Senior Validation Engineer / Measurement System Analysis – Medical Technology

Project overview

For our client, an established medical technology company in Baden-Württemberg, we are looking for an experienced freelancer for method and test method validation. You will be involved in two ongoing projects. You will independently analyze, evaluate, and validate quality-critical measurement and testing procedures and document the results in an audit-proof manner.

Responsibilities

Project 1: Test rig for air bubble detection

Project 2: Process and test strategy for a PEEK component

Mandatory Requirements

Desirable

Framework Conditions

Interested?

Send me your current profile with your hourly rate and availability. If you have questions first, feel free to contact me directly.

• Analysis and evaluation of a camera-based detection method
• Definition of the validation strategy, including relevant parameters and acceptance criteria
• Evaluation of repeatability, reproducibility, and influencing factors
• Technical support, evaluation, and documentation of the validation
• Analysis of the process chain from PEEK milling and laser processing to the measurement and test strategy
• Evaluation of tactile and optical measurement methods as well as contrast and homogeneity measurements
• Verifiable assurance and documentation of the process and test strategy for a planned process relocation
• Not part of the assignment: the validation of the new laser process
• Several years of practical experience in method or test method validation, ideally in medical technology
• Sound knowledge of MSA, Gage R&R, measurement uncertainty, and statistical analysis
• Experience in designing, conducting, and documenting validations independently
• Experience with complex technical measurement, testing, or manufacturing processes
• Audit-proof documentation in a regulated environment (e.g., ISO 13485)
• Structured, analytical, independent, and solution-oriented way of working
• Available 2-3 days per week, approx. 50% on-site
• ISO 13485, ISO 14971, Process Validation (IQ/OQ/PQ)
• Optical measurement systems, image processing, camera-based detection
• Tactile metrology and densitometry
• PEEK, milling, and laser processes
• FMEA, root cause analysis, DoE, experience with process relocations
• Start: January 15, 2027
• Duration: expected until the end of April 2027, extension possible
• Workload: 2-3 days per week, a total of approx. 280 hours
• Location: Baden-Württemberg, approx. 50% on-site (more at the beginning of the project), otherwise remote
• Language: German

Project details

• Start: 2027-01
• Duration: 4 Monate
• Remote: hybrid
• Location: Baden-Württemberg, Deutschland, DE
• Languages: German