Location: Dublin
Job Purpose
The Senior Process Development Engineer will spearhead the characterisation and validation of critical process steps in the FIRE1 Sensor device manufacturing process, focusing on laser welding and soldering techniques. This role is not only technical but also requires cross-functional collaboration and project management to ensure successful implementation and alignment across various departments. The Senior/Principal Process Development Engineer will play a key role in driving yield improvements and ensuring that products meet industry standards.
Responsibilities
Process Characterization and Validation:
- Lead Process development within FIRE1 across equipment design, process parameters and component control.
- Develop and execute process characterization tools for medical device processes, ideally experienced in yag laser welding and soldering, to develop clear understanding of inputs on outputs.
- Establish and implement validation plans that comply with regulatory standards, ensuring that processes operate effectively within defined specifications.
Continuous Improvement:
- Identify opportunities for process improvement through data analysis, experimentation, and best practices to enhance yield and efficiency.
- Initiate and drive corrective actions and process enhancements based on findings from characterization and validation efforts.
Cross-Functional Collaboration:
- Drive alignment among cross-functional teams, including Quality Assurance and R&D, to ensure all stakeholders are informed, engaged, and supportive throughout the process enhancement journey.
- Foster strong relationships and maintain consistent communication with key teams to facilitate collaboration and shared goals.
Technical Leadership and Support:
- Serve as a technical expert in laser welding and soldering, providing mentorship and guidance to junior engineers and manufacturing staff.
- Collaborate with the Quality and R&D teams to address challenges and streamline processes, ensuring product integrity and compliance.
Documentation and Compliance:
- Maintain accurate documentation of processes, validations, and compliance efforts to meet regulatory requirements.
Outcomes:
- Achieve significant improvements in yield through effective characterization and optimization of laser welding and soldering processes.
- Ensure successful project execution that meets critical deadlines in alignment with the FIRE1’s strategic objectives.
- Build a supportive and collaborative environment that fosters innovation and excellence across engineering, quality, and R&D teams.
This role requires a dynamic individual with strong technical acumen, exceptional interpersonal skills, and a proactive approach to project management, enabling the navigation of complexities and driving success.
Experience & Education
Essential
- Bachelor’s of Engineering or equivalent
Desirable
- A minimum of 10-15 years’ experience in a similar role
- Deep experience with Design of Experiments, statistical methods
Skills
Technical Skills:
- Process Engineering Expertise: In-depth knowledge of manufacturing processes, ideally in laser welding and/or soldering.
- Statistical Analysis: Proficiency in statistical methods and tools (e.g., Design of Experiments, Six Sigma) to analyse and optimize processes.
- Equipment Design: Knowledge of equipment/fixture design desirable
- Material Science Understanding: Knowledge of materials used in medical devices and how they interact with welding and soldering processes.
Interpersonal Skills:
- Cross-Functional Collaboration: Ability to work effectively with diverse teams, including Quality Assurance, R&D, and Operations, fostering alignment and support.
- Communication Skills: Strong written and verbal communication skills to present technical concepts clearly to both technical and non-technical audiences.
- Leadership and Mentorship: Capability to lead projects, mentor junior staff, and influence stakeholders while maintaining positive relationships.
- Problem-Solving Abilities: Strong analytical and critical thinking skills to identify obstacles and develop effective solutions.
Organizational Skills:
- Time Management: Ability to prioritize tasks and manage multiple projects simultaneously, meeting deadlines and company objectives.
- Attention to Detail: High attention to detail for thorough documentation, process validation, and compliance efforts.
- Adaptability: Flexibility to adapt to changing requirements and priorities in a fast-paced manufacturing environment.
Additional Skills:
Manufacturing flow systems: Knowledge of manufacturing methodologies and lean manufacturing principles desirable e.g. cell systems, single piece flow, etc.
Technical Writing: Proficiency in creating detailed technical documentation, validation protocols, and reports.
Data Analysis Tools: Familiarity with software tools for data analysis and engineering applications (e.g., MATLAB, Minitab).
Reporting
Reports to Director of Manufacturing and Supply Chain
