Test Method Validation Engineer
Marlborough, Connecticut
Employer: Compunnel
Industry:
Salary: Competitive
Job type: Part-Time
Description:
Responsibilities:
Write test protocol, setup design of experiments, execute tests, analyze results and document report for design verification and validation activities with focus on quality, compliance and execution rigor.
• Derive test requirements from the specifications, define test plan and methodology, estimate effort and resources plan to cover design verification and validation campaign.
• Establish acceptance criteria, sampling size, assess through modelling or qualitative/quantitative testing, evaluate the performance according to URS, SRS (design inputs and outputs).
• Develop good practice guidelines for performing disposables kit verification and validation activities and organize standardization and harmonization within the R&D disposables team.
• Mitigate project technical risks, resolve issues, deliver on-time and communicate effectively.
Who you are
• Master’s degree or equivalent in related engineering fields (mechanical, materials...).
• Minimum 5 year-experience in designing, developing and manufacturing plastic disposable kit products for regulated industry (medical device, class II and/or class III).
• Well-founded knowledge and practical experience of relevant regulations (ISO13485, FDA 21 CFR Part 820), specifically for the US and European market product submission. Demonstrated experience in defining and managing verification and validation plan, execution, statistical data analysis and report. Experience in verification activities related to disposable kits for medical device application associated to manufacturing processes as injection molding, compression molding, tube extrusion, thermoforming, heat staking, ultrasonic welding, laser welding, snap-fitting, UV gluing, solvent bonding.
• Strong organizational and communication skills in 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.
Education: Bachelors Degree
Additional client information:
Responsibilities:
Write test protocol, setup design of experiments, execute tests, analyze results and document report for design verification and validation activities with focus on quality, compliance and execution rigor.
• Derive test requirements from the specifications, define test plan and methodology, estimate effort and resources plan to cover design verification and validation campaign.
• Establish acceptance criteria, sampling size, assess through modelling or qualitative/quantitative testing, evaluate the performance according to URS, SRS (design inputs and outputs).
• Develop good practice guidelines for performing disposables kit verification and validation activities and organize standardization and harmonization within the R&D disposables team.
• Mitigate project technical risks, resolve issues, deliver on-time and communicate effectively.
Who you are
• Master’s degree or equivalent in related engineering fields (mechanical, materials...).
• Minimum 5 year-experience in designing, developing and manufacturing plastic disposable kit products for regulated industry (medical device, class II and/or class III).
• Well-founded knowledge and practical experience of relevant regulations (ISO13485, FDA 21 CFR Part 820), specifically for the US and European market product submission. Demonstrated experience in defining and managing verification and validation plan, execution, statistical data analysis and report. Experience in verification activities related to disposable kits for medical device application associated to manufacturing processes as injection molding, compression molding, tube extrusion, thermoforming, heat staking, ultrasonic welding, laser welding, snap-fitting, UV gluing, solvent bonding.
• Strong organizational and communication skills in 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.
Education: Bachelors Degree
Additional client information:
Created: 2024-06-29
Reference: SARDC4977585
Country: United States
State: Connecticut
City: Marlborough