דרושים Process Eng - P4 ב-Boston Scientific ב-אירלנד

Advancing possibilities for a brighter tomorrow

Responsible for providing mechanical engineering support in the creation and the development of new medical device products (invasive and non-invasive). Interfaces with Design, Quality and Manufacturing organizations to integrate new products, equipment sets or processes into production.

Responsibilities:

• Researches, develops, designs, and evaluates mechanical and electro-mechanical materials, components, assemblies, processes and/or equipment.
• Conducts feasibility studies to verify capability and functionality.
• Develops new concepts from initial design to market release.
• Maintains detailed documentation throughout all phases of development.
• Working as part of the Process Development group this person will aid design of new equipment for new products & manufacturing.
• Work closely with machine Vendors in order to ensure that the equipment is designed, built & tested according to Boston Scientific specifications and is properly handed over to manufacturing.
• Applies technical knowledge to innovate, design, and develop processes, procedures, tooling and/or automation.
• Executes the functional deliverables associated with the PDP/TDP and Quality Systems.
• Plans, organizes, and conducts all aspects of technical reviews.
• Ensures proper documentation is completed to meet quality systems requirements. (e.g., BOM’s,FMEA’s, etc.).
• Reviews or coordinates vendor activities to support development.
• Demonstrates knowledge and application of Lean methodologies, and process improvement tools in identification and elimination of "waste" process steps and development of efficient, cost effective equipment and processes.
• Demonstrates knowledge and application of Process and equipment validation techniques (IQ, OQ, PQ), FMEA, and associated regulatory requirements and applies this knowledge in the efficient & timely validation of equipment and processes.
• Co-ordinates execution and documentation of validation builds, co-ordinates testing of validation units and the compilation, analysis and reporting of the validation results.
• Demonstrates a primary commitment to patient safety and product quality.
• Understands and complies with all the regulations governing the quality systems.

Qualifications/Experience:

• Hons bachelors degree engineering degree qualification
• 3+ yrs engineering experience in a GMP environment

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Our Graduate Programme is designed to accelerate your professional development and provide you with extensive experience within Boston Scientific Clonmel. Throughout the 23-month programme, you will be provided with dedicated mentors and will have professional development 1:1 meetings to provide you with a solid foundation for a successful career. Our Graduate Programme is created around hiring the most innovative and best individuals, while Boston Scientific Clonmel provides the means for you to continuously learn and enhance your skill set to drive your career growth.

Responsibilities

• Initiates and completes technical activities leading to new or improved products or process, for current programs, next generation programs and to meet strategic goals and objectives of the company. Prepares reports, publishes, and makes presentations to communicate findings.
• Analyses and solves problems from basic engineering principles, theories and concepts through to a wide range of complex and advanced problems which require novel and new innovative approaches or a major breakthrough in technology.
• Understands engineering principles theories, concepts, practices and techniques. Develops knowledge in a field to become a recognized leader or authority in an area of specialization and applies this knowledge in leadership roles in the company.
• Incorporates business policies and procedures into task completion. Understands the business needs of the company, and has knowledge of the customer needs of our business. Understands the business cycle and foresight of emerging technologies trends.
• Cultivates internal and external network of resources to complete tasks. Serves has a resource in the selection orientation and training of new engineers and employees. May lead a project team, determining goals and objectives for the projects. Mentors employees by sharing technical expertise and providing feedback and guidance.
• Interacts cross functionally and with internal and external customers. Serves as a consultant for engineering or scientific interpretations and advice on significant matters. Acts as a spokesperson to customers on business unit current and future capabilities.

Requirements/ Experience for Graduate Programme

• NFQ Level 8 Honours Bachelor’s degree in a STEM discipline (You must be graduating prior to September 2026orhave graduated in last 2 years
• Must have graduated within the last two years or be in final year at University
• Relevant work experience/ co-op programme completed.
• Strong system skills and aptitude.
• Good communication skills, teamwork abilities and initiative.
• Proven ability to work well as part of a team & on own with minimum supervision.
• Enthusiastic self-starter.
• Strong interpersonal skills.
• Eligible to work in Ireland.

** 23 Month Contract ** Closing Date 27th November

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:

Responsibilities that include data analysis and identification of process improvement. The role will span all operations on site and will give the successful candidate a very good understanding of all aspects of the operation Projects will incorporate lean manufacturing, theory of constraints, quick response manufacturing, Just-In-Time, Methods-Time Measurement, or a variety of other systems improvement philosophies.

Responsibilities:

• Preventative Maintenance & Calibrations.
• Continuous improvement of all types of mechanical and electrical systems, to achieve maximum availability and equipment reliability, in a regulated Medical Device facility.
• Update and maintain all maintenance records in an organised and efficient manner.
• Provision of technical support and troubleshooting on automated controls, electrical equipment and mechanical systems.
• Participate fully in training and development in cross-skilling and other job-related competencies.
• Work in compliance with the site Safe Systems of Work including permitting, LOTO, isolations and safety documentation review.
• Work Collaboratively with Operations, Quality, EHS and other departments.
• Any other reasonable duties which may be required by management from time to time

Requirements:

• Completion of Mechanical/Electrical/Multiskilled Apprenticeship or NFQ Level 6 qualification.
• Experience within Medical Devices or a similar industry is an advantage.
• Knowledge of electrical, mechanical, hydraulic & pneumatic drawings would be an advantage.
• Experience of working on & maintaining Electrical and Mechanical equipment within a regulated industry.
• Experience with SAP based Computerised Maintenance Management System and electronic Maintenance Request Systems.
• Excellent interpersonal and communication skills.
• Strong planning and organizational ability.

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HR Intern

As member of the HR Operations team, you support the further development and execution of our transactional HR Service delivery within Poland. While taking the first steps in your HR career, you also have a chance to experience focusing on continuously improving our HR processes and practices. You will also be involved in a wide range of HR areas across the employee life cycle such as benefits administration, employee systems and reporting, learning and development, payroll, and HR compliance. As part of your internship, you will participate in local and regional HR projects to leverage best-in-class HR services and drive effectiveness and efficiencies whilst increasing customer satisfaction and experiences.

What you will learn:

• Provide HR support and advice to the Managers and Co-workers in developing and generating metrics reporting/tools, HR Processes as applicable
• Resolving or assisting in resolving a variety of escalated HR Operations issues
• Managing data, procedures and/or processes related to HR
• Process new hire and current employee’s administration including e.g. onboarding, preparing employment agreement, entering or updating personal information records, salary information, medical certificates
• Assisting in supervision of personnel and payroll documentation and
• Cooperating with the payroll provider
• Benefits management
• Managing data, procedures and/or processes related to one or more of the following HR systems: Payroll, Employee Data, Compensation, Benefits, Invoicing, Learning and/or Recruitment
• Health and safety requirements maintenance – organizing training for employees
• Time and attendance system management, assistance in current issues, short onboarding trainings regarding time registration and leaves from work
• Provide data and information to others on HR area processes and procedures
• Gather and prepare data in preparation for HR initiatives and programs to include the creation of files/documents in Excel, Word and PowerPoint

What are we looking for in you?

• Bachelor’s degree or studying toward a degree (preferably in Human Resources or related)
• Previous transactional HR Service delivery experience would be an advantage, but is not necessary
• Continuous improvement mindset
• Demonstrated multitasking capabilities and strong attention to detail
• Basic knowledge of Polish Labor law
• Ability to communicate confidently and clearly with various audiences both verbally and in writing
• Polish Native and English fluent (C1) - written and spoken

We offer:

• Intern contract for up to 12 months
• Hybrid working mode (3 days in the office)

• Working in an international environment

• Friendly and supportive work atmosphere

• Opportunity to grow and develop in a team of professionals

• Inspirational colleagues & culture

• A team-oriented company culture

• International opportunities

• Modern office in the center of Warsaw

Job Purpose:

As an, you will have the opportunity to work on a range of projects including leading a product or technology development project, moderate-sized Site Transfer / Acquisition projects, and a site representative for broader Global projects as required.

Key Responsibilities:

• Lead medium/large sized cross-functional development teams.
• Provide input to functional managers on the team and team member performance. Influences & satisfies key project stakeholders through each phase of the project.
• Manage the technical challenges of technology application and new product development; proactively identifies, communicates and manages technical risk engaging the key subject matter experts in this process.
• Develop and implement the project plan proactively identifying risks and embedding appropriate mitigations into plans
• Build team ownership and commitment to the project plan outlining clear decision points Presenting options & recommendations to decision-makers supporting data/rationale.
• Develop and control the project budget throughout the project lifecycle.
• Follow the appropriate applicable project roadmap (e.g. PLCP process for NPI, Product Transfer roadmap for Site Transfers etc.) and represent Operations on the overall Core Team; lead the Operations team to complete all activities to current policies and practices & represents same at all phase reviews.
• Responsible for team and cross-functional communications ensuring appropriate communication is maintained throughout the project with key stakeholders and specific issues/decision points are communicated in a timely manner.
• Ensure the communication is tailored for the audience from Project Team reviews right through to Senior Leadership reviews. Lead phase and business reviews, project meeting minutes, issues log, metrics, and other key communications.

Education & Experience:

• Level 8 Honors Bachelors degree (240 credits) in a Technical discipline (e.g. Engineering, Science, Software, Manufacturing); a Qualification in Project Management and/or a Level 9 (Masters) would be an advantage.
• 5+ years of project management in an Operations or New Product Development environment
• Strong experience in project managing larger-scale / complex projects involving multiple functions (e.g. Divisional R&D, Program Management, Regulatory Affairs, Design Assurance, Process Development, Sustaining Engineering, Global Supply Chain) and/or Multiple Sites (e.g. Global or StAR projects, Strategic Transfers)
• Proven leadership skills in change management and project management.
• Demonstrates excellent verbal and written communications to project team and all stakeholders at multiple levels.
• Must have proven skills in people management, collaboration, influencing and team building.
• Must be proficient with MS Project or similar Project planning tool.
• A formal Project Management qualification or certification is an advantage.
• Strong communication skills across all levels in organization – tailors the message to the audience

Key Responsibilities:

• Co-ordinate and consolidate the month end results for the Site. Provide variance analysis to forecast and annual Plan and help co-ordinate the preparation of the executive summaries that are provided to Leadership team on Site and executive team in US.
• Coordination with global business services, divisional finance teams & local finance team to ensure efficient and effective month end close.
• Co-ordinate and Consolidate the Forecast Quarterly and Annual Operating Plan submission for the Site, and also communicate variance analysis to the Leadership team on Site and help co-ordinate the preparation of the executive summaries that are provided to Leadership team on Site and executive team in US.
• Prepare and consolidate the monthly balanced scorecard summaries (Key Site Metrics) for the Site for the month with key executive level summary. Work closely with the finance team and Leadership team to provide insightful commentaries.
• Business Partnering – Provide financial support to your specific business area through comprehensive review of their financial performance, lead forecast & budgets for their area & provide financial appraisal support with emphasis on HC planning and Overhead Spend analysis
• Maintain effective control systems for areas under your responsibility ensuring full compliance with Corporate Policy, SOX & GAAP.
• Support projects depending on Finance & Business priorities.
• Support the FP&A Senior manager on ad-hoc projects that help drive process improvements.

Education & Experience:

• Level 8 Honors Bachelors Degree in Finance, Business or relevant discipline
• Qualified Accountant ACA / ACCA / CIMA / CPA with 5+ years post qualified experience.
• Experience in a fast paced manufacturing environment would be a distinct advantage.
• SAP experience is an advantage
• Expert level financial system & excel skills are essential.
• Strong analytical & interpersonal skills.
• Aptitude for identifying & implementing process improvements

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