymer materials science is helpful. A high degree of self-motivation, mechanical skill, technical rigor, communication ability, and technical-writing skill is required.

Requirements

• A degree in Mechanical Engineering, Biomedical Engineering, a related engineering field, or pharmaceutical science.
• A bachelor's degree and at least five years of relevant experience, or a master's degree and at least two years of medical-device or combination-product experience.
• Capability, skill, or knowledge in biopharmaceutical or combination drug-product development.
• Capability, skill, or knowledge in combination-product and cGMP regulations.
• Capability, skill, or knowledge in assembly, labeling, and packaging processes and equipment.
• Capability, skill, or knowledge in validation of equipment, processes, and shipping configurations.
• Capability, skill, or knowledge in QbD, experimental design, statistics, and data analysis.
• Leadership and interpersonal communication skills.
• Technical writing and documentation skills.
• High degree of self-motivation, mechanical skill, and technical rigor.
• Strong communication and technical-writing skills.

Nice To Haves

• Experience developing combination products or associated manufacturing processes, or in quality oversight or validation of device or combination-product assembly processes.
• Design-transfer experience or experience organizing and leading multifunctional teams.
• Knowledge of injection molding and polymer materials science.
• GMP process-development experience, such as in technical services or validation.
• Experience in device development or a small-molecule parenteral background.

Responsibilities

• Provide technical leadership for a fill-finish and assembly pilot laboratory, including vial and syringe filling, lyophilization, and device assembly capabilities.
• Develop risk assessment tools, study protocols, and report templates.
• Apply rigorous experimental design and data analysis across projects; review relevant academic, regulatory, and vendor literature and communicate findings.
• Perform risk analyses and laboratory or engineering studies to characterize assembly processes.
• Test, analyze, and interpret assembly methods and their effects on device or combination product performance, including injection time and glide force.
• Design process steps and establish operational design spaces and control strategies.
• Support engineering and Clinical/Commercial GMP runs at assembly sites.
• Review and approve batch records, validation protocols, and other GMP documents.
• Provide on-site support for assembly activities and help close non-conformances.
• Support regulatory writing for clinical and commercial filings.
• Assist with or lead late-stage and commercial design transfer of assembly processes to CMOs and internal facilities, including clinical technology transfer support as required.
• Organize cross-functional internal sending-unit teams spanning development functions, operations, supply chain, project management, and quality assurance.
• Manage internal design-transfer timelines and activities, communicate goals, track work at receiving sites, and manage design-transfer documentation.
• Travel in the United States and abroad as needed, typically one to two trips per year.

Benefits

• Short-term incentive bonus opportunity.
• Eligibility for the equity-based long-term incentive program for salaried roles.
• Retirement contribution for hourly roles.
• Commission payment eligibility for sales roles.
• Qualified retirement program (401(k) plan).
• Paid vacation and holidays.
• Paid leaves.
• Medical, prescription drug, dental, and vision coverage.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level