Design Assurance Engineer - IVDR at Abbott

Galway, County Galway, Ireland

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Not SpecifiedCompensation

Mid-level (3 to 4 years), Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Healthcare, Medical Devices, DiagnosticsIndustries

Requirements

Primary Degree level qualification in Science, Engineering or Technology
2-3 years of Quality Engineering/Design Assurance work experience within a regulated environment (ISO13485/FDA)
Formal training in Medical Device Risk Management, Process Validation, Software Validation and problem Solving (beneficial)
Excellent data analysis skills
Proven ability to work in a matrix organisation where project deliverables are accountable to the Program/Workstream Leader

Responsibilities

Promotes the awareness of regulatory and customer requirements throughout the organization
Remediation of current Design Control procedures and practices across sites to standardise to “best in class” design controls
Liaise with quality systems and regulatory affairs personnel within the Business Unit to ensure team’s compliance and to drive alignment and harmonization
Deployment of effective training collateral to ensure compliance to design control policies with the Core Teams, Extended teams and relevant functions within the Business Unit
Embed Design Assurance in all stages of the design concept and feasibility to support R&D through specification setting, test development and provision of statistical sampling to ensure robust prototypes and design at design freeze
Support new test development and appropriate test method validation
Provision of on-going risk management, design control, quality systems and overall design assurance expertise and leadership to the Project Core and Extended teams
Perform technical reviews of design documentation and labelling, attend at design reviews, coordinate and facilitate completion and update of design risk management documentation and acts as independent reviewer for all design activities including design changes
Escalate where appropriate design control concerns/issues in a timely manner to ensure project schedule maintenance
Design Control Support for audits including Abbott Corporate Audits and external Regulatory/Governing Body audits (e.g. FDA/WHO)

Skills

Key technologies and capabilities for this role

Design AssuranceDesign ControlIVDRNPILateral Flow Diagnostic DevicesR&DQARARegulatory Compliance

Questions & Answers

Common questions about this position

What is the employment type for this Design Assurance Engineer position?

This is a full-time position, specifically a 12-month fixed-term contract (FTC).

Is this Design Assurance Engineer role remote or office-based?

This information is not specified in the job description.

What key skills and expertise are required for the Design Assurance Engineer role?

The role requires expertise in design control, risk management, quality systems, regulatory compliance, test method validation, and statistical sampling, along with the ability to provide leadership to cross-functional teams.

What is the team structure like for this position at Abbott?

The role is part of the global Design Assurance team for the IDEM Infectious Diseases Emerging Market Business Unit, supporting cross-functional Core Teams and Extended Teams including R&D, Marketing, QA, RA, Clinical Operations, and Manufacturing across Europe, Asia, and the US.

What makes a strong candidate for this Design Assurance Engineer position?

Strong candidates will have experience in design controls, regulatory compliance, risk management, and cross-functional leadership, with the ability to standardize best practices, train teams, and support NPI projects from ideation to launch.

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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