Senior Process Development (Biomedical) Engineer

SKILLS AND ACHIEVEMENTS

• Communication: I have lead and worked on several team projects and assignments, which have developed my negotiation and persuasion skills. I have strong oral and written presentation skills and I am accustomed to presenting to all organisational levels – operator, engineer, management, director, VP and CEO. My manager and supervisor communication skills have been developed by providing professional and technical guidance to the engineers, technicians and operators that have reported to me.

• Computers: I have experience using Microsoft access, PEMAC, SAP, Oracle and PDM and have an excellent working knowledge of Syspro, Minitab, Solidworks, AutoCAD, Microsoft Word, Excel, Powerpoint and Project.

• Additional skills and achievements:

- Full Irish driving licence and International driving license.

- NCLA course: Harnessing Laser Energy for Manufacturing, National University of Ireland, Galway.

- Process Validation course: SQT Training LTD, Cork, Ireland.

- HAZOP course: ICHEME, Cork, Ireland.

- Leadership course – IMDA, Galway, Ireland.

- Internal Auditing course: GKC, Galway, Ireland.

- Measurement and Calibration course: NSAI National Metrology Laboratory, Galway, Ireland.

- Designing Cardiovascular Devices: Begin with the body in mind – IMDA, Galway, Ireland.

EDUCATION AND QUALIFICATIONS

• 2010-2011 (part-time): National University of Ireland, Galway.

- Specialist Diploma in Environmental Sustainability, graduated with an honours post-graduate diploma.

• 1999-2003: National University of Ireland, Galway.

- Bachelor of Biomedical Engineering, graduated with an honours degree.

• 1994-1999: Dominican College, Taylor’s Hill, Galway, Ireland.

- Secondary education, graduated with advanced level certificates.

WORK EXPERIENCE

Senior Process Development Engineer: Jan 2010 – Present, Cappella Medical Devices Ltd., Galway, Ireland.

I was promoted from product engineer to a senior engineering position.

• Engineering Process/Product Support

- Lead process and product engineer for the Sideguard® Sidebranch Stent and Delivery system which includes the delivery system catheter balloon manufacturing, nitinol stent processing and product labelling & packing.

- Introduction of a stretching process for balloon and sheath tubing as a process improvement for the moulding area including calibration & validation of the process and submission to the regulatory body for approval.

- Equipment design of automated balloon moulding machine including URS and introduction of this machine to production which involved feasibility work to determine machine parameters and full calibration & validation (IQ, OQ, PQ, PPQ) of the balloon and sheath moulding processes.

- Experience of working in an environment regulated by ISO 9000 and 13485, including internal and external auditing. I am responsible for the manufacturing department during TUV and DEKRA audits.

• Research & Development/Process Development

- Senior engineer responsible for the delivery device on the introduction of new products, including test method validation and product testing for concept feasibility, prototype designs and design verification.

- Project leader for major design change projects including the addition of a bar code to the product labelling and addition of a secondary markerband to the delivery device. These high-profile design & development projects included concept, feasibility, prototyping, pre-clinical animal trials, design verification & design validation, process validation, transfer to production and commercialisation. Risk management (use, design and process FMEAs) was evaluated and regulatory submission/approval was required as part of the implementation of these projects.

- Team member for several design change projects including change of the delivery device sheath material design, introduction of additional product codes and extension of product shelf life.

- Design of three new balloon and sheath sizes for the expansion of product sizes for the catheter delivery device.

- Team member for production move to a larger facility including ISO class 8 cleanroom validation, planning and re-location of equipment, re-calibration & IQ of equipment, re-validation assessment & OQ, PQ, PPQ validations.

- Team member for the introduction of an environmental monitoring programme for ISO class 8 cleanroom. This included microbiological & particulate testing and validations as a result of a risk assessment that was completed.

- Redesign of product labelling and packaging including artwork and material changes for a new product label & carton and the introduction of a new product hoop label. I updated the label printing process to include a secure database for label text which required a software and process validation.

• Product Specialist

- Review diagnostic angiograms and analysis of customer feedback requiring updates to the risk management report.

- Support sales team by training industrial specialists and providing clinical support for cardiologists in Europe.

- Literature reviews and communication with cardiologists to develop clinical plan for drug eluting stent project.

Product Engineer: Jan 2009 – Jan 2010, Cappella Medical Devices, Galway, Ireland.

I was hired for a senior position to cover maternity leave for the Production Manager as well as perform the role of lead product engineer for the Sideguard® Sidebranch Stent and Delivery system.

• Production leader and supervisor for a team of operators, engineers and technicians.

- Responsible for increasing production output and yields by improving process flow, hiring additional operators and introducing process aids and process improvements.

- Introduced the ERP software Syspro to manufacturing for inventory management and work order generation.

- Responsible for sourcing suppliers, completing vendor approvals and carrying out vendor audits.

- Enhanced part specifications and generated incoming inspection requirements for receiving of parts.

- Generation, implementation and completion of DNCRs and CAPAs to ensure compliance with the quality system.

- Team leader for design change for balloon tubing material involving extrusion DOE studies, SPC improvements, material changes & process validations.

- Generation of calibration procedures and completing calibration of manufacturing and test equipment.

- Responsible for routine maintenance of manufacturing and test equipment.

Manufacturing Engineer (Contractor): Sept 2008 – Jan 2009, Boston Scientific Ireland LTD, Galway, Ireland.

Contracting Manufacturing Engineer in the Percutaneous Transluminal Angioplasty (PTA) department.

• Manufacturing engineering line support, problem solving, individual and team projects for catheter products.

- Lap weld yield improvement involving tooling redesign and process re-validation.

- Redesign pouch sealer mounts – an ergonomic improvement.

Process Engineer: June 2006 – Sept 2007, Millipore Corporation, Carrigtwohill, Co. Cork, Ireland

Process Engineer in the bioprocess department, manufacturing membrane for filtration devices. I developed a good knowledge of polymer casting, hydrophilisation and the chemistry reactions involved in the immersion casting process.

• Responsible for dealing with process, product and quality issues to achieve long term solutions. This included technical support and contact with external Millipore personnel and suppliers to deal with process and product issues.

• Developed and updated SOPs and process guidelines as required by improvements that I implemented in production.

• Responsible for dealing with customer complaints from our filter device plants. This involved reviewing and analysing our process results to identify trends and eliminate the weaknesses.

• Sourced a new supplier to find a replacement raw material for a chemical resin required for the coating of the membrane. This involved concept feasibility, DOE studies and process trials and as leader of this high profile design change project, I co-ordinated validation and qualification in several Millipore plants both in Ireland in the USA.

Manufacturing Engineer: February 2004 – June 2006, Boston Scientific Ireland LTD, Galway.

Manufacturing Engineer in the cardiovascular department responsible for the Stent Delivery System area.

• As core team leader, I was primarily responsible for the yield on three catheter production lines which were running 24/7 in a class 8 cleanroom environment. I introduced process and equipment improvements in order to increase production yields and worked closely with the production core team to resolve process, quality and machine issues.

• Using Six Sigma tools to solve both daily process issues and long term yield issues, I have developed strong analytical and problem solving skills which have been demonstrated in Yellow and Green Belt team projects.

• Project leader for a project to redevelop a laser weld process to improve the process yield which required process validations and submissions to the FDA and TUV for approval.

• Project leader for a Value Improvement Project: A design and process change to change the product mandrel for all the delivery systems. The total savings was valued at over €300,000/yr.

• As a member of the Lean Manufacturing Team, I developed and implemented line layouts to improve efficiency and production outputs. This project involved working with the Facility and Industrial Engineering departments.

• I made improvements to the top assembly routings which greatly increased production efficiency. This involved creating new parts, BOMs and routings for sub assemblies and updating the existing top assembly BOMs and routings. I co-ordinated with Quality and Documentation Services to plan and implement this project.

Manufacturing Engineer (Co-Op): April 2002 – September 2002 Boston Scientific Ireland LTD, Galway.

Work experience for my university degree as a Manufacturing Engineer in the cardiovascular department.

• Introduced new equipment for a second production line including equipment installation, maintenance routines, calibration/certification requirements, IQ/OQ and software validations.

• Final Year Project: To investigate if the consumption of razor blades could be significantly reduced throughout the company by introducing cryogenically treated razor blades.

INTERESTS AND ACTIVITIES

I enjoy salsa dancing, swimming, tennis, playing the guitar, music & films, surfing and snowboarding.

REFERENCES AVAILABLE UPON REQUEST

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