We are seeking a highly skilled Senior Design Verification & Validation (V&V) Engineer to lead and execute V&V activities for the development of disposable kit products in a regulated medical device environment.
The ideal candidate will have deep expertise in Design Controls, strong statistical analysis skills, and proven ability in technical report writing.
This role will partner with cross-functional R&D teams to ensure that all design verification and validation activities meet regulatory standards, product performance requirements, and project timelines.
Design Controls Knowledge – particularly Design V&V
Statistical Background – DOE, sampling plans, acceptance criteria, capability analysis
Technical Report Writing – clear, concise, and compliant documentation
Lead and execute Design Verification and Validation activities for disposable kit development.
Define test plans, methodology, equipment, and resources to support V&V activities.
Design and review Design of Experiments (DOE) to support product evaluation and process development.
Establish acceptance criteria and sampling plans using statistical methods for verification and validation.
Develop and champion best practice guidelines for V&V processes across the R&D team.
Perform and document root cause investigations in collaboration with hardware, software, application, manufacturing, and biology SMEs.
Support Risk Analysis activities (ISO 14971) and contribute to the Risk Management File.
Review, revise, and draft user and product specifications as needed.
Ensure on-time project delivery and maintain clear communication with stakeholders.
Education & Experience
Bachelor’s degree in Engineering or a related scientific field; advanced degree preferred.
6–10+ years in designing, developing, and manufacturing plastic disposable kits for regulated industries (Class II/III medical devices preferred).
Technical Expertise
Proven experience with design verification of disposable kits involving manufacturing processes such as:
Injection molding, compression molding, tube extrusion, thermoforming
Heat staking, ultrasonic welding, laser welding, snap-fitting, UV gluing, solvent bonding
Experience with test method validation (DOE, OQ, Gage R&R), mechanical testing (pull/peel, burst, leak, dye, bubble tests), and packaging/stability studies (ISTA, pre-conditioning, aging).
Familiarity with ISO Class 7 & 8 cleanroom operations.
Knowledge of materials biocompatibility (ISO 10993, USP 88), leachables & extractables (E&L), and sterilization techniques (a plus).
Strong background in statistical data analysis (Minitab or equivalent).
Experience with process capability analysis and TMV (Test Method Validation).
Soft Skills
Strong problem-solving and analytical thinking.
Excellent verbal and written communication skills.
Ability to work cross-functionally in a fast-paced, regulated environmen