Qualitest is looking for a Senior Verification to join our onsite team at Herculas, CA
This role is 5 days onsite.
Must haves:
1. Education: BS in Biomedical Engineering. MS in Biomedical Engineering or equivalent experience.
2. 5-10 years’ experience in the engineering/development of complex integrated systems comprised of electromechanical, fluidics and/or assay/chemistry subsystems. Ideally in the life sciences / diagnostics industry or equivalent experience in other industries. Should have full product development cycle experience with demonstrated commercial success of the product in the field.
Job Responsibilities:
•Establish, maintain, and execute on the system design Integration/Verification plan for a new medical diagnostic device and its subsystems (Test Cycles definition, Test Articles configurations, Design Requirements prioritization, Integration/Verification strategies),
•Develop just in time test protocols to support a traceable continuous integration design methodology (Test Method library, Sample Size determination, Risk Management mitigations),
•Lead test execution throughout the entire development effort across the medical diagnostic device and its subsystems (test Personnel capability & capacity, test Equipment development & qualification, test Vendors partnerships),
•Report test outcome with traceable objective evidence to support unbiased technical and project decisions (Defects report, Statistical significance, Technical/Design reviews, Regulatory Agency/Notified Bodies submissions),
•Ensure objective evidence traceability throughout the entire product development lifecycle (Raw data & records retention, Quick access to multiple layers of information, Design History File).
•Champion the adoption and execution of a Shift left strategy through System Design Integration/Verification process improvements and state-of-the-art best practices (Design for Six Sigma, Continuous Integration tools, LEAN management, Design Control),
•Leverage a global talent pool (France, Switzerland, USA) to optimize project testing activities quality, cost & duration based on Design Modules reuse.
•Provide technical leadership and knowledge of engineering principles and their application to developing cost- effective, reliable, and high-quality test methods that include elements of microfluidics, optics, thermal transfer, nucleic acid amplification, and robotics.
•Eventually be able to lead a systems Integration/Verification team and implement functional management processes and tools to monitor progress of engineering deliverables across the portfolio.
What You Bring:
•Education: BS in BioMedical Engineering. MS in Biomedical Engineering or equivalent experience.
•5-10 years’ experience in the engineering/development of complex integrated systems comprised of electromechanical, fluidics and/or assay/chemistry subsystems. Ideally in the life sciences / diagnostics industry or equivalent experience in other industries. Should have full product development cycle experience with demonstrated commercial success of the product in the field.
•5+ years’ experience with hands on laboratory testing execution covering a large variety of scientific/engineering tools/equipment, test methods/design of experiment and outcomes at various stage of product maturity.
•Experience working in a regulated industry, ideally with IVD experience, QSR/ISO regulations (e.g., ISO 13485, IEC 62304) & standards and risk management (ISO14971).
•Excellent problem-solving, organizational, analytical, and critical thinking skills including high discretion/judgment in decision making. Ability to foresee, plan and manage risks within current project and/or technology
•Ability to interact professionally with all organizational levels. Ability to work and excel within a fast paced, dynamic, evolving and changing work environment.
Benefits
Why QualiTest?
Be a part of a company who strives to support for diversity and inclusion in the workplace – we are one, we are many at Qualitest. Celebrate culture, share knowledge with engineers from around the globe, and inspire each other through our differences. We have more than 40% women and around 120 different nationalities. Local and global opportunities – we offer you internal rotation and international mobility opportunities to grow your career. Clear view of your career and progression with the company – Qualitest is growing massively (since 2021 – tripled our employees base – we now have more than 8,000 engineers) and giving you the opportunity to grow with us. Work hard and play harder with our flexible and casual culture. Take a break from work and join an employee event, or enjoy the amenities and games provided from one of our Employees Centers.Save your earnings and prepare for your future by enrolling in our 401k plan where Qualitest will match your contributions accelerating your savings plan. Take care of health with enrollment into one of our competitive healthcare benefits. Qualitest will match towards your HSA if you choose to participate. Never stop experimenting and learning with QCraft – our Learning & Development platform: 50,000+ courses, 300+ virtual labs, mentorship and leadership programs, professional tribes, sponsored certifications, and much more. Stay active and get rewarded with our Corporate Wellness Program. We pay your Gym membership and giving you opportunities to Earn additional vacation times for attendance the gym! Earn bonuses via our Client Referral and Employee Referral Program’s. Refer and earn – tap your network for net-worth. We recognize our employees work via our Qudos platform - You can earn bonuses and spot awards by celebrating your and your peers’ achievements. Planning a vacation? Looking for car insurance? Get access to Qualitest Employee Perks for discounts on anything from travel to electronics. With so many offerings the savings are endless! A Competitive pay, the salary range for the role is $100,000 - $110,000. Intrigued to find more about us? Visit our website at https://www.qualitestgroup.com/ If you like what you have read, send us your resume and let’s start talking!