Engineering - Engineer - Validation (Senior Level)

TechDigital Group; Marlborough (MA); On-site; USD 80,000 - 120,000; Full time

Job summary

An established industry player is seeking a seasoned professional with extensive experience in Design Verification and Validation. This role involves deriving test requirements, executing tests, and ensuring compliance with regulations in the development of innovative disposable products for a regulated market. The ideal candidate will possess a Master's degree and a strong background in statistical data analysis, project management, and hands-on testing methodologies. Join a dynamic team where your expertise will contribute to the advancement of high-quality medical devices, fostering innovation and excellence in product development.

Qualifications

• 7+ years in Design Verification and Validation for regulated industries.
• Experience with ISO13485, FDA regulations, and statistical analysis.

Responsibilities

• Define test plans, execute tests, and analyze results for design verification.
• Lead root cause analysis and develop guidelines for verification activities.

Skills

Test method validation

Design Verification and Validation

Statistical Data analysis

Root cause analysis

Project management

Communication skills

Education

Master's degree in Engineering or related field

Tools

Gage R&R

Design of Experiments (DOE)

Job description

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

3 must haves

1. Test method validation/GageR&R
2. Design Verification and Validation
3. Statistical Data analysis

What you will do:

1. 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 modelling or qualitative/quantitative testing, evaluate the performance according to URS, SRS (design inputs and outputs).
2. 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.
3. Perform Test Method Validation and Equipment Qualification.
4. Lead root cause analysis, investigations on test failures through Verification & Validation activities.
5. 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:

1. 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). Mater's degree or equivalent experience in related engineering or scientific fields (mechanics, micro-mechanics, materials...).
2. 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.
3. Demonstrated experience in defining and managing Design Verification and Validation plans, test execution, results risk mitigation, statistical data analysis and reports.
4. Experience in Design 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.
5. 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...).
6. 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.