דרושים ב-Boston Scientific ב-Ireland

Advancing possibilities for a brighter tomorrow

Key Responsibilities:

• Implements a staffing plan by identifying resource requirements, writing justifications for additional personnel, obtaining approval for changes, and coordinating the selection process with Human Resources.
• Develops direct reports by securing appropriate training, assigning progressively challenging tasks, applying progressive disciplinary action as appropriate and conducting formal written and verbal performance reviews.
• Monitors daily work operations and provides direction to predominantly nonexempt and entry level staff to achieve unit or departmental goals.
• Interacts with internal and external customers, by meeting regularly, responding to requests and explaining procedures.
• Interprets and executes policies that affect individuals within the assigned organizational unit or department.
• Monitors compliance with company policies and procedures (e.g. compliance with FDA, BSI, EEO regulations etc).
• Develops work schedules for department by assessing priorities, workload and available resources.
• Maintains personnel records (e.g., work schedules, vacation schedules, leaves) and makes or directs modifications in the database to reflect actual changes.
• May perform individual contributor tasks, especially in staff or professional units.

Education & Experience:

• Honours Bachelor Degree (HETAC level 8) in a Business/Engineering or other related discipline.
• Ideally 3 + years experience in a Leadership role within a manufacturing environment.
• Previous experience of leading and managing teams in a manufacturing environment is essential.
• Must be able to demonstrate personal leadership experience and understand the importance of positive employee engagement.
• Have excellent working knowledge of manufacturing and industry “best practice”.
• Have a high level of business awareness, be action oriented complemented by the resilience to achieve challenging objectives.
• Strong interpersonal skills, an innate ability to influence and build relationships at all levels and a driving vision to create an inclusive culture of performance, continuous improvement and development.
• Must be a pro-active self-starter and an excellent communicator with exceptional problem solving skills.

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Job Purpose:

The Senior Regulatory Affairs (RA) Specialist is responsible for activities which lead to and maintain regulatory approval to market devices. Additionally, the Senior RA Specialist is responsible for assessment of device changes for regulatory implications.
This is a hybrid position (in office minimum three days per week) with the flexibility to be located in Cork, Galway or Clonmel. You will have the opportunity to discuss your preferred working location with your Talent Acquisition Specialist.

Key Responsibilities:

• Develop US, EU and international regulatory strategies for approval of medical devices
• Coordinate, compile, and submit U.S. and EU regulatory filings for new and modified products
• Support requests from BSC International Regulatory personnel related to submissions, registrations, and change assessments
• Develop and maintain positive relationships with regulatory body reviewers
• Review Technical and Labelling documentation for inclusion in regulatory filings
• Review product and manufacturing changes for compliance with applicable regulations and impact to regulatory filings
• Represent RA on cross functional projects which may include product development, sustaining changes, and continuous improvement efforts
• Review clinical study protocols and other clinical documentation, and assess clinical study related changes to determine regulatory impact
• Support regulatory audits, as required
• In all actions, demonstrate a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures

Required:

• A minimum of a Level 8 Honours Bachelor's Degree in STEM
• A minimum of 5 years of regulatory affairs or related experience
• Demonstrated experience assessing product and manufacturing changes for compliance with applicable regulations and impact to regulatory filings
• Demonstrated experience authoring/supporting a variety of regulatory submissions for US and EU, such as 510(k)s and MDR Technical Documentation
• Basic computer skills, including experience with the software applications Microsoft Word, Excel, PowerPoint and Adobe Acrobat

Preferred:

• Strong technical, research and problem-solving skills
• Ability to articulate complex ideas clearly both verbally and in writing
• Team player with excellent interpersonal skills
• Demonstrated ability to effectively manage multiple projects and priorities
• Works well in fast-paced cross-functional team environments
• Pharmaceutical and/or Drug/ Device Combination device experience and Clinical expertise an advantage

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ployees with a disability. Should you require a reasonable accommodation during the recruitment process, please email

Job Purpose:

on our, you’ll be the technical driver behind product quality, reliability, and lifecycle improvements across a portfolio that includes laser fiber devices for kidney and bladder stone treatment (lithotripsy) and prostate tissue removal (HoLEP). You’ll lead crossfunctional work that keeps our devices safe, effective and available—so patients get the care they need, when they need it. *Your way forward is our way forward".

Key Responsibilities:

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Job Purpose:

As a Microbiologist II you will conduct data review, provide support and guidance in the areas of cGMP, Regulatory, technical investigations, test method validation and environmental control to both laboratory Technicians and various operations workstreams. They are responsible for ensuring that all testing is carried out in line with all quality system and regulatory requirements.

Key Responsibilities:

• Demonstrate a primary commitment to patient safety and product quality.
• Responsible for maintaining a full understanding and complying with all the regulations governing the quality system (including ISO 17025).
• Ensure all training is completed as per Laboratory Training Program 90188455.
• Co-ordinate and train to ensure compliance to mandatory training requirements.
• Responsible for reviewing all data and associated data reports generated in the laboratory for conformance to specifications.
• Provide technical guidance/trouble shooting in the event of Microbiology related issues.
• Assists in the implementation of new tests, new technology, and improvements to existing tests.
• Perform new equipment qualifications and requalifications as assigned and write related protocols/reports.
• Provide direction to Technician roles and various operations workstreams.
• Attend and represent the Microbiology Laboratory at various meetings and on cross functional project teams as required.
• Support Internal/External Audits and ensures all non-conformances are adhered to in a timely manner.
• Designee for Laboratory Supervisor as required, by overseeing the day to day operation of the Microbiology laboratory.
• Communicates any concerns about work process regarding environmental impact, health or safety issues to their Manager.
• Perform and assist with additional duties as may be directed by the Microbiology supervisor/Manager.
• Compile, Review and Report Environmental metrics; Calculate and review product bioburden alert limits and cleanroom air and surface alert and action limits; Establishes and monitors appropriate Lab Metrics including Management Review support; Review and Assess from a microbiology context all changes that impact product or the cleanroom environment including introduction of new products; Provides technical support on microbiology related issues to various operational departments.

Education & Experience:

• Level 8 Honours Degree in Microbiology or a related Science based discipline.
• 3+ years experience post-graduate in a Regulated Environment

Key Responsibilities:

• The ability to perform failure analysis on electronic test failures to get to root cause to component level for implantable electronic medical devices.
• Using knowledge of standard test software applications, able to work with in-house and external software developers to define and drive improvements and changes to test software applications and systems to improve test yields.
• Work with cross functional groups to improve product quality, lean efficiency’s and test system efficiency’s and reduction in production fallout.
• Performs tests, analyzes data, writes reports and executes validations to medical device standards.
• Excellent data analysis and technical problem-solving skills, utilizing common applications and in-house component and device tracking systems.
• Utilizing good documentation skills complete regulatory submissions using change notice process and procedures.
• Work daily with quality, manufacturing engineering and operations, providing improvement feedback and assisting with resolution of quality and manufacturing issues.

Education & Experience:

• Hons bachelors degree in electrical or electronic engineering or related discipline.
• Minimum of 3 year’s relevant experience.
• Experience in an electronics engineering environment.
• Excellent knowledge in electronics with proven problem-solving abilities and the ability to project manage issues to closure.
• Knowledge of test software applications such as Lab View and C or C++
• Experience in validations in the medical device industry would be an advantage.
• Very strong communication skills are a key requirement.

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Job Purpose:

As a Senior R&D Engineer, you will be responsible for providing
electrical and electronic engineering support and expertise in the definition, design, development and test of medical device products with a particular emphasis on catheter-based ablative therapies such as Renal Denervation (RDN).

This is a leading role in design and troubleshooting of mixed hardware/software systems associated with SUD devices, ensuring compliance with regulatory and safety standards, and contributes to innovation and intellectual property development, enabling safe, effective, and differentiated therapy delivery systems.

Key Resposponsibilities:

• Designs, develops, debugs, modifies, tests electrical circuits and systems for therapeutic ablation catheters and consoles, using current tools, analysis techniques, and technologies.
• Leads troubleshooting and root cause analysis of electronic test failures, driving solutions to component/system level.
• Develops, tests, and characterizes new catheter prototypes and console interfaces from concept through launch in cross-functional teams.
• Analyzes, evaluates, and verifies requirements, circuits, and systems using engineering practices; ensures integration of hardware, firmware, and physiological signal acquisition.
• Investigates, researches, and selects electronic circuits, components, tools, equipment, and practices for advanced ablative therapy devices.
• Documents electrical development through protocols, technical reports, memos, change requests, and design history files, per BSC quality system standards.
• Ensures compliance with medical device safety and EMC standards (e.g., IEC60601 series).
• Mentor junior engineers and technicians; provides technical leadership, feedback, and training to build high-performance teams.
• Translates high-level clinical requirements into robust engineering solutions and identifies opportunities for product innovation and intellectual property.
• Communicates technical updates at weekly team meetings, risks, and milestones to project leaders and senior stakeholders
• In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.
• Assures that appropriate resources (personnel, tools, etc.) are maintained to assure Quality System compliance and adherence to the BSC Quality Policy.

• Establishes and promotes a work environment that supports the Quality Policy and Quality System.

Required:

• Level 8 Honours Bachelor Degree in Electrical Engineering.
• 5+ years of experience in medical devices or other highly regulated industries, preferably with catheter-based or implantable systems.
• Hands-on expertise in circuit/system design, system troubleshooting, and root cause analysis.
• Proven experience with regulatory/safety standards (IEC60601 series, EMC).
• Strong communication, documentation, and project management skills.

Preferred:

• Experience with ablative modalities (RF, ultrasound, IVL, PFA).
• Familiarity with firmware debugging, digital logic, FPGA, and system integration.
• Data analysis (LabVIEW, MATLAB, Python) and automated test development.
• Experience in intellectual property development (patent drafting, disclosures).
• Demonstrated ability to mentor and lead cross-functional teams.