Senior Hardware-Software Device Engineer I or II, Combination Product Development, R&D
3 days ago
AbbVie is a leading biopharmaceutical company dedicated to discovering and delivering innovative medicines and solutions that address serious health issues. We are seeking a highly skilled Senior Device Engineer to join our Combination Product Development team in R&D.
Key Responsibilities:- Contribute to the development of electromechanical devices and combination products for various phases of clinical studies.
- Collaborate with cross-functional colleagues in operations as programs transition to commercial development.
- Develop and execute engineering confidence test plans and design margin assessment.
- Define and execute user interface and translate user workflow to software requirements.
- Understand and support system reliability studies from electrical hardware perspective.
- Plan for design outputs and ownership of design output reviews.
- Design verification support including design and execution of tests using automated test tools and manual test development.
- Assist the development team in troubleshooting and solving issues.
- Assess compliance to international standards and regulatory requirements for software and medical devices.
- Collaborate with external global manufacturing and development partners.
- BS in Software Engineering, Computer Science, Electrical Engineering, or Biomedical Engineering with 8+ years of experience or MS with 6+ years of experience.
- Experience in device development, medical device, pharmaceutical, or other regulated industries.
- Familiarity with electrical schematics and system design.
- Detailed understanding of principles and practice of Design Controls, Medical Device Software Lifecycle, and Risk Management.
- Strong communication skills and ability to influence without direct authority.
- Strong device design and analytical skills.
- Proficiency in tolerance analysis and descriptive statistics.
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