Verification Validation Engineer

About Ascendion,Ascendion is a full-service digital engineering solutions company. We make and manage software platforms and products that power growth and deliver captivating experiences to consumers and employees. Our engineering, cloud, data, experience design, and talent solution capabilities accelerate transformation and impact for enterprise clients. Headquartered in New Jersey, our workforce of 6,000+ Ascenders delivers solutions from around the globe. Ascendion is built differently to engineer the next. Ascendion | Engineering to elevate lifeWe have a culture built on opportunity, inclusion, and a spirit of partnership. Come, change the world with us:Build the coolest tech for the world's leading brandsSolve complex problems - and learn new skillsExperience the power of transforming digital engineering for Fortune 500 clientsMaster your craft with leading training programs and hands-on experienceExperience a community of change-makers!Join a culture of high-performing innovators with endless ideas and a passion for tech. Our culture is the fabric of our company, and it is what makes us unique and diverse. The way we share ideas, learning, experiences, successes, and joy allows everyone to be their best at Ascendion.About the RoleJob Title: Verification Validation EngineerKey Responsibilities:Lead and execute V&V activities for disposable medical kits.Define test plans, methodologies, and acceptance criteria.Conduct DOE and mechanical testing (pull/peel, burst, leak, dye, and bubble tests).Develop best practices for V&V standardization.Collaborate with R&D, hardware, software, and manufacturing SMEs.Support Risk Analysis and Risk Management File (RMF) updates.Guide teams on IQ/OQ/PQ process validation and metrology best practices.Perform supplier audits and assess quality plans.Ensure compliance with ISO 13485, ISO 14971, and FDA regulations.Drive risk mitigation, project execution, and stakeholder communication.Minimum Qualifications:Bachelor's degree in Mechanical/Biomedical Engineering or related field.6-10+ years experience in disposable medical kit V&V.Expertise in manufacturing processes (injection molding, extrusion, welding, UV gluing, bonding).Hands-on test method validation (TMV), Gage R&R, process capability analysis.Familiarity with medical device risk management (ISO 14971).Knowledge of biocompatibility (ISO 10993, USP 88), sterilization, and extractable & leachable (E&L) studies.Proficiency in statistical data analysis tools (Minitab or equivalent).Desired Qualifications:Experience with Class II & III medical devices.Familiarity with FDA submission requirements.Ability to lead cross-functional teams and manage multiple projects.Location: Marlborough, MASalary Range: The salary for this position is between $80,000 - $90,000 annually. Factors which may affect pay within this range may include geography/market, skills, education, experience, and other qualifications of the successful candidate.Benefits: The Company offers the following benefits for this position, subject to applicable eligibility requirements: [medical insurance] [dental insurance] [vision insurance] [401(k) retirement plan] [long-term disability insurance] [short-term disability insurance] [5 personal days accrued each calendar year. The Paid time off benefits meet the paid sick and safe time laws that pertains to the City/ State] [10-15 days of paid vacation time] [6 paid holidays and 1 floating holiday per calendar year] [Ascendion Learning Management System]Want to change the world? Let us know.Tell us about your experiences, education, and ambitions. Bring your knowledge, unique viewpoint, and creativity to the table. Let's talk!

Created: 2025-03-02