Electrical Eng - P2 jobs at Boston Scientific in Ireland

Job Purpose:

As an experienced Quality Engineer, you will demonstrate commitment to the Quality Policy (patient safety and product quality) through daily execution of sound quality practices and the maintenance of an effective quality system. Understands and complies with all the regulations governing the quality systems. Committed to patient safety and product quality.

Key Responsibilities:

• Takes a preventive approach to Quality Assurance, proactively identifying potential issues.
• Uses strong organisational skills and effective time management to ensure work is completed in a timely manner.
• Effectively prioritises a diverse workload to ensure timely completion of critical tasks.
• Plans and executes both daily tasks and long-term projects to ensure timelines are met.
• Takes a pragmatic and logical approach to challenges faced.
• Explains technical topics clearly to diverse stakeholders through effective communication.
• Promotes a culture of continuous improvement through reflection and factoring in previous learnings.
• Makes informed decisions related to product quality, including dispositioning non-conforming product.
• Evaluates complex quality issues and selects the most appropriate problem-solving tools/ techniques.
• Completes timely scoping and containment of product-related issues when required.
• Documents non-conformances using a high standard of technical writing and detailed understanding of Containment, Disposition, Risk Assessment and Investigation.
• Identifies and drives Corrective Actions when required, to prevent/ eliminate/ facilitate/ mitigate the re-occurrence of non-conformances.
• Reviews Complaints’ signals and completes investigations for individual events/ unfavourable trends.
• Familiar with BSC Quality Systems and ISO/MDD/MDR standards.
• Involved in internal and external audits, including audit facing and presenting processes/ documents to auditors as a subject matter expert.
• Knowledgeable on Risk Management, Design Outputs and product/ process Risk Documentation.
• Uses appropriate statistical tools for sampling, capability, trend analysis, and control charts. Effectively interprets and presents conclusions drawn.
• Participates directly in a new product/technology transfer, ensuring compliance to all internal and regulatory requirements.
• Uses knowledge of Six Sigma, Statistical Analysis and Lean Principles to solve problems effectively.
• Involved in change control for work instructions, protocols/ reports and technical documents, either as a change owner or quality approver.
• Evaluates new equipment/processes/chemicals for safety and environmental impact/effect, in conjunction with EH&S.
• Completes validations for processes/ test methods in line with requirements and best practices.
• Maintains relationships and gives technical guidance to Quality Technicians.
• Deals with suppliers, other engineering disciplines within and outside of the site as required.

Education & Experience:

• A Level 8 Degree (240 Credits) or equivalent in a STEM discipline.
• A minimum of 5+ years relevant experience, ideally within the Medical Device industry or another highly regulated environment.

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Key Responsibilities:

• The ability to perform failure analysis on electronic test equipment.
• Using knowledge of standard system software applications, able to work with in-house and external software developers to define and drive improvements and changes to test applications and systems to improve manufacturing test yields.
• Work with cross functional groups to improve product quality, lean efficiencies and test system efficiency’s and reduction in production fallout.
• Performs tests, writes reports and executes validations to medical device standard for Test and Manufacturing processes.

• Excellent data analysis and technical problem-solving skills and project time management
• Utilizing good documentation skills, complete regulatory submissions using change notice process and procedures.

• Work daily with quality, manufacturing, R&D and Design to efficiently implement product transfer.
• Work with PM to develop manufacturing project timelines.

Education & Experience:

• Hons BSc degree in electrical engineering or related discipline.
• 5+ year’s relevant experience in a related industry.
• Experience in an electrical engineering-related environment essential.
• Strong working knowledge of process validations 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 and new product transfers would be an advantage.

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Job Purpose:

role. Sterilization operates in a 24/7 shift pattern (12-hour shift).

Note Job shifts:

Day1 Mon to Wed (7AM to 7PM), alternating Sunday

Day2 Thurs to Sat (7AM to 7PM), alternating Sunday

Nights1 Sun to Tues (7pm to 7AM), alternating Saturday

Nights2 Wed to Fri (7PM to 7AM), alternating Saturday

Responsibilities:

• Work with Line Facilitators to manage the process, the process loads and Production Area.
• Work with Manufacturing Engineers in developing, trouble shooting, standardising and improving existing production methods and procedures.
• Work with Engineering team to commission and validate new sterilization equipment.
• Support and assist on equipment and cycle qualifications and validations.
• Proactive on PSPI and PDCA in the area.
• Work on Electronic/ Mechanical troubleshooting and electronic hardware interfacing.
• Investigate and implement new production methods.
• Interface with a variety of BSI personnel and with outside vendors when necessary while performing the above.
• Take responsibility for preventative maintenance procedures with an assigned process or area.
• Assists in implementing technical improvements under the teams C.I. program.
• Communicates any concerns about work process regarding environmental impact, health or safety issues to their manager.
• Owns the key performance metrics for the ME function.

Qualifications and Experience

• HETAC NFQ Level 6 Honors Degree in STEM
• Sterilization experiences an advantage.
• Strong focus on safety and safety procedure adherence.
• Strong electromechanical experience required.
• Plant equipment experience an advantage.
• Electrical level 2 or 2+ years relevant years experience required
• Comfortable working with full PPE (respiratory gear etc) – requirement to be clean shaven
• Experience with Gas cylinders an advantage
• Drives continuous improvement efforts
• Good technical capabilities, communication skills, teamwork abilities and initiative.
• Proven ability to work well both as part of a team but also able to work on own with minimum supervision

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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:

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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