Anne O'Neill (PhD)
Midleton,Cork
Summary
Principal Engineer with a proven track record in leading site strategy for automation initiatives. Expertise in managing multi-million euro projects and developing strong business cases. Skilled in project coordination, strategic decision-making, and fostering collaboration. Focused on delivering innovative manufacturing solutions that improve operational efficiency.
Overview
19
19
years of professional experience
7
7
Certifications
Work History
Principal Engineer (Technical Innovation), Eng.
Stryker Instruments
Carrigtwohill, Cork
08.2022 - Current
- Ownership and oversight of site automation strategy and roadmap
- Successfully planned, designed and managed several multi million euro custom automation engineering projects.
- Analyzed & developed design requirement information for equipment or systems.
- Coordinated activities with suppliers, contractors, and Stryker departments.
- Fostered collaborative environment to enhance team performance and project outcomes.
- Managed headcount, forecasted budgets, and allocated resources for each project.
- Technical Lead for Manufacturing Line Product Transfer to European sister site
Senior Project Manager, Eng.,
Stryker Instruments
Carrigtwohill, Cork
11.2021 - 08.2022
- Managed re-design initiative for Colorado Needle, achieving successful product return following component stock depletion.
- Directed technical re-scoping for intricate packaging automation concept to propose an alternative viable and profitable project that received endorsement & advancement
- Coordinated dialogue between senior management, project team members, and equipment vendors to guarantee efficient communication throughout project timeline.
- Supervised project scope, timeline, and budget, adhering to company objectives.
- Assessed potential risks and formulated mitigation plans to protect project objectives.
- Coached team members in addressing obstacles encountered during project advancement.
Project Lead, Senior Staff, Quality
Stryker Instruments
Carrigtwohill, Cork
11.2020 - 11.2021
- Led successful introduction of tailored automation line for Colorado Micro-dissection Needle product family
- Managed and supported team of eight throughout all necessary factory acceptance testing, redesigns, FAT re-execution, commissioning, validation, and change management deliverables.
- Developed project plan outlining scope, goals and deliverables
- Assigned tasks to team members and monitored progress.
- Ensured compliance with established policies, procedures and standards within project scope.
- Facilitated regular team meetings to review progress and address challenges.
- Managed relationships with stakeholders to ensure clear communication.
Projects Staff Engineer, Quality
Stryker Instruments
Carrigtwohill, Cork
01.2019 - 11.2020
- Supported and provided direction to the team by utilizing team members' strengths, early identification of training needs, mentoring, prioritizing, and assigning work tasks that delivered a €3.1 million project.
- Collaborated and led an obsolescence (PLCM) initiative across multiple departments to reduce manufacturing complexity and deliver a cost avoidance of €1.6 million.
- Conducted thorough testing and validation of instruments to ensure compliance with standards.
- Collaborated with cross-functional teams to ensure successful delivery of projects.
- Assisted in troubleshooting issues reported by vendor during debug.
Senior Engineer, Quality
Stryker Instruments
Carrigtwohill, Cork
07.2014 - 11.2018
- Led Production Process & Control pre-FDA audt preparation stream for site 2018
- Executed gap analysis assessment and formulated remediation plan for site Leadership team on Manufacturing transfer line.
- Cultivated extensive expertise in Quality Operations and NC/CAPA via multiple rotations from 2014 to 2016
- Managed diverse 4-D problem-solving efforts to refine processes and bolster product quality.
- Proven expertise in data analysis and quality trending - recognized compliance and process discrepancies and escalated when further action required
- Awarded Stryker Validation Engineer Certification for doc review & approval
QA/RA Engineer
Teleflex OEM
Annacotty, Limerick
10.2012 - 07.2014
- Lead Internal Auditor 2013-2014
- Lead Quality Engineer across extrusions, diagnostic, and interventional catheter business units.
- Oversaw process validation deliverables for commercial launch of sterile valved introducer (2013)
- Led SCAR/SCAPA, product complaint investigations and change notifications for process changes.
- Realized €250K cost reduction through CIP initiatives in Extrusions business unit.
QA/RA Engineer
Nordson Medical (formerly Vention)
Boyle, Roscommon
10.2011 - 10.2012
- Delivered annual sterilization re-validation in collaboration with Steris for the angiographic catheter business (2102).
- Completed ISO 13485 Lead Auditor Qualification (IRCA).
- Supervised supplier product quality matters and completed vendor audits to meet vendor management obligations per ISO 13485.
- Managed customer complaint processes, product quality discrepancies, site CAPA assessments, and environmental in-depth root cause evaluations, instigating advancements to prevent issue repetition.
Quality Engineer II
Boston Scientific
Cork, Cork
10.2008 - 10.2011
- Quality lead for new product introduction (NPI) / product transfers in the Catheters business unit, 2008-2011.
- Responsible for the quality remit in the commercial launch of the Neuroform EZ Stent (US & EU, 2010).
- Coordinated comprehensive product transfer of Wingspan and Neuroform 3 Stent Delivery System to Cork site for U.S. and EU launch in 2011.
- Partnered with various sites and departments to produce essential documents during design verification and process validation phases of each project.
- Coordinated pre-audit preparations on new production lines for DEKRA and FDA on-site inspections.
- Documentation reviewer for equipment and automated system validation documents, process change control, line moves, incoming inspection procedures, first article, risk documents, etc.
Technical Specialist
Abbott Diagnostics
Longford, Longford
10.2006 - 10.2008
- Principal contact for Ferritin metabolic product assays.
- Supported equivalency testing and finalized pre-market documentation deliverables for product transfer approvals and entry into EU market.
- Provided scientific support to Technical Operations for microparticle and conjugate preparation issues.
- Conducted thorough investigations (DMAIC) to identify root causes of product non-conformances, SPC control limit breaches, material issues, outlier testing, and customer complaints.
Education
Ph.D. - Pharmacy
University of Nottingham
United Kingdom12-2006
Master of Science - Applied Biomolecular Technology
University of Nottingham
United Kingdom09-2000
Bachelor of Science - Biochemistry (Hon.'s)
University College Cork
Cork07-1999
Skills
- Innovative manufacturing concepts
- Process design for automation expertise
- Project coordination
- Quality Operations
- Validation
- GAMP 4 & 5
- Decision-making
- Risk assessment
- Team leadership
- Mentoring
Certification
Construction (Health, Safety & Welfare) Regulations Training (2025)
Timeline
Principal Engineer (Technical Innovation), Eng.
Stryker Instruments
08.2022 - Current
Senior Project Manager, Eng.,
Stryker Instruments
11.2021 - 08.2022
Project Lead, Senior Staff, Quality
Stryker Instruments
11.2020 - 11.2021
Projects Staff Engineer, Quality
Stryker Instruments
01.2019 - 11.2020
Senior Engineer, Quality
Stryker Instruments
07.2014 - 11.2018
QA/RA Engineer
Teleflex OEM
10.2012 - 07.2014
QA/RA Engineer
Nordson Medical (formerly Vention)
10.2011 - 10.2012
Quality Engineer II
Boston Scientific
10.2008 - 10.2011
Technical Specialist
Abbott Diagnostics
10.2006 - 10.2008
Ph.D. - Pharmacy
University of Nottingham
Master of Science - Applied Biomolecular Technology
University of Nottingham
Bachelor of Science - Biochemistry (Hon.'s)
University College Cork