Risk Management Engineer II at Abbott

Plymouth, Minnesota, United States

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Not SpecifiedCompensation

Mid-level (3 to 4 years)Experience Level

Full TimeJob Type

UnknownVisa

Healthcare, Medical DevicesIndustries

Requirements

Bachelor’s degree in Engineering or a technical field
3+ years of experience
Previous design quality engineering experience and demonstrated use of quality tools/methodologies
Experience working in a cross-division or enterprise-wide business model

Responsibilities

Support/Execute Risk Management Plan for product development, including supporting system/product risk management planning
Assist in requirements development to ensure quality and linkage to the risk management file
Support system hazard analysis and risk assessments (FTAs, FMEAs)
Analyze and incorporate legacy inputs; coordinate cybersecurity risks with patient safety implications
Ensure traceability among hazards, risks, analyses, evaluations, controls, and verification of control effectiveness
Contribute to system/product risk management reports
Serve as the point of contact for tracking and responding to post-market signals (event-based and periodic)
Lead updates to the risk management file, including annual updates
Conduct complaint analysis and develop action plans
Provide backroom support for audits
Develop proficiency in primary risk assessment tools (e.g., FMEA, FTA)
Identify and support improvements to risk management processes and infrastructure
Support changes driven by external regulations, standards, guidance, or internal Abbott Quality Policies
Assist with CAPA efforts linked to risk management

Skills

Risk Management

Quality Systems

Regulatory Compliance

Medical Devices

Post-Market Surveillance

Design Engineering

Clinical Collaboration

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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