Karolina Konczal
King's Lynn,United Kingdom
Summary
Trilingual and accomplished engineering professional with over 8 years of experience in the high-volume, fast-paced medical devices industry, specialising in inhalation drug delivery systems, injectables, and pMDIs. Demonstrates a consistent track record in delivering high-quality, compliant products through expertise in design control, robust design methodologies, and regulatory compliance to ISO 13485 and GMP standards. Skilled in supporting multi-disciplinary projects, creating and executing comprehensive project plans, and generating technical documentation including protocols, reports and risk assessments. Experienced in conducting human factors studies, participating in design reviews, and driving continuous improvements across laboratory, metrology, and quality assurance functions. Adept at stakeholder communication, with strong customer-facing and cross-functional collaboration abilities. Demonstrates a detail-oriented mindset that drives effective problem-solving and supports product development across the full lifecycle - from initial concept through to commercialisation.
Overview
5
5
years of professional experience
1
1
Certification
Work history
Product Engineer
Bespak
King's Lynn, Norfolk
06.2022 - Current
- Supported the development and maintenance of combination devices and drug delivery systems by applying design control and regulatory frameworks (ISO 13485, GMP).
- Refined 3D CAD models and design briefs for concept development and client proposals.
- Developed and maintained various technical documents, reports, protocols, risk assessments, DFMEA, PFMEA, and work instructions.
- Managed Engineering Change Requests (ECRs), Root Cause Analyses (RCAs), and quality notifications.
- Facilitated patient handling studies and usability testing in early product development phases.
- Supported validation and verification testing through the execution of design protocols and analysis.
- Interfaced with quality, regulatory, and customer teams to capture requirements and align project goals.
- Delivered effective stakeholder communications and chaired cross-functional review meetings.
- Contributed to continuous improvement activities in metrology, testing methods, and documentation practices.
- Coordinated with suppliers on material specification, tooling readiness, and production requirements.
- Executed validation and verification testing based on design protocols and analyses.
- Collaborated with quality, regulatory, and customer teams to align project goals.
- Coordinated supplier engagements regarding material specifications and production readiness.
Lifecycle Product Technician
Bespak (Recipharm)
King's Lynn, Norfolk
01.2021 - 05.2022
- Provided comprehensive support for product functionality, maintenance, and troubleshooting.
- Managed communication channels between internal and external customers, delivering regular updates and ensuring effective information flow.
- Liaised with internal and external stakeholders to coordinate and complete product specifications, Design History Files (DHF), Device Master File (DMF), Risk Assessments, and Root Cause Analysis throughout the product lifecycle.
- Contributed to commercial product support and quality control measures, ensuring high standards of product performance and reliability.
- Assisted in the development and implementation of process improvements to enhance product efficiency and effectiveness.
- Supported the creation and maintenance of technical documentation, ensuring accuracy and compliance with regulatory requirements.
- Collaborated with cross-functional teams to resolve complex product issues and implement effective solutions.
- Serving as a main technical contact person for Big Pharma customers.
Product Engineering Co-ordinator
Bespak (Recipharm)
King's Lynn, Norfolk
12.2019 - 12.2020
- Managed customer-proposed improvements, ensuring consistency across company systems and processes.
- Coordinated actions and specific elements of New Product Introduction (NPI) projects.
- Interfaced with stakeholders and functions to ensure timely delivery of actions and projects according to agreed plans.
- Managed SAP Master Data, build documentation, and associated paperwork for customer build requirements.
- Effectively fostered and managed communication channels between customers and the business.
- Provided high-quality support to senior development engineers, assisting in bringing products from concept to fruition.
Education
Bachelor of Engineering - Mechanical Engineering: Product Design and Development
Coventry University
Coventry 09.2024 -
Higher National Certificate (HNC) - Mechanical Engineering
Manufacturing Technology Centre
09.2021 - 08.2023
Bachelor of Business Administration - General Administration
John Paul II Catholic University Of Lublin
10.2010 - 06.2014
Skills
- SOLIDWORKS
- 6 Sigma tools
- MiniTab
- MS Office
- SAP
- Failure Mode and Effect Analysis (FMEA)
- Product lifecycle management
- Data-driven decision-making
- Stakeholder Communication & Technical Presentations
- Robust Design Methods (DOE, QFD)
- Change Control Systems (Design Changes, ECRs)
- Technical writing
- Project Management
- Adapting to new technologies
- Quality focus
Languages
English
Proficient (C2)
Polish
Proficient (C2)
Swedish
Intermediate (B1)
Certification
- Prince2
- Six Sigma
Affiliations
- Travel & Cultural Exploration
- Creative Ventures & Entrepreneurship
- Long-Distance Running & Fitness
Timeline
Bachelor of Engineering - Mechanical Engineering: Product Design and Development
Coventry University
09.2024 -
Product Engineer
Bespak
06.2022 - Current
Higher National Certificate (HNC) - Mechanical Engineering
Manufacturing Technology Centre
09.2021 - 08.2023
Lifecycle Product Technician
Bespak (Recipharm)
01.2021 - 05.2022
Product Engineering Co-ordinator
Bespak (Recipharm)
12.2019 - 12.2020
Bachelor of Business Administration - General Administration
John Paul II Catholic University Of Lublin
10.2010 - 06.2014
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