Design Assurance Engineer

Galway
Posted 3 weeks ago

About us

Atlantach Technical Services is an Engineering solutions company specialising in the project management, construction and commissioning market in Ireland and the USA. We are a trusted partner to leading blue chip companies across many sectors with project work spanning semiconductor, automotive, MedTech and Data Centre – just some of the focus areas we work in.

Join Our team

Currently, we are looking for like-minded professionals to join our team and are hiring a Design Assurance Engineer to support our very high-profile Medical Device client in Co. Galway.

Job Purpose

Fulfil the quality assurance responsibilities of new product development and post market (commercial product) support, including:

  • Demonstrating and promoting a commitment to improving patient safety, customer satisfaction and product quality
  •  Understanding and complying to quality, business, health & safety systems and market/legal regulations governing the quality systems.
  • Removing or mitigating against risks associated with the design, use and manufacture of devices.
  • Ensuring commitment to training requirements and understanding and complying with all regulations governing their work.

Duties and Responsibilities:

  • Completes work assignments under limited supervision/guidance.
  •  Interfaces with R&D, Regulatory Affairs, Clinical, Medical Safety, Complaints Management Centres and Post Market Quality Assurance team environment providing technical and quality systems input.
  • Familiarity with requirements and procedures that govern medical device Design Control, Risk Management and Post Market Surveillance.
  • Identifies and resolves complex exceptions to work assignments.
  • Seeks to support improvements in product and process quality.
  •  Builds Quality into all aspects of work by maintaining compliance to all quality requirements.
  • Excellent interpersonal and communication skills with good leadership abilities.
  • Provides both quality and technical input to ongoing product development and post market commercial product activities.
  • Experienced in post market (complaints) support, risk management, design and process change, standards compliance (to regulatory requirements).
  • Provides design quality support in the resolution of PIRs, complaints investigation, CAPAs, VIPs, regulatory requirement changes.
  • Excellent analytical and problem solving abilities. Analyses, draws conclusions and makes appropriate decisions from risk management activities and test data

Requirements:

  • HETAC Level 8 in a STEM discipline with a minimum of 3-4 years’ experience in a similar role.
  • Good technical capabilities, communication skills, teamwork abilities and initiative.
  • Proven ability to work well as part of a team & on own with minimum supervision
  • Good verbal and written communication skills
  • Strong analytical skills
  • Comfortable working independently and as part of a cross-functional team
  • Prior medical device industry experience

Atlantach Technical Services is an Equal Opportunities Employer

Job Features

Job CategoryEngineering

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