Design Assurance Engineer

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

Authority:

• You have authority to stop the job if you feel there is an unsafe work practice which could result in a risk of injury, have an environmental impact or risk to equipment and other personnel.

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

At Atlantach we offer a highly competitive benefits package, including: 

• Competitive salary and holiday entitlements. 
• Flexible hours and remote working options; role dependant. 
• Healthcare Insurance cover. 
• Further education financial assistance. 
• Access to a personal financial advisor. 
• Bike to work scheme. 
• Employee engagement and company-wide events. 

Atlantach Technical Services is an Equal Opportunities Employer