Design Assurance Engineer I / II

Location:

Galway, Connaught, Ireland

Salary:

Competitive

Type:

Permanent

Main Industry:

Search Finance, Banking & Insurance Jobs

Other Industries & Skills:

Manufacturing

Advertiser:

Boston Scientific

Job ID:

130324099

Posted On:

06 April 2024

Our Mission:

At Boston Scientific Galway, we are dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world.

We work collaboratively to solve healthcare’s toughest problems by developing solutions that matter most to those suffering from debilitating and life-threatening conditions and to the healthcare professionals who provide their care. 

We are seeking a Design Assurance Engineer I/II on a permanent basis to join us on our mission.

Job Purpose

We have an excellent opportunity for a Design Assurance Engineer I/II to join our team in Boston Scientific in a permanent role. As part of the Design Assurance team, a key role will be to demonstrate commitment to the Quality Policy (patient safety and product quality) by executing sound quality practices and maintaining an effective quality system. The team member will support the application of Design Controls in projects focusing on quality, compliance, material continuity, and Value Improvement Projects (VIPs), ensuring that all design changes are compliant to associated regulations and procedures. In addition, the team member will support Post Market Surveillance activities such as monitoring product performance in the field and monthly signals, completing periodic safety update reports and improving the monitoring and trending processes.

The Design Assurance team supports drug eluting therapies such as drug-coated stents, cutting balloons and drug-coated balloons for Interventional Cardiology.

Key Responsibilities of the Role:

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-Effective understanding of requirements and procedures that govern medical device Design Control.
-Understanding of Design Assurance requirements to ensure project deliverables comply with all internal and regulatory requirements.
-Provide design quality support in the resolution of PIRs, CAPAs, NCEPs, and regulatory requirement changes.
-Interface with R&D, Regulatory Affairs, Clinical Risk, Medical Safety, Operations and Post Market Teams (CIS, CMC and Trending) in a project team environment to provide technical and quality systems input.
-Development and execution of protocols and reports as part of Design Verification and Stability activities through the life cycle of the product.
-Development and execution of Periodic Safety Update Reports (PSUR) for the IC products
-Draws conclusions and makes appropriate decisions from test data using excellent analytical and problem-solving abilities.
-Create and develop monitoring criteria to measure field performance.
-Monitor monthly product performance and investigate field complaint signals.
-Ownership of design change projects including scoping, assessment and implementation.
-Drive updates to documents within the Risk Management File, such as the Hazard Analysis, Task Analysis and Design FMEA.
-Ensure and maintain regulatory compliance with appropriate guidance documents such as company SOP/WI’s and EU/FDA/Global guidelines.
-Is enthusiastic and fully motivated to develop their career, to demonstrate best practices in line with the department and site objectives and continually seeks to drive improvements in product and process quality.
 

Qualifications and Experience:

-Level 8 Bachelors Degree (240 credits) qualification in a STEM discipline 
-Min 2 years industry experience; Design Assurance experience would be an advantage.
-Experience in areas such as Post Market Surveillance, complaints, design control, risk management, design and process change, and standards compliance (to regulatory requirements) would be an advantage.
-Strong technical capabilities, communication skills, teamwork abilities and initiative
-Proven ability to work well both as part of a team and individually.
 

At Boston Scientific, we recognise that nurturing a diverse and inclusive workplace helps us be more innovative. It is essential in advancing science for life and improving patient health. We stand for inclusion, equality, and opportunity for all. By embracing the richness of our unique backgrounds and perspectives, we create a better, more rewarding place for our employees to work and reflect the patients, customers, and communities we serve. Boston Scientific is proud to be an equal opportunity and affirmative action employer. Boston Scientific is committed to providing reasonable accommodations for applicants and employees with a disability. Should you require a reasonable accommodation during the recruitment process, please let us know.

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