• Ireland

Job Description:

Purpose and Passion Comprehensive Benefits Life-Work Integration Community Career Growth

At Boston Scientific, you will find a collaborative culture driven by a passion for innovation that keeps us connected on the most essential level With determination, imagination and a deep caring for human life, were solving some of the most important healthcare industry challenges Together, were one global team committed to making a difference in peoples lives around the world This is a place where you can find a career with meaningful purposeimproving lives through your lifes work

We are currently looking for a Senior Design Assurance Engineer to join our Galway site on a permanent basis

Job Purpose Fulfil the quality assurance responsibilities of BSCs product development and related sustaining engineering activities, including

Creating and maintaining a culture of commitment to improving patient safety, customer satisfaction and product quality in BSC
Assuring compliance by interpreting and fulfilling regulatory requirements applicable to the medical device industry
Promoting and effecting compliance to BSCs quality, business and health & safety systems and market/legal regulations
Analysing, reducing and managing risks associated with the design, use and manufacture of BSC devices
Providing expertise in BSCs product development systems to project teams
Supervising, leading and coaching members of the design assurance department

Key Responsibilities


Interfaces with R&D, Regulatory Affairs, Clinical, Marketing, Process Development and Manufacturing functions in a project team environment
Liaise with corporate and divisional quality systems and regulatory affairs personnel in ensuring compliance of product development activities to internal and external requirements
Monitor the release and updates of quality policies to ensure compliance with Product Development needs and communication of this information to the Product Development Group
Continually seeks to drive improvements in product and process quality
Implement, maintain and update procedures that ensure that R&D documentation constantly meets BSCs Product Development Process and Design Control requirements
Provides the quality/independent review at defined design reviews, project design plans, risk management, design verification/validation protocols and reports, for new development projects as well as design/process changes to existing product lines


Provides regulatory compliance, risk management, design control and quality systems expertise to the team
Identifies and resolves complex exceptions to work assignments
Summarises, analyses, draws conclusions and makes appropriate decisions from test results or other process related findings
Fully conversant with verification/validation techniques, risk management, statistical techniques and associated regulatory requirements
Build Quality into all aspects of work by maintaining compliance to all quality requirements
Keeps up to date on all ISO/EN/FDA/MDD and other Product Development related regulatory requirements and relay this information to the Product Development group


Is an active member of the project team, formulating strategy and leading execution on quality deliverables as outlined in BSCs Product Development Process (PDP), Recertification, Risk Management and Design Control SOPs
Co-ordination of team activities in line with departmental objectives and project goals
Supervision and development of staff reporting to them in line with departmental and project goals
Uses opportunities in project assignments to develop other team members
Coaches others in analysis and decision making A source of technical guidance to Quality Engineer II, Quality Engineer I, Graduate Quality Engineer, Technician and Inspection staff
Is perceived as a proponent of change within the project/department and willing to challenge the status quo to create best in class
Is a good team member, committed to the projects success and fully motivated to achieve and demonstrate best practices in line with the department and site objectives
Provide guidance on design control requirements to PDP/TDP teams and sustaining engineering activities in line with BSC policies and procedures

Qualifications and Experience

HETAC Level 8 in a relevant STEM discipline with a minimum of 5 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
Knowledge & understanding of EN ISO 5840-3 is essential
Material knowledge of nitinol and any experience with testing of nitinol is desirable
Material knowledge of animal origin (bovine or porcine) is desirable
Basic knowledge/understanding of valve testing/kinematics
Basic knowledge of Finite Element Analysis

About us

As a global medical technology leader for more than 35 years, our mission at Boston Scientific (NYSE BSX) is to transform lives through innovative medical solutions that improve the health of patients If youre looking to truly make a difference to people both around the world and around the corner, theres no better place to make it happen

Requisition ID 447719


Job Segment Medical, Manufacturing Engineer, Engineer, Product Development, Design Engineer, Healthcare, Engineering, Research

Profile Summary:

Employment Type : Full Time
Eligibility : Any Graduate
Industry : Others - other Industry
Functional Area : Production/Manufacturing/Maintenance/Packaging
Role : Production/Manufacturi ng/Maintenance
Salary : As per Industry Standards
Deadline : 17th Mar 2020

Key Skills:

Company Profile:


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