Senior Engineer I, Device Development

AstraZeneca

Development Engineer with 6+ years in device development, focusing on combination products. Supporting technical projects and collaborating across functions in the organization.

Posted 6/5/2026full-timeBoston • Maryland, Massachusetts • 🇺🇸 United StatesSenior💰 $97,000 - $146,000 per yearWebsite

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Hard Skills

product designproduct developmentDesign Control processrisk management methodologiesstatistical analysisanalytical toolsbenchtop testingroot cause analysis

Soft Skills

technical SMEcross-functional collaborationproject management

Tools & Technologies

MinitabCrystal BallFEAZwick

Industry Keywords

medical devicepharmaceuticalregulatory complianceEU requirementsFDA requirementscombination products

About the role

Key responsibilities & impact

Serve as the technical SME/project engineer supporting the development of combination products
Interact with multiple functions and functional teams including Device Quality, Regulatory Affairs, Clinical, Global Technical Operations (GTO), and Alexion Dublin Manufacturing Facility (ADMF)
Manage facets of technical development including interactions with suppliers, CMOs, technology vendors and/or internal cross-functional teams
Oversee the characterization and design verification testing
Author technical documentation in support of the development process

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
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
Knowledge of performance and regulatory compliance (EU and FDA) requirements of medical device and combination products

Benefits

Comp & perks

short-term incentive bonus opportunity
eligibility to participate in equity-based long-term incentive program
retirement contribution
qualified retirement program [401(k) plan]
paid vacation and holidays
paid leaves
health benefits including medical, prescription drug, dental, and vision coverage