דרושים R&d Eng - P5 ב-Boston Scientific ב-אירלנד

About the role

The ideal Principal Design Quality Assurance Engineer will bring their leadership to new product development projects and sustaining projects for our innovative electrophysiology cardiovascular products portfolio. Furthermore, they will develop, establish, and maintain quality-engineering methodologies, systems, and practices which meet BSC, customer, and regulatory requirements.

Your responsibilities include:

• Lead Quality function for product development teams within the BSC Quality System to develop new Medical Electrical Equipment (MEE) and Medical Electrical Systems (MES) as part of a core group of Design Quality Assurance (DQA) Engineers.
• Provide quality and compliance inputs to project teams for project decisions and deliverables (i.e. Design Change Analysis; Design Inputs, Design Outputs; Test Method Development and Validation; Design Reviews; Design Verification and Validation; Usability Testing; SW Validation; Process Validation; and Labeling).
• Provide quality and compliance inputs for post market product sustaining activities, such as design changes, Non-Conformance Reports (NCEP); Corrective and Preventive Actions (CAPA’s); Product Inquiry Report/Field Action Assessment (PIRs); Field Signals Evaluations and Field Actions.
• Lead Risk Management processes for new products with key inputs from cross-functional product development teams (i.e. Risk Management Plan, Risk Management Report, Risk/Benefit Analysis, Hazards Analysis, dFMEA, pFMEA, etc.)
• Engagement with project teams for Systems Engineering and Systems Risk Management as a Subject Matter Expert (SME).
• Lead NPD projects as a DQA SME and work with R&D Product Development Engineers to review Hardware/Software systems architecture(s) and identify possible failure modes/risk control opportunities for these complex systems.
• Responsible for collaborating within a team to identify and implement effective controls to support development or maintenance of products to meet internal and external requirements.
• Builds quality into all aspects of work by maintaining compliance to all quality requirements.
• Support internal and external regulatory audits as required.
• Other duties as necessary or required by the organization.

what we're looking for in you:

Required Qualifications

• B.Sc in Biomedical, Electrical Engineering or equivalent.
• 10 years of medical device engineering experience, with experience inMedical Electrical Equipment/Systems (MEE / MES).
• Applied knowledge in the verification and validation of Capital Equipment, including hardware, software, firmware, and systems of systems interdependencies.
• Experienced in working in a regulated environment for example FDA, ISO standards, EUMDR, IEC 60601, EN ISO 14971, IEC 62304 and EN ISO 13485.
• Strong leadership, relationship building, and team building skills.
• Demonstrated ability to mentor and coach others in analysis and risk based decision-making processes to balance business and compliance needs.
• Strong communication and presentation skills.
• Strong applied knowledge of statistical concepts, tools, and methodologies.
• Travel approximately 5-10%.

Preferred Qualifications

• Experience with Software as a Medical Device (SaMD) and/or systems integration

Maximum Salary: $ 197000

Compensation fornon-exempt (hourly), non-sales rolesmay also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements).

Compensation forexempt, non-sales rolesmay also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements).

For MA positions: It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability.

Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements. As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company’s policies or protocols change with regard to COVID-19 vaccination.

Among other requirements, Boston Scientific maintains specific prohibited substance test requirements for safety-sensitive positions. This role is deemed safety-sensitive and, as such, candidates will be subject to a prohibited substance test as a requirement. The goal of the prohibited substance testing is to increase workplace safety in compliance with the applicable law.

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:

To search and apply for open positions, visit:

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.

To search and apply for open positions, visit:

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.

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.