Our Mission:
At Boston Scientific Galway, we are dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world.
We work collaboratively to solve healthcare’s toughest problems by developing solutions that matter most to those suffering from debilitating and life-threatening conditions and to the healthcare professionals who provide their care.
We are seeking a Process Engineer III on a permanent basis to join us on our mission.
Job Purpose
Works cross-functionally to lead the development of robust, capable, cost effective & safe Extrusion, Balloons & Moulding processes, equipment, materials and products. Ensures efficient and effective transfer of new products & processes into commercial production.
Key Responsibilities:
* Provides Technical Leadership to Engineers and technicians within own team and to wider Stakeholders to provide direction on optimum solution(s) to the Process Development of new Moulded, Extruded and Balloons Components.
* Provide scientific understanding and technical engineering skills to meet business goals and objectives. Ability to coach, lead and enhance the productivity of technical reports within the business. Provide a structured framework for training of technical reports. Build collaborative relationships through strong teamwork across the organization.
* Initiates cross-functional partnerships to identify and resolve process related issues.
* Liaises with other relevant functions with regard to ongoing development of current processes and systems and future development needs.
* Develops detailed Project Plans to support major new product/process introductions.
* Provides Technical Leadership in the selection, design, optimisation, validation and troubleshooting, of key processes & product technologies.
* Leads the development and execution of experimentation and testing to enable characterization, optimization and troubleshooting of key processes and equipment. Summarises, analyses and draws conclusions from test results leading to effective technical resolution.
* Facilitates the use of Six Sigma & Problem Solving tools leading a team of engineers and technicians in the characterization, optimization and trouble-shooting of process equipment and technology performance.
* Liaises with Equipment Engineering or external equipment/tooling or material vendors in the selection, design & development of new (or upgrades to existing) equipment, tooling and materials.
* Prioritizes and drives execution of multiple complex projects. Sponsors and supports team initiatives where required.
* Co-ordinates the introduction of new processes, equipment and materials including installation, calibration, EHS assessment debug, and all associated process and quality system documentation requirements including technical and process work instructions.
* Demonstrates strong 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 strong knowledge and application of Process and equipment validation techniques, PFMEA’s/PRA's and associated regulatory requirements and applies this knowledge in the efficient & timely validation of equipment and processes.
* Leads the writing and release of process validation documentation including PFMEA/PRAs, Validation Plans, protocols and reports.
* Leads execution and documentation of validation builds, co-ordinates testing of validation units and the compilation, analysis and reporting of the validation results.
* Supervision of one or more Engineers or Technicians, managing their technical development and facilitating their daily and project tasks.
* Demonstrates a primary commitment to patient safety and product quality.
* Understands and complies with all the regulations governing the quality systems.
* May Guide, coach, direct a group or team of employees in the achievement of goals.
* Foster a diverse workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives.
* Monitor and ensure compliance with company policies and procedures.
* Collaborate and influences the opinions and decision making of others internally or with external partners/vendor/customers to achieve objectives.
* Leads briefings and technical meetings for internal and external stakeholders concerning specific projects.
* Ensures all direct reports are aware of their commitment to patient safety and product quality, are current with their training requirements and that they understand and comply with all other regulations governing their work.
Education & Experience
* Level 8 Bachelors Degree in Polymer Engineering/Science or equivalent (240 credits)
* 5+ years experience as an Engineer supporting New Product Development of extruded components, Injection moulded components, and next generation Balloon Moulding processes for the medical device industry required.
* Experience in Top Assembly manufacture also an advantage.
* Good technical capabilities and ideally validation experience.
* Strong 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.
At Boston Scientific, we recognise that nurturing a diverse and inclusive workplace helps us be more innovative. It is essential in advancing science for life and improving patient health. We stand for inclusion, equality, and opportunity for all. By embracing the richness of our unique backgrounds and perspectives, we create a better, more rewarding place for our employees to work and reflect the patients, customers, and communities we serve. Boston Scientific is proud to be an equal opportunity and affirmative action employer. Boston Scientific is committed to providing reasonable accommodations for applicants and employees with a disability. Should you require a reasonable accommodation during the recruitment process, please let us know.