AstraZeneca

2 days ago

Engineer III, Device Development

✓ Verified Job

Canonical indexed version, validated from employer's careers page.

Source: Company careers pageValidated by: Fursa AI

Last checked: 17 hours agoStatus: Live

Job Summary

Serve as an Engineer III for device development human factors/usability engineering within the Alexion Device Development organization. Lead human factors activities for combination product design through feasibility, clinical development, registration, and post-market lifecycle management, including formative studies, summative validation, usability/user-interface specifications, and use-related risk management. Partner across Device Development, Clinical, Commercial/Marketing, Quality, and Regulatory while coordinating external human factors vendors and ensuring compliance with applicable quality and regulatory requirements.

Location: Boston

Workplace: Onsite

Employment Type: Full time

Job Function: Product Management

Seniority: Mid level

Key Responsibilities

•Lead and support human factors and usability engineering activities for combination product design and development from feasibility through clinical development, registration, and post-market.
•Support strategy development for human factors/usability engineering activities, from formative studies through final HF validation.
•Conduct design validation work including summative human factors studies (protocol development, execution, and reporting).
•Develop user need identification and user interface specifications, and provide input to use-related risk management (known use problem analysis, hazard analysis, use-related risks).
•Collaborate with external human factors vendors and communicate across departments to ensure compliance with quality and applicable regulatory requirements.

Pay and Benefits

Salary: USD 101,643.2 - 133,406.7 annually

Equity and Bonus:Equity

Perks:Health InsuranceDentalVisionPaid Leave

Key Requirements

•Experience in human factors engineering and exposure to design and development of medical device and combination products.
•Experience in design control activities.
•Ability to manage external human factors firms (vendors) for formative or summative human factors studies.
•Knowledge of human factors/usability engineering and safety, performance, and regulatory compliance requirements for medical device and combination products.
•Strong communication and collaboration skills, including writing internal reports, project summaries, and internal/external presentations.

Experience:Medical devicesCombination products

Education:Bachelor's in Biomedical, Chemical, Mechanical, Electrical Engineering or Human Factors

Skills:CommunicationCollaborationRisk managementProject reportingVendor management

Tech Stack:Human factors engineeringUsability engineeringDesign controlIEC 62366FDA HF guidancesEU Regulation 2017/745 (MDR)Hazard analysisUse-related risk managementSummative human factors studyFormative studiesKnown use problem analysis

Company Brief

AstraZeneca

Global biopharmaceutical company discovering, developing and commercializing prescription medicines across oncology, cardiovascular, renal & metabolism, respiratory, and immunology, focused on innovative therapies and vaccines to improve patient outcomes worldwide.

Industry: Pharmaceuticals

Company Size: Enterprise (1,001+ employees)

Revenue: USD 1B+

Growth: Public Company

Valuation: Public Company (Market Cap in USD)

Funding: IPO / Publicly Listed

Headquarters: Cambridge, United Kingdom

Founded: 1999

Glassdoor: 3.8

Website LinkedIn

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AstraZeneca

2 days ago

Engineer III, Device Development

✓ Verified Job

Canonical indexed version, validated from employer's careers page.

Source: Company careers pageValidated by: Fursa AI

Last checked: 17 hours agoStatus: Live

Job Summary

Location: Boston

Workplace: Onsite

Employment Type: Full time

Job Function: Product Management

Seniority: Mid level

Key Responsibilities

•Lead and support human factors and usability engineering activities for combination product design and development from feasibility through clinical development, registration, and post-market.
•Support strategy development for human factors/usability engineering activities, from formative studies through final HF validation.
•Conduct design validation work including summative human factors studies (protocol development, execution, and reporting).
•Develop user need identification and user interface specifications, and provide input to use-related risk management (known use problem analysis, hazard analysis, use-related risks).
•Collaborate with external human factors vendors and communicate across departments to ensure compliance with quality and applicable regulatory requirements.

Pay and Benefits

Salary: USD 101,643.2 - 133,406.7 annually

Equity and Bonus:Equity

Perks:Health InsuranceDentalVisionPaid Leave

Key Requirements

•Experience in human factors engineering and exposure to design and development of medical device and combination products.
•Experience in design control activities.
•Ability to manage external human factors firms (vendors) for formative or summative human factors studies.
•Knowledge of human factors/usability engineering and safety, performance, and regulatory compliance requirements for medical device and combination products.
•Strong communication and collaboration skills, including writing internal reports, project summaries, and internal/external presentations.

Experience:Medical devicesCombination products

Education:Bachelor's in Biomedical, Chemical, Mechanical, Electrical Engineering or Human Factors

Skills:CommunicationCollaborationRisk managementProject reportingVendor management

Company Brief

AstraZeneca

Industry: Pharmaceuticals

Company Size: Enterprise (1,001+ employees)

Revenue: USD 1B+

Growth: Public Company

Valuation: Public Company (Market Cap in USD)

Funding: IPO / Publicly Listed

Headquarters: Cambridge, United Kingdom

Founded: 1999

Glassdoor: 3.8

Website LinkedIn