Sr Test Engineer - Medical Devices

Job Opportunity in Marlborough, MA

Join our dynamic team in Marlborough, MA, a vibrant location that offers a perfect blend of professional growth and quality of life.

This role offers the opportunity to work in a cutting-edge environment dedicated to the development of medical devices.

Job Details

• Job Id : 24-04882
• Location : Marlborough, MA
• Duration : 11 Months Contract W2
• Position Type : Hourly Contract Position (W2 only)
• Schedule : 100% onsite, Mon-Fri 8am-5pm

3 Must Haves

• Test method validation
• Verification and Validation
• Data analysis

What You Will Do

• Derive test requirements from specifications, define test plan and methodology, estimate effort and resources plan to cover design verification and validation campaign.
• Establish acceptance criteria, sampling, and assess through modelling or qualitative / quantitative testing, evaluating performance according to URS and SRS.
• Write test protocols, set up design experiments, execute tests, analyze 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.

Who You Are

• Long-lasting experience (e.g., 7 years) in Verification and Validation of processes with an emphasis on new part development.
• Experience in developing and manufacturing plastic disposable kit products for a regulated industry (preferred medical device, class II and / or class III).
• Master's degree or equivalent experience in related engineering or scientific fields (mechanics, micro-mechanics, materials, etc.).
• 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 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), 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.

Qualified candidates please send your word format updated resume at the earliest to :

• Pavan : [email protected] 732-272-0382
• Sangeeth : [email protected] 732-272-0281

Thank you,

Sunrise Systems Inc.