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Senior Design Assurance Engineer

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Abbott Laboratories

7d ago

  • Job
    Full-time
    Senior Level
  • Engineering
    Healthcare
  • Galway

AI generated summary

  • You need a degree in Science, Engineering, or Technology, 5 years in Quality Engineering/Design Assurance, strong data analysis, communication, and presentation skills, and experience in diverse environments.
  • You will ensure compliance with design controls, conduct technical reviews, lead audits, develop training, support R&D, manage a team, and promote regulatory awareness across the organization.

Requirements

  • Primary Degree level qualification in Science, Engineering or Technology, plus 5 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 would be beneficial.
  • Excellent data analysis skills.
  • Proven ability to work well as part of a team and on own.
  • Excellent communication skills to support virtual project requirements.
  • Clear demonstrated experience in working in a diverse cultural environment.
  • Excellent presentation skills to facilitate communication throughout the organisation. In addition, excellent use of virtual communication technology is required for effective workshop leadership and change management.
  • Travel pending company policy, global and country regulations to Asia and Europe.

Responsibilities

  • Promotes the awareness of regulatory and customer requirements throughout the organization.
  • Review and 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.
  • Development 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.
  • Design Control Support for audits including Abbott Corporate Audits and external Regulatory/ Governing Body audits (e.g. FDA/ WHO). Take the lead and front the team’s participation in audits.
  • Manage a team of Design Assurance Engineers are the organisation grows and develops.
  • Ability to work is a matrix organisation where project deliverables are accountable to the Program/ Workstream Leader.

FAQs

What is the duration of the position?

The position is a 12-month fixed-term contract (FTC).

What qualifications are required for this role?

A primary degree level qualification in Science, Engineering, or Technology, plus 5 years of Quality Engineering/Design Assurance work experience within a regulated environment (ISO13485/FDA) is required.

Is experience in Medical Device Risk Management beneficial?

Yes, formal training in Medical Device Risk Management, Process Validation, Software Validation, and problem solving would be beneficial.

What skills are essential for this position?

Excellent data analysis skills, communication skills, presentation skills, and the ability to work both independently and as part of a team are essential.

Will I be required to travel in this role?

Yes, travel may be necessary depending on company policy and global and country regulations, particularly to Asia and Europe.

What type of team will I be working with?

You will be working with a diverse team across various functions including R&D, Marketing, QA, RA, Clinical Operations, and Manufacturing.

Is there a focus on training in this role?

Yes, the role involves the development of effective training collateral to ensure compliance with design control policies within the organization.

What will be my primary responsibilities?

Your primary responsibilities will include promoting regulatory awareness, reviewing and remediating design control procedures, supporting the design control process in new product development, and providing design assurance expertise.

How will my performance be measured?

Your performance will be measured based on the successful implementation of design controls, compliance with regulations, and effective collaboration with cross-functional teams.

Do I need to have experience in a matrix organization?

Yes, experience in working within a matrix organization is important, as project deliverables will be accountable to the Program/Workstream Leader.

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Abbott Laboratories

Science & Healthcare
Industry
10,001+
Employees

Mission & Purpose

At Abbott, we’re dedicated to helping people live more fully, in everything we do. We’re creating the future of healthcare through life-changing technologies that make you healthier and stronger, quickly identify when you have a medical need, and treat conditions to help you get back to doing what you love. With headquarters in north suburban Chicago, Abbott serves people in more than 160 countries with leading medical devices, diagnostics, nutrition products and branded generic medicines. More than 115,000 of us are helping millions of people to live better and healthier, every day around the world. Our employees do work that matters as part of a global community that supports them with career development opportunities and locally competitive benefits. Mission: We help people live better and healthier with our life-changing technologies. We're revolutionizing health with the most personal technologies, empowering people with the data and knowledge they need to help them live longer and better.