דרושים Senior Equipment Engineer ב-Boston Scientific ב-Ireland, Cork

Job Purpose

In Operations, provide daily support of products, processes, materials, and equipment in order to achieve production goals (i.e., quality, delivery, cost, productivity, and safety). In New Product Development and Sustaining Engineering, support the development and advancement of product design deliverables for next generation and already commercialized products.

Key Responsibilities

• Build Quality into all aspects of work by maintaining compliance to all quality requirements.

• Assists to define and implement all Quality standards and specifications and helps to ensure that Corporate and Regulatory requirements are met

• Identifies and resolves moderately complex exceptions to work assignments

• May participate directly in a new product/technology transfer to gain the necessary experience/exposure which such a challenge presents.

• Uses knowledge of Six Sigma, Statistical Analysis and Lean principles to investigate and solve problems and improve quality.

• Will be broadly conversant with validation techniques and associated Regulatory requirements including analysis of customer feedback and complaints.

• Understands and proactively follow through on the Environmental Management.

• Actively interacts with cross-functional team members, always practicing good teamwork, in support of day-to-day operating requirements.

• Demonstrates best practices in line with the department and site objectives.

Education & Experience

• NFQ Level 8 Honours Bachelor’s degree in a STEM discipline is required. (You must be graduating prior to September 2026 or have graduated in last 2 years)

• An understanding of systems and a willingness to learn and develop technical skills.

• Good communication skills, teamwork abilities and initiative.

• Proven ability to work well as part of a team & on own with minimum supervision.

• Eager to learn and active participate.

• Strong interpersonal skills.

• Eligible to work in Ireland.

• Competitive Benefits –we offer market leading benefits including performance-related bonus, pension contribution, onsite gym, onsite parking, subsidised canteen, organised social groups and healthcare.

• – opportunity to transform the lives of patients worldwide.

• - our work is guided by core values that define our culture and empower our employees.

• Career Development– our highly engaged leaders will empower you to grow and will invest in your potential. You can also broaden your skills through personal development courses.

• – we encourage you to fulfil your true creative potential by speaking up with your ideas and solutions to problems that matter.

• – we have created a culture that acknowledges, respects and supports your life and work choices.

• Corporate Social Responsibility– we are dedicated to progressing business practices in areas important to our communities. Our onsite charity events have raised over €1.5 million for worthy causes in the past ten years.

To search and apply for open positions, visit:

Job Purpose

In Operations, provide daily support of products, processes, materials, and equipment to achieve production goals (i.e., quality, delivery, cost, productivity, and safety).

Key Responsibilities

• Uses problem-solving methodologies to support issue investigations and make improvements.

• Actively interacts with cross-functional team members through face-to-face meetings, virtual video calls, emails or group sessions.

• Practices good teamwork by actively listening, sharing ideas and working together as one team, in support of day-to-day operating requirements.

• Assists in the development and analysis of process, product, material or equipment specifications and performance requirements

• Evaluates new equipment/processes/chemicals for environmental impact to eliminate or lessen such impacts in conjunction with Environmental Health and Safety (EHS)As part of personal development, may assume engineering responsibility for manufacturing equipment or processes within the cleanroom environment.

• Interfaces with vendors, possibly physicians and other technical consultants as part of the role.

• Builds Quality into all aspects of work by maintaining compliance to all quality requirements in Standard Operating Procedures.

Education & Experience

• NFQ Level 8 Honours Bachelor’s degree in a STEM discipline is required. (You must be graduating prior to September 2026 or have graduated in last 2 years)

• An understanding of systems and a willingness to learn and develop technical skills.

• Good communication skills, teamwork abilities and initiative.

• Proven ability to work well as part of a team & on own with minimum supervision.

• Eager to learn and active participate.

• Strong interpersonal skills.

• Eligible to work in Ireland.

• Competitive Benefits –we offer market leading benefits including performance-related bonus, pension contribution, onsite gym, onsite parking, subsidised canteen, organised social groups and healthcare.

• – opportunity to transform the lives of patients worldwide.

• - our work is guided by core values that define our culture and empower our employees.

• Career Development– our highly engaged leaders will empower you to grow and will invest in your potential. You can also broaden your skills through personal development courses.

• – we encourage you to fulfil your true creative potential by speaking up with your ideas and solutions to problems that matter.

• – we have created a culture that acknowledges, respects and supports your life and work choices.

• Corporate Social Responsibility– we are dedicated to progressing business practices in areas important to our communities. Our onsite charity events have raised over €1.5 million for worthy causes in the past ten years.

To search and apply for open positions, visit:

Advancing possibilities for a brighter tomorrow

Purpose Statement:

Responsible for planning and execution of day-to-day activities within the supplier engineering department. Directs work of individual contributors to perform to defined plans or work instructions. Develops plans of moderate scope and complexity. Develops and accomplishes weekly and monthly goals and objectives.

Key Roles & Responsibilities:

• Supervises the execution of plans to support supply chain objectives; supplier performance, supplied material risk mitigation and execution of materials VIP.
• Setting priorities, scheduling and assigning tasks. Manages changing priorities by flexing assignments as needed to keep the line running.
• Develop each group member so they are proficient at executing to plan. Assist each group member in career development.
• Provide technical leadership for the supplier engineering team. Act as a functional SME in own area of expertise; leverage technical support from others in areas of low familiarity.
• Understand FDA, ISO and corporate requirements pertaining to qualification of supplied material.
• Support qualification of second sources for existing supplied material.
• Develops plan to execute materials VIPs; monitors progress and escalates where necessary.
• Support resolution of line down issues at vendors to maintain business continuity
• Providing resources to and interfacing with product development teams.
• Execute projects within expense and capital budget.

Quality Systems Requirements

For those individuals that supervise others, the following statements are applicable:

• 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

Functional Knowledge

• Requires in-depth understanding and application of concepts, procedures and practices within own job function; has broad experience in applying this knowledge in a variety of situations

Business Expertise

• Applies business practices and methods in own job function; ensures own team integration with related areas to deliver programs, services and results

Leadership

• Manages support and/or early career professionals within own job function, coordinates resources and sets short-term priorities to meet operational objectives
• Adopts and implements functional, technical, service and/or process improvements that impact the flow of the own team(s)

Problem Solving

• Identifies, anticipates, troubleshoots, and resolves day-to-day functional, technical, operational and service problems; may establish new techniques to ensure the team is able to meet its objectives
• Works under general direction and is guided by company policies, guidelines and procedures

Impact

• Makes decisions that improve the quality, efficiency and effectiveness of own team and related teams
• Guides by using policies and procedures and cascaded goals and objectives
• Provides input on resource planning, guidelines, processes and procedures

Interactions (and Communications)

• Explains information to team members, internal clients and/or peers, conveys performance expectations and handles complex sensitive issues
• Works to establish collaborative relationships with internal and external contacts to achieve team objectives
• Handles challenging issues with employees and/or customers (internal or external) using sensitivity; effectively diffuses contentious or uncomfortable situations

:

• Minimum of a Honours bachelor’s degree (Level 8) in engineering or equivalent fields of study.
• 3-5 years of professional experience, preferably within the medical device industry.
• Strong leadership skills with ability to influence and drive cross-functional performance

• Ability to communicate effectively with individuals on all levels (written and verbally)
• Results-oriented with strong organizational skills and ability to manage competing priorities.
• Strong problem-solving and critical thinking skills, analytical and process-driven

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Job Purpose:

You will provide support for both new and current manufacturing equipment in regard to design, installation, troubleshooting, performance and validation activities.

Key Responsibilities:

• Generate documentation for the detailed specification, design, development and testing of new equipment & automated systems

• Develop detailed knowledge & understanding in all aspects of automation systems including PLC, HMI, vision, robotics, PC software and databases.

• Develop a detailed understanding of Overall Equipment Effectiveness (OEE) and use of same to drive optimum equipment utilisation/operation.

• Identify equipment & automated system upgrades as part of continuous improvement programs, improving equipment/systems in terms of performance, qualify & availability.

• Provide technical support and make informed decisions on hardware and architecture selection

• Analyse, understand & fault-find as necessary on complex automation equipment

• Develop, test and install code changes to existing equipment under change control

• Maintain comprehensive documentation of code to medical device standards

• Actively participate among cross-functional teams to ensure projects are delivered on time and to required quality standards.

Education & Experience:

• Degree in Automation/Electrical/Electronics/Mechatronics/Software or related Engineering discipline with at least 5 years relevant experience

• Experience working with automation systems & automated production equipment essential
• Excellent working knowledge of PLCs: Allen Bradley, Siemens, Beckhoff, GE Fanuc, Mitsubishi, Omron, Toshiba etc.
• Experience of HMI or SCADA programming and configuration

• Hands-on working experience with Allen Bradley and Siemens PLC’s a distinct advantage.
• Hands-on working experience with Robotics & Vision system applications is an advantage
• Excellent analytical and Technical problem-solving skills essential
• Strong organisational skills

• Strong Leadership & Influencing skills
• Works well within a team environment and on own initiative

• Ability to document own work clearly and precisely

• Excellent communication skills

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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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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

Advancing possibilities for a brighter tomorrow

Key Responsibilities

• Drive and implement process improvements to ensure predictable processes across shipping and boxpack processes (e.g. Risk Reduction, Yield improvements, Customer complaint reduction, Error proofing, Cost Reduction initiatives, Process Automation activities).
• Provide effective and responsive QA support to Operations to meet their area’s objectives of quality, cost and output.
• Ensure all process variables and their interactions are adequately defined. Ensure all failure modes in process have been identified and addressed. (e.g. Use of DOE studies, FMEA’s).
• Drive and implement plant wide quality system improvements.
• Ensure Regulatory compliance in area of responsibility to cGMP’s of all medical device regulatory agencies (e.g. FDA and TUV).
• Provide functional expertise to other support functions on quality related issues (e.g. regulatory requirements, statistical techniques, sampling principles).
• Identification and implementation of appropriate statistical techniques to monitor process performance (e.g. SPC, CpK analysis, sampling techniques).
• Approval of change requests for product, process and quality system changes.
• Customer complaints: Analysis of returns, approval of analysis reports and analysis of complaint trends.
• Validation: Define process, product and test method validation requirements, preparation and approval of Master Validation Plans, protocols and reports approval.
• Compilation of required Regulatory documentation (e.g. Technical files, Design Dossiers, Product transfer files, Essential requirements).
• MRB: Review of MRB trends and identification of appropriate corrective actions when required.
• Support the implementation of Lean Manufacturing across the site.
• Transfer and implement product and processes from development or from another manufacturing facility.

Education & Experience

• Minimum of Bachelor of Science Degree in Engineering/Technology.
• 3/4 years’ experience in a manufacturing environment or equivalent with direct experience in a QA environment (preferably GMP regulated).
• Experience in the medical device industry is an advantage.

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