Overview
On Site
Full Time
Skills
Test Plans
Modeling
URS
Software Requirements Specification
FOCUS
Regulatory Compliance
Root Cause Analysis
Materials Science
Mechanics
ISO 13485
ISO 9000
Management
Test Execution
Risk Management
Data Analysis
Medical Devices
Manufacturing
Injection Molding
Data Compression
Welding
UV
Test Methods
Design Of Experiments
OQ
Verification And Validation
Mechanical Engineering
Testing
Packaging Design
Communication
Fluency
English
Job Details
Responsibilities:
Requirements:
- Derive test requirements from the design specifications, define test plan and methodology, estimate effort and resources plan to cover design verification and validation campaign. Establish acceptance criteria, sampling, assess through modeling or qualitative/quantitative testing, evaluate the performance according to URS, SRS (design inputs and outputs).
- Write test protocol, setup design of experiments, execute tests, analyse results and document reports for design verification and validation activities with a focus on quality, compliance and execution rigor. Mitigate project technical risks, resolve issues, deliver on time and communicate effectively.
- Perform Test Method Validation and Equipment Qualification.
- Lead root cause analysis, and investigations on test failures through Verification & Validation activities.
- Develop good practice guidelines for performing disposables kit verification and validation activities and organize standardization and harmonization within the Disposables & Materials Engineering Team.
Requirements:
- Master's degree or equivalent experience in related engineering or scientific fields (mechanics, micro-mechanics, materials...).
- Long-lasting experience (e.g. 7+ years) primarily in Design Verification and Validation of processes with emphasis on new part development. Developing and manufacturing plastic disposable kit products for a regulated industry (preferred medical device, class II and/or class III).
- Well-founded knowledge and practical experience of relevant regulations (ISO13485, ISO11607, FDA 21 CFR Part 820), specifically for the US and European market product submission.
- Demonstrated experience in defining and managing Design Verification and Validation plans, test execution, results risk mitigation, statistical data analysis and reports.
- Experience in designing V&V activities related to disposable kits for medical device applications associated with manufacturing processes such as injection molding, compression molding, tube extrusion, thermoforming, heat staking, ultrasonic welding, laser welding, snap-fitting, UV gluing, solvent bonding.
- Hands-on experience with expertise in test method validation (e.g. DOE, OQ, Gage R&R), Design Verification & Validation, mechanical testing (e.g. pull/peel test, burst test, leak test, dye test, bubble test...), packaging design, transportation conditions simulation (e.g. ISTA) and stability study (e.g. pre-conditioning, aging test...).
- Strong organizational and communication skills in a multisite, multidisciplinary, multicultural matrix organization. Fluent in written and spoken English. Self-starter, hands-on, creative problem solver and solution developer when presented with conflicting requirements, business demands and technical risks/issues.
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