Senior Design Assurance Engineer at Abbott

Plymouth, Minnesota, United States

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Healthcare, Medical DevicesIndustries

Requirements

Critical thinker who challenges the status quo and finds optimal solutions
Collaborator who listens to ideas, shares thoughts, and works with teams to advance the business
Problem solver who tackles complex problems using first principles and sound technical practices
Communicator who effectively conveys project progress, data analysis, and conclusions to diverse stakeholders
Responsible individual who owns deliverables, sees activities through to completion, and takes accountability for results
Experience in multidisciplinary product development teams, particularly in Design Controls for medical devices like ablation and diagnostic catheters
Expertise in design verification/validation strategies, technical analysis of requirements/specifications, and control strategies
Knowledge of proper verification techniques (inspection, demonstration, test, etc.), design characterization, and applied statistics
Ability to support design test/inspection method development and validation
Familiarity with Design History File (DHF) integrity, regulatory/standards compliance, audits, and product re-certifications

Responsibilities

Lead and implement complex development projects, including quality improvement initiatives
Set strategies for cross-functional teams and drive compliant, efficient solutions to complex problems
Execute holistic and strategic Design Verification/Validation strategies, emphasizing technical analysis of requirements/specifications/control strategy, efficient validation/verification execution, alignment of design outputs to production/process controls, and proper verification techniques
Lead design characterization activities for development projects
Influence design and verification decisions using applied statistics
Support design test and inspection method development, and lead method validation activities
Ensure DHF content integrity, completeness, and regulatory/standards compliance; communicate and resolve gaps collaboratively
Support internal/external audit responses and on-time product re-certifications
Support establishment of objective, measurable, discrete, and verifiable customer and product requirements
Provide development support in multidisciplinary teams, overseeing projects from concept to launch in all phases of Design Controls, with focus on ablation and diagnostic catheters

Skills

Design Assurance

Risk Management

FDA Regulations

ISO 13485

Medical Device Development

Electrophysiology

Product Compliance

Quality Engineering

Verification

Validation

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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