Fellow Process Eng - P6 jobs at Boston Scientific in Ireland

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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Key Responsibilities;

• Lead the technical transformation for metal-additive technology to become a vertically integrated solution for scaled active implantable component manufacturing.
• Serves as a key resource or expert within their function; sets technical direction for the metal-additive centre-of-excellence within the organization.
• Investigates needs of future product designs and develops process technology plans to support development teams; provides sound business rationale for investment in proposed research or technology.
• Studies and understands relevant published articles and works to either apply them directly to our advanced engineering problems or to develop working relationships with parties for accomplishment of same.
• Provides technical leadership and mentorship to more junior members of the team.
• Provides key technical influence on the departmental strategy and technology roadmaps.
• Evaluates process technologies at other BSC sites and externally to BSC and leverages where applicable; serves as key contact for technical queries from other BSC sites.
• Sets direction for education efforts and mentoring in their area of expertise.
• Serves as a contributor on technical review teams; provides risk assessment and recommendations.
• Fields requests from TDP and PDP teams and makes recommendations relative to proposed concepts or approaches.
• Publishes and presents to the technical community on behalf of Boston Scientific, as applicable.
• Reviews and assesses processes for potential patent opportunities; generates IP as applicable.

What we are looking for;

• Hons Bachelors Degree in Engineering or similiar discipline.
• Minimum 5-7 years experience demonstrated in a Technical leadership environment.

Advancing possibilities for a brighter tomorrow

About the role:

Your responsibilities include:

• Leading Sustaining Engineering projects and activities:
o Collaborating with Operations team to achieve product standard cost targets
o Supporting product line expansions to achieve revenue growth opportunities
o Maintaining product quality, safety and compliance
• Supports Design Transfer activities from New Product R&D to Sustaining Engineering and Production.
• Partners with teams in problem-solving and driving efficient technical decisions.
• Develops product performance specifications and validated test methods.
• Collaborates cross-functionally to identify and resolve technical issues.
• Collaborates with Sustaining R&D Management to continually improve Sustaining, Neuromodulation and BSC.
• Supports design related CAPA projects, Value Improvement Projects (VIP), business continuity projects, as well as corporate strategic projects.
• Trained in all aspects of change management including Process, Design, Supplier Change, and new product introduction.
• Develops and implements supporting documentation in compliance with QSR and GMP and in alignment with the cross-functional team.
• Project planning in support of Sustaining projects and activities.
• Maintains compliance with all regulations governing the quality systems.

• Bachelor’s degree in engineering or other related technical field or equivalent experience.
• 5+ year’s medical industry experience with design controls and process validation.
• Test method development and validation.
• Ability to provide technical leadership as it relates to product, design, and process.
• Excellent organizational, communication, and collaborative skills.

Advancing possibilities for a brighter tomorrow

The role will provide support to the development , Manufacturing and compacity ramp of endoscopy SUDs in BSC Clonmel. Ensure that development and production goals are met with a specific emphasis on the development, modification and troubleshooting of Equipment/Process requirements. This role entails process and equipment ownership in multiple areas – owns and drives process and equipment improvements and drives strategic projects. Role includes opportunities to mentor junior engineers and technicians. Collaborates with other BSC sites both virtually and during multi-site visits. Interfaces with Quality and Research and Development organizations to integrate new endoscopy products or processes into the existing scopes manufacturing area and to address any quality issues.
Responsibilities:
• Support the manufacture and capacity ramp up of endoscopy product in BSC Clonmel.
• Develop an in-dept knowledge of the manufacturing process for the scope’s products including all aspects of production and process controls in-place on these manufacturing lines.
• Develop and perform equipment/software qualifications, Process characterisations, process validations and Test Method Validations in support of capacity ramp.
• 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.
• Process owner for defined area and drives ownership of Engineering activities/methodologies with an emphasis on Equipment/Systems validation lifecycle to approved procedures and standards
• Demonstrates a wide knowledge of endoscopy SUDs processes, technologies and ability to develop expertise quickly.
• Evaluates and leads the implementation of new Equipment/processes through research, analysis, evaluation, selection of software designs, operating systems with identification/verification of requirements using engineering best practices.
• An expert problem solver with understanding of engineering principles theories, concepts, practices and techniques. Coordinates and conducts technical investigation and documentation of non-conforming events and trends and develop technical investigation plans using BSC Engineering Essentials.
• Continuously improves process and work methodologies by interfacing with peers/cross-functional groups and analyzing activities to improve workflow and work processes.
• Be part of a strong team culture around high expectations & high performance.
• Provide clear communication to stakeholders at key technical updates
Qualifications and Experience:
• Hons Bachelors Degree in Engineering/Science essential
• 3+ years of experience in a manufacturing environment required.
• FDA experience highly desirable but not essential.
• Six Sigma/problem solving methodologies
• Experience in Validation lifecycle
The successful candidate must be a self-starter with the ability to work on own initiative, while possessing strong team player characteristics.