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Urgent! Verification & Validation Engineer Job Opening In Marlborough Massachusetts – Now Hiring LanceSoft Inc
Pay Rate: $52/Hour on W2.
Job Summary:
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
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Unlock Your Verification amp Potential: Insight & Career Growth Guide
Real-time Verification amp Jobs Trends in Marlborough, Massachusetts, United States (Graphical Representation)
Explore profound insights with Expertini's real-time, in-depth analysis, showcased through the graph below. This graph displays the job market trends for Verification amp in Marlborough, Massachusetts, United States using a bar chart to represent the number of jobs available and a trend line to illustrate the trend over time. Specifically, the graph shows 5752 jobs in United States and 107 jobs in Marlborough, Massachusetts. This comprehensive analysis highlights market share and opportunities for professionals in Verification amp roles. These dynamic trends provide a better understanding of the job market landscape in these regions.
Great news! LanceSoft Inc is currently hiring and seeking a Verification & Validation Engineer to join their team. Feel free to download the job details.
Wait no longer! Are you also interested in exploring similar jobs? Search now: Verification & Validation Engineer Jobs Marlborough Massachusetts.
An organization's rules and standards set how people should be treated in the office and how different situations should be handled. The work culture at LanceSoft Inc adheres to the cultural norms as outlined by Expertini.
The fundamental ethical values are:The average salary range for a Verification & Validation Engineer Jobs United States varies, but the pay scale is rated "Standard" in Marlborough Massachusetts. Salary levels may vary depending on your industry, experience, and skills. It's essential to research and negotiate effectively. We advise reading the full job specification before proceeding with the application to understand the salary package.
Key qualifications for Verification & Validation Engineer typically include Other General and a list of qualifications and expertise as mentioned in the job specification. Be sure to check the specific job listing for detailed requirements and qualifications.
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Before the Interview:To prepare for your Verification & Validation Engineer interview at LanceSoft Inc, research the company, understand the job requirements, and practice common interview questions.
Highlight your leadership skills, achievements, and strategic thinking abilities. Be prepared to discuss your experience with HR, including your approach to meeting targets as a team player. Additionally, review the LanceSoft Inc's products or services and be prepared to discuss how you can contribute to their success.
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