Senior Design Assurance Engineer

  • Location
    Galway, Galway
  • Category
    Engineering - Design
  • Job type
  • External Reference

The role
We are currently recruiting for a Senior Design Assurance Engineer on behalf of the world's largest medical device company! This company values what makes you unique and wants you to join their team who think differently to solve problems, make progress, and deliver meaningful innovations.

This role is a full-time, permanent role that will be based in Galway but offers the opportunity for remote working where you would be needed on site 2/3 days a month. Additionally, this company is offering an amazing starting salary and benefits package.

The successful candidate will join the Coronary and Renal Denervation Design Assurance Team, who's purpose is to increase product development process rigor to ensure robust understanding of designs, documentation of compliance to requirements and timely, high-quality product launches that satisfy patient needs and reduce customer complaint rates.

Key Responsibilities
*Apply knowledge of design control principles and quality engineering techniques throughout the product development process.
*Identify and manage risk using a FMECA and/or other risk management tools.
*Ability to independently lead investigations to identify system/product failures, hazards, hazardous situations, and harms.
*Establish verification and validation strategies with R&D and Regulatory to assure an efficient approval path.
*Develop master test plans that encompass design verification, design validation and process validation activities that are sufficient to meet regulatory requirements and quality objectives.
*Provide input to design and manufacturing deliverables including material specifications, drawings, inspection procedures, and manufacturing procedures, to ensure that the resulting products can be adequately manufactured and tested.
*Develops, coordinates and conducts technical reliability studies and evaluations of engineering design concepts and design of experiments (DOE) constructs.
*Apply understanding of anatomy & physiology with engineering knowledge in materials and processes to come up with designs.
*Interface effectively and build relationships with team members, other staff and key technology and component suppliers, both locally and globally.
*Works independently to plan and schedule own activities necessary to meet timelines.
*Develops, modifies, applies and maintains quality standards and protocol for processing materials into partially finished or finished materials product.
*Collaborates with engineering and manufacturing functions to ensure quality standards are in place.
*Devises and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment.
*Designs or specifies inspection and testing mechanisms and equipment; conducts quality assurance tests; and performs statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications.
*Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements.
*May specialize in the areas of design, incoming material, production control, product evaluation and reliability, inventory control and/or research and development as they apply to product or process quality
Required Skills and Experience
*Requires advanced knowledge of job area combining breadth and depth, typically obtained through advanced education combined with experience.
May have practical knowledge of project management.
*Requires a Bachelors Degree in a relevant area and minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience.
*You are a dynamic team player, can work effectively and proactively on cross-functional teams with good communication and technical writing skills.
*Initiates and Leads Change, Collaborates and Creates Alignment, Drives Accountability and Thinks Critically and Makes Sound Decisions.

Adecco Ireland is acting as an Employment Agency in relation to this vacancy.

Please apply with your CV to: Niall Ramsbottom