Senior Process Development Engineer
Job ID: JOB-12523
Senior Process Development Engineer
About the role: Be a part of one of the fastest growing divisions supporting process development for exciting new products, and business development activities. Use your technical and collaboration skills alongside your passion for innovation and continuous improvement to drive growth through efficient and effective commercialization of new products and targeted improvements. The Senior Process Development Engineer position is responsible for the design and development of new and improved manufacturing processes and ensuring efficient and effective transfer of product into production. Serves as a core team member and may also lead/manage derivative or design change projects of disposable medical devices site lead on a cross functional team of disposable medical devices. Seeks to improve existing processes within a New Product Development project that then may be shared across other lines. Manage and leads complex projects independently with minimal supervision.
Your responsibilities will include:
- Work as part of a development team to create and implement new manufacturing processes for new disposable medical devices.
- Perform Design of Experiments for process definition and optimize equipment parameters for new and/or existing processes.
- Create documentation to support new and improved manufacturing processes.
- May serve as a Process Development Technical Lead for new product development projects providing project management and technical guidance to the team.
- Communicate project status to all levels of leadership, including performance, cost, and schedule updates.
- Collaborate with divisional and site level partners to ensure successful new product launches.
- Use of Six Sigma, Lean, and Mistake proof methodologies in the development of manufacturing processes to implement processes that are ‘born lean and capable’. Write and perform process validations (IQ, OQ, PQ) and validate methods for inspection for verification and process controls.
- Assesses process capabilities, prioritizes process improvement opportunities, and innovates and implements process improvements on platform or derivative projects.
- Applies technical knowledge to innovate, design, and develop processes, procedures, tooling and/or automation.
- Technology assessment and selection for new manufacturing processes
- Ensures proper documentation is completed to meet quality systems requirements. (e.g., BOMs, Routers, FMEAs, DMR and DHF documents, etc.)
- Oversees development builds associated with the project using special work requests.
- Provides Design for Manufacturability (DFM) and lean manufacturing inputs to the engineering print package.
- Contributes ideas to or generates Intellectual Property submissions.
- Establish and support a work environment of continuous improvement that supports BSC’s Quality Policy, Quality System and appropriate regulations for the area they support.
- May supervise or coach technicians, engineers or other support employees. Trains and/or provides work direction to direct reports, and may train manufacturing personnel when required as part of a validation. Ensure employees are trained to do their work and their training is documented.
- Must comply with requirements of ISO 14001, Design Control, and BSC Environmental, Health and Safety standards and follow procedures and instructions related to these standards.
What we’re looking for in you:
- Bachelor’s degree in Electrical, Mechanical, Biomedical or other related engineering degree
- Minimum of 5 years medical device experience in process/manufacturing engineering role, three of which have been in managing projects.
- Must have excellent mechanical aptitude, communication and interpersonal skills.
- Must be experienced in MS Word, Excel and Project.
- The ideal candidate will have previous experience in the areas of Design for Manufacturing (DFM),
- Lean Manufacturing, and Process Control Concepts, Design of Experiments (DoE), Software Validation, Technology/Process Transfer experience, and product/process Failure Mode and Effects Analysis (FMEA).
- Use of Problem Solving and Process Improvement Methodologies (e.g. 6 Sigma) and managing improvements through CAPA.
- Understanding of DFM, medical device design control / quality systems and the product development process.
- Experience with CAD Software (Solid Works & AutoCAD).
- Prior experience with electrical/electronics.
Data can only be transferred outside of the EEA on the basis of standards contractual clauses, to a country for whom an adequacy decision has been given by the European Commission or where the express permission of the data subject has been given. You have supplied us with your personal data in the process of applying for a position. Our client company may have personnel outside of the EEA who will review your data. We will apply the appropriate criteria in respect of the data transfer depending on the location of those personnel.
For further information on this role please contact Tommy McKeown on +353 86 0100903 / email@example.com
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