Senior Engineer I – Device Development

AstraZeneca

Development Engineer in Device Development supporting medical device projects. Overseeing design verification testing and collaborating with cross-functional teams to ensure successful product development.

Posted 7/17/2026full-timeBoston • Maryland, Massachusetts • 🇺🇸 United StatesSenior💰 $97,000 - $146,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in product design and development within the medical device industry, with a strong focus on design control processes, risk management methodologies, and cross-functional collaboration. Proficient in statistical analysis and root cause investigation to ensure compliance with regulatory standards.

Highest-signal resume keywords

Product Design/Development EngineeringDesign Control ProcessStatistical Analysis (Minitab, Crystal Ball)Root Cause AnalysisRegulatory Compliance (EU and FDA)

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Mechanical EngineeringBiomedical EngineeringChemical EngineeringMaterials SciencePhase-Gated Product DevelopmentRisk Management MethodologiesBenchtop TestingAnalytical Tools (FEA)Technical DocumentationCharacterization and Design Verification Testing

Soft Skills

Clear CommunicationTeam BuildingCollaboration

Tools & Technologies

MinitabCrystal BallZwickFixture Design

Industry Keywords

Medical DeviceCombination ProductsRegulatory AffairsDevice QualityGlobal Technical Operations

About the role

Key responsibilities & impact

Serve as Development Engineer within the Alexion Device Development organization
Act as a technical SME/project engineer supporting the development of combination products
Accountable for key technical design and development deliverables
Interact with multiple functions and functional teams including Device Quality, Regulatory Affairs, Clinical, Global Technical Operations (GTO), and Alexion Dublin Manufacturing Facility (ADMF)
Oversee the characterization and design verification testing as well as determine relevant success criteria
Author technical documentation in support of the development process or design control deliverables
Conduct root cause analysis of product or process deviations or failures
Clear communication of learnings and educate other team members on methods and analytical approaches

Requirements

What you’ll need

BS Degree (Mechanical, Biomedical, Chemical Engineering or Materials Science and Engineering) or closely related disciplines
6+ years of experience as a product design/development engineer in the medical device or pharmaceutical industries or related experience
Experience with developing products or implementing product changes through a structured, phase-gated, product development process
Demonstrated experience with all phases of the Design Control process
Demonstrated experience in a technical, product development role on a cross-functional team, leadership role preferred
Understanding of medical device product development risk management methodologies
Possesses expertise in statistical analysis (Minitab, Crystal Ball, etc), analytical tools (e.g. FEA), benchtop testing (e.g. Zwick, fixture design) and experience in root cause analysis/investigation
Strong team building and collaboration skills across the organization.
Knowledge of performance and regulatory compliance (EU and FDA) requirements of medical device and combination products

Benefits

Comp & perks

Health benefits including medical, prescription drug, dental, and vision coverage
Paid vacation and holidays
Paid leaves
Qualified retirement program [401(k) plan]
Short-term incentive bonus opportunity
Eligibility to participate in equity-based long-term incentive program