Design Verification and Validation (V&V) Engineer (ISO 14971)

MUST HAVE: Minimum 6 years of experience designing, developing, and manufacturing plastic disposable kit products for regulated industry (medical device, class II and/or class III).

• Duration: 12+ months – estimated to end 4/2026 (contract extension expectation)
• Type: W2 contract (Third-party or C2C "Corp-to-Corp" arrangements WILL NOT be considered for this role)
• Pay: Negotiable depending on direct-related experience
• Work Authorization: Must be currently in the United States with active employment authorization documents. Visa sponsorship is not available, now or in the near future, for this position.
• Shift: 1st shift

What you will do:

• Lead and execute Verification and Validation (V&V) activities for disposable kit development.
• Define test plans, methodology, test equipment, and resources to support design Verification and Validation activities.
• Set-up design of experiments (DOE) and/or review plan and results to support product evaluation and process development.
• Establish acceptance criteria and sampling plans through statistical analysis or qualitative and quantitative testing.
• Perform and document technical root cause investigations in collaboration with R&D hardware, software, application, manufacturing, biology, and disposable kit system matter experts (SMEs).
• Support Risk Analysis activities within the R&D team and contribute to product Risk Management File (RMF).
• Mitigate project technical risks, resolve issues, deliver on-time, and establish strong communications with internal and external stakeholders.
• Assist R&D team in assessing existing user and product specifications and revising or drafting new ones

Requirements:

• Bachelor’s degree or equivalent in related engineering or scientific fields (mechanics, micro-mechanics, materials...).
• Experience with medical device risk management and risk analysis (ISO 14971).
• Long lasting experience (e.g. 6-10+ years) in designing, developing and manufacturing plastic disposable kit products for a regulated industry (e.g. medical device, class II and/or class III).
• Experience in verification 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.
• Knowledge of materials biocompatibility (ISO 10993 and USP 88), leachable & extractable (E&L) evaluations and sterilization techniques is a plus.
• Expertise in test method validation (e.g. DOE, OQ, Gage R&R, ), mechanical testing (e.g. pull/peel test, burst test, leak test, dye test, bubble test,...), in packaging design, transportation conditions simulation (e.g. ISTA) and stability study (e.g. pre-conditioning, aging test,...).
• Familiar with disposable product manufacturing processes such as injection molding, compression molding, tube extrusion, thermoforming, heat staking, ultrasonic welding, laser welding, snap-fitting, UV gluing, solvent bonding and ISO class 7 & 8 cleanroom operations.
• Knowledge of statistical data analysis, methods, and tools (Minitab or equivalent).
• Experience with test method validation (TMV), Gage R&R and process capability analysis.

Important information: To be immediately considered, please send an updated version of your resume to [email protected].

*** (Kelly does not expense relocation/interview costs)**

Work Authorization: Must be able to work in the United States with current employment authorization documents without VISA status that require Visa sponsorship now or in the future.

In addition to working with the world’s most recognized and trusted name in staffing, Kelly employees can expect:

• Competitive pay
• Paid holidays
• Year-end bonus program
• Recognition and incentive programs
• Access to continuing education via the Kelly Learning Center