Sr Test Engineer - Senior Level

Our client, a leading Medical Devices Manufacturing Company is looking for Sr Test Engineer - Senior Level and This is for an initial duration of 10 Months Contract at Marlborough, MA

Job Title : Sr Test Engineer - Senior Level

Job Id : 24-04330

Location : Marlborough, MA

Duration : 10 Months Contract W2

Position Type : Hourly Contract Position (W2 only)

100% onsite yes, USA - Marlborough Results Way; Mon-Fri 8am-5pm

3 must haves

• Test method validation
• Verification and Validation
• Data analysis

What you will do :

• 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, assess through modelling or qualitative / quantitative testing, evaluate the performance according to URS, SRS (design inputs and outputs).
• 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.
• Mitigate project technical risks, resolve issues, deliver on-time and communicate effectively.
• Perform Test Method Validation and Equipment Qualification.
• Lead root cause analysis, 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.

Who you are

Long lasting experience (e.g. 7+ years) in 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).

• Mater's degree or equivalent experience in related engineering or scientific fields (mechanics, micro-mechanics, materials...).
• 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 plans, test execution, results risk mitigation, statistical data analysis and reports.
• Experience in V&V activities related to disposable kits for medical device application associated to 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), 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 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.
19 days ago