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About AbbVie

AbbVie’s mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.

Senior Engineer, Device R&D Quality

Israel Req ID 2106161 Category Quality Assurance Division AbbVie

We are recruiting for a Senior Engineer, Device R&D Quality will support the development of medical devices and/or device components of combination products by providing direction on applicable design control, human factors/usability engineering, and risk management processes. This position will engage with all areas involved in the product development process and provide direction and consultation assuring the design control process is effectively established, executed, and maintained. This position will participate in product risk assessment efforts, including hazard analysis and failure mode effect analysis, and development of the risk management plans and reports.

In this role, you will:

Technical Support

  • Provides quality system methodology guidance, support, and review for medical device and combination products throughout the design and development and change control processes.
  • Actively participates on cross-functional design teams assessing design documentation for quality characteristics, including: product requirements, risk management, verification and validation, manufacturability, serviceability, biocompatibility, human factors/usability, sterilization, packaging, distribution, and reliability.
  • Works with product development engineering and manufacturing engineering to translate design requirements into manufacturing requirements to achieve design for manufacturability.
  • Serves as a technical resource for issue investigations to guide root cause analysis / corrective action development.

Project/Process Management

  • Provides clear and regular technical and administrative direction to the cross functional project team. Considers broad perspective of company, regulatory, and site policies and procedures.
  • Leads teams with and without direct authority.
  • Facilitates and leads design control and risk management activities. Accountable for risk management file deliverable and DHF compliance.
  • Partners with site quality team to transfer device documentation and knowledge.

Quality Systems

  • Ensures that product development projects and changes to existing products are conducted in compliance with the FDA Quality System Regulation, ISO 13485 Regulations, EU MDR, and other applicable standards.
  • Maintains expertise in both current and emerging requirements and quality trends as they relate to Pharmaceuticals and Medical Device/Combination Products worldwide.
  • Interprets regulations and trends and recommends/executes changes to quality standards to ensure conformance and continuous improvement.
  • Provides project success information to management reviews to evaluate efficacy of the risk management process.

Education and Experience

  • Minimum of a BS in Engineering or Scientific discipline; MS preferred
  • 10+ years’ experience working in the Medical Device industry
  • Proven expertise with interpreting, applying, and leading others in compliance with 21 CFR Part 820 Quality System Regulation, ISO 13485 Quality Standard, ICH Q9 Guidance for Industry – Quality Risk Management, 21 CFR 4 Regulation of Combination Products, SOR 98- 282 Canadian Medical Device Regulation, ISO 14971 Risk Management Standard, MDD, MDR, IEC/EN 62366 Application of Usability Engineering to Medical Devices, and ANSI HE75 Human Factors Engineering in Design of Medical Devices
  • Skilled in requirements analysis, including testable and measurable specifications
  • Familiar with reliability analysis and test methods and test method validation
  • Fluent English and Hebrew

Apply today to join our team!

Travel: Yes, 10 % of the Time
Job Type: Experienced
Schedule: Full-time

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