Development Quality Engineer at Abbott

Santa Clara, California, United States

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Not SpecifiedCompensation

Mid-level (3 to 4 years)Experience Level

Full TimeJob Type

UnknownVisa

Healthcare, Medical DevicesIndustries

Requirements

Strong collaborative partnership skills with cross-functional teams to protect patient/user safety and meet business needs
Ability to lead completion of design control deliverables for new product development of novel, non-invasive mitral valve replacement technology

Responsibilities

Lead on-time completion of Design Control deliverables
Create and ensure on-time execution of Quality Plans for internal development, OEM-based, and design change projects
Support Design Verification and Validation planning and execution, including study planning, test method and protocol review, active cross-functional root-cause analysis investigation and resolution activities
Lead Risk Management activities, including analyzing field data to support new product development, and supporting Failure Mode Effects Analysis
Support design test and inspection method development, and lead method validation activities
Ensure Device History File (DHF) content completion, integrity, and regulatory & standards compliance; collaboratively identifying, communicating and resolving gaps
Support manufacturing process development and qualification for new product development and product changes
Support internal and external audit responses and on-time product re-certifications
Support and ensure the establishment of objective, measurable, discrete, and verifiable customer and product requirements
Support and ensure objective component specification definitions, supplied component sampling plan development, and vendor qualifications
Support the development and review of biocompatibility and sterilization validations
Support R&D product builds for bench testing, animal lab, and clinical activities
Complete Document Change Request Reviews in a timely and objective manner
Participate in Corrective Action/Preventive Action (CAPA) and Nonconforming Reports (NCR) processes including the investigation of failures or deviations, as required; develop and lead other team members
Support all Divisional initiatives; additional duties may be identified by functional management based on current project/business objectives

Skills

Quality Engineering

Quality Systems

Product Compliance

Risk Management

Regulatory Compliance

Medical Devices

Cross-Functional Collaboration

Structural Heart

Abbott

Healthcare solutions in diagnostics and devices

About Abbott

Abbott Laboratories focuses on improving health through various medical technologies and health solutions. The company operates in areas such as cardiovascular health, diabetes management, diagnostic testing, nutrition, and neuromodulation for chronic pain and movement disorders. Abbott's products include advanced medical devices and diagnostic tests that help healthcare professionals and patients manage health conditions effectively. For example, their cardiovascular technologies assist in heart health management, while diabetes care products enable accurate glucose monitoring without painful fingersticks. Unlike many competitors, Abbott emphasizes accessibility and affordability in its offerings, aiming to make life-changing technologies available to a broader audience. The company's goal is to positively impact global health and well-being, supported by a commitment to sustainability and a 2030 Sustainability Plan.

Lake Bluff, IllinoisHeadquarters

1888Year Founded

IPOCompany Stage

HealthcareIndustries

10,001+Employees

Risks

Departure of key leader Dr. Adamson may affect Abbott's Heart Failure division.

Integration challenges with Medtronic could impact glucose monitor-insulin pump rollout.

Thermo Fisher's microfluidics expansion may increase competition for Abbott.

Differentiation

Abbott integrates continuous glucose monitoring with automated insulin delivery systems.

Abbott's microfluidic devices streamline diagnostic processes efficiently.

Abbott's neuromodulation products target specific nervous system areas for chronic pain relief.

Upsides

Microfluidic technology offers cost-effective solutions in diagnostics.

Strategic partnerships like Abbott-Medtronic enhance product offerings and market reach.

Significant investments indicate strong market confidence in Abbott's healthcare solutions.

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