דרושים Process Engineer Iii ב-Boston Scientific ב-אירלנד

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 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.

Job Purpose:

Be part of pioneering development work within major new product development projects, specifically focusing on the Urology market and active implantable systems.

You'll be at the forefront of designing, defining, verifying and implementing system requirements for intricate customer systems, as well as conducting comprehensive studies and analyses of existing systems.

Key Requirements:

• Drives complex or novel assignments requiring the development of new or improved techniques and procedures. Work is expected to result in the development of new or refined technologies, products and materials to broaden BSC’s portfolio, specifically in the area Test Method Development and Validation
• Successfully completes electrical engineering type work in one or more of the following: technology development, product design and development, test of materials or product, preparation of specifications, process study and report preparation
• Leadership: Take charge of leading workstreams ensuring robust performance through the design, development and validation of "Use Case", performance and reliability Test Methods including “Off-The-Shelf” software
• Possesses problem solving and test method equipment troubleshooting techniques, leading to solutions to complex technical problems whilst adhering to regulatory requirements, projects deadlines and products costs
• Assesses the feasibility and soundness of alternative engineering processes, products, or equipment
• Documents system requirements by writing documents, reports, memos, change requests. Methods used are determined by approved procedures and standards
• Authors, collaborates, and presents data to the technical community
• Assists in strategic planning for the team
• Write and submit intellectual property (patents)

Education & Experience:

• Hons bachelor’s degree in engineering, science or relevant discipline
• 3+ years engineering experience, preferably in R&D Team
• Experience in highly regulated environment
• Experience in R&D and New Product Development in medical device industry highly desirable but not essential.

Advancing possibilities for a brighter tomorrow

Purpose Statement:

Provide Quality Engineering support to Boston Scientific Clonmel Neuromodulation Implantable Pulse Generator commercial and development manufacturing lines ensuring delivery of the highest quality product to the customer while supporting continuous improvement projects and quality initiatives. Partner with product development teams to provide quality engineering support and help ensure development of highest quality new products. This position requires interactions with multiple value streams and may also require interactions with multiple divisions across Boston Scientific.

Key Roles & Responsibilities:

• Quality lead on value stream and quality & cost process improvement projects.
• Identifies and controls Manufacturing process defects (scrap, nonconforming material, customer complaints) by participating in efforts/teams focused on identifying the primary root causes and implementing corrective and preventive actions.
• Lead on Preventive Quality initiatives in value stream. Driving & participating in WSVA program to support the Production Area Strategy.
• Collaborate cross functionally with local and divisional team members on assigned projects to ensure quality compliance.
• Identify & lead quality projects to support production unit area strategy.
• Coordinates and conducts technical investigation and documentation of non-conforming events and trends, and develop technical investigation plans using Engineering Essentials. Investigates and analyse customer/internal complaints.
• Ensure Regulatory compliance in projects of responsibility by utilising quality tools and processes (PFMEA, Risk reduction, process change analysis).
• Ensure that corrective and preventive measures meet acceptable reliability standards. Analyse preliminary plans and develop reliable engineering programs to achieve company, customer, and governmental agency reliability objectives.
• Develop and/or review Process Qualifications, Test Method Validations, Gage R&R’s, Process Capability studies, Design of Experiment (DOE), production control plans.
• Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.

Education & Experience:

• Honours Degree/Level 8 qualification in Engineering/Quality/Science with a minimum 2 years’ experience in a Medical Device environment or related industry.
• Demonstrate strong leadership & communication skills and promote quality at source.
• Strong Project Management skills combined with proven consistent execution within committed quality, time, and cost targets.
• Experience/training in problem solving and process improvement methodologies (Engineering Essentials).

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Key Responsibilities:

• Lead electronics designs from concept to production
• Become a Subject Matter Expert (SME) for design of external electrical medical equipment for new product development projects as well as sustaining engineering and value improvement projects
• Analyze and assess technical reports and other information to make recommendations for electronic components and design approaches
• Continuously improve processes and work methodologies by interfacing with peers/cross-functional groups and analyzing activities to improve workflow and work processes
• 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
• Must have good communication and interpersonal skills
• Provide Technical support, as required, to technology and product development teams
• Must be a self-starter, manage own time and prioritize tasks based on business priorities
• Ability to delegate tasks of larger projects across a development team
• Previous experience in the technical mentorship of junior engineers

Education & Experience:

• Hons bachelor’s degree in electronic, computerengineering or equivalent
• +5 years’ experience in the medical device industry or other similarly regulated field

• Experience working with international standards such as IEC 60601 and IEC 61000

• Strong communications and time management abilities
• Strong technical knowledge of electronic design including electronic simulation, schematic capture, and PCB layout
• Experienced in design of drive and control electronics for DC, stepper, and BLDC motors.
• Lab skills and experience with debugging, prototyping, general test equipment setup for electronic designs.
• Experience in designing to solve and mitigate EMC issues
• Deep understanding of requirements adherence principles (product specifications, etc.)
• Prior experience working with external vendors.

Preferred Qualifications

• Master’s degree in a relevant field
• Experience as a technical leader in more than one project
• Familiarity with design for manufacturing (DFM) and design for test (DFT)

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Advancing possibilities for a brighter tomorrow

Key Roles & Responsibilities:

• Identifies and controls Manufacturing process defects (scrap, nonconforming material, customer complaints) by participating in efforts/teams focused on identifying the primary root causes and implementing corrective and preventative actions. May be responsible for querying & bounding data to support implementation of complex & documenting release criteria.
• Develops product quality plans, documents and systems by creating product specifications, quality specifications and quality plans in conjunction with other product development team members. May be responsible for creating risk analyses and FMEAs.
• Develops Process Monitoring Systems by identifying critical process steps applying methods to reduce process variation in order to reduce/eliminate the cause of defects.
• Leads process improvement efforts by identifying methods to capture quality metric data and by performing appropriate analysis methods to enhance sustaining product design and new product development.
• Assists in creation of Quality Tools & Training Materials by understanding the limitations of existing quality tools and training materials, and by helping to identify more effective tools & materials.
• Evaluates the adequacy and compliance of systems, operations, and practices against regulation and company documentation. Could serve as auditor of areas of the BSC quality system, such as development and manufacturing, as assigned.
• Responsible for the final Process Monitor Release for products prior to distribution.

Required Qualifications:

• 2-5 years’ experience in Manufacturing or Quality with a honours degree qualification in Engineering or related technical/Quality discipline.
• Excellent written and verbal communication skills
• Demonstrated ability to work with cross functional organizations in a dynamic manufacturing environment to solve problems
• Strong command of MS Office – Word, Excel, PowerPoint.
• Ability to rapidly learn and use new applications

Preferred Qualifications:

• Previous experience in a Quality, or Manufacturing background.
• Experience in the medical device industry.
• Working knowledge and understanding of FDA, ISO13485, and the medical device industry quality requirements associated with manufacturing and supplier controls.
• Experience in problem solving and process improvement methodologies.
• Process Validation, Risk Management, CAPA experience.

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