Design Validation Lead

As a Senior Staff Scientist. you’ll be right at the forefront of Bio-Rad's Clinical Diagnostics R&D Group – leading the design and validation of clinical diagnostics products across clinical immunology, immunohematology, diabetes and women's reproductive health applications. You'll also collaborate with a multi-disciplinary team of engineers and scientists, providing your technical knowledge and insights to ensuring alignment with product risk classifications and use environments.

How You’ll Make An Impact: 

• Own design validation deliverables such as plans, protocols, test execution, issues investigations and results reports for assigned projects. 
• Assess products conformity to user needs, intended use and use environments and support new products launch decision with clear and traceable objective evidence. 
• Bring customer centricity to development teams, influence them to integrate our user’s perspective in their design and testing, help them to focus on delivering a best-in-class experience and quality for our customers. 
• Bring multi-disciplinary teams of clinical, human factors, R&D, marketing and sales specialists together to face users and gather their feedback on design artifacts with various maturity.
• Leverage extensive clinical laboratory domain experience and strong relationships to adequately represent Bio-Rad products users’ perspectives. Train design teams to have a deeper understanding of clinical practices and set up representative use environments, laboratory workflows and routine practices. Champion the adoption and execution of customer centricity principles. 
• Lead the planning, design, coordination and execution of design validation studies in collaboration with clinical affairs, human factors, R&D, marketing and sales specialists to gather user feedback at various stages of product design. 
• Manage external vendors or test labs involved in validation testing as needed, execute well-coordinated internal and external testing activities. 
• Generate traceable and comprehensive objective evidence and documentation for design validation including plans, protocols, issues and reports supporting regulatory submissions strategies. 
• Analyze test results, identify and resolve complex user related and technical issues, identify areas for improvement and guide the product development team to prioritize feedback and improvements. 
• Leverage a global organization talent pool to optimize design validation testing activities quality, cost & duration. Drive risk-based validation approaches, ensuring alignment with product risk classification and intended use environments. 
• Communicate technical information clearly and concisely to both technical and non-technical audiences.

What You Bring:

• Education: MSc or Ph.D in Biomedical Engineering, Medical Biology or equivalent. 
• Work Experience: 
  • 8+ years’ experience in Design Validation for new In vitro diagnostics (IVD) or medical device (MD) products. Demonstrated a leading role in planning, execution and reporting of design control validation studies in R&D, clinical and human factors context. 
  • 3+ years’ functional or project management experience. Successful track record of bringing together and focus diverse teams, including customers, to lunch quality products. 
  • 2+ years’ hands on work in a clinical diagnostics or hospital environment. Successful track record of establishing and maintaining relationships with our customers. 
• Excellent listening, communication, and social skills with a user / customer centric mindset. Field experience is desirable. 
• Excellent observation, analytical, and critical thinking skills with data science fluency. Proficiency with Python, or Matlab preferred. 
• Ability to work and excel within a global, fast paced, and cross-functional work environment with a continuous learning mindset. 
• LEAN Green Belt or Black Belt certification is desirable.

Total Rewards Package: At Bio-Rad, we’re empowered by our purpose and recognize that our employees are as well. That’s why we offer a competitive and comprehensive Total Rewards Program that provides value, quality, and inclusivity while satisfying the diverse needs of our evolving workforce. Bio-Rad's robust offerings serve to enrich the overall health, wealth, and wellbeing of our employees and their families through the various stages of an employee’s work and life cycle.

Benefits: We’re proud to offer a variety of options, including competitive medical plans for you and your family, free HSA funds, a new fertility offering with stipend, group life and disability,  paid parental leave, 401k plus profit sharing, an employee stock purchase program, a new upgraded and streamlined mental health platform, extensive learning and development opportunities, education benefits, student debt relief program, pet insurance, wellness challenges and support, paid time off, Employee Resource Groups (ERG’s), and more! 

Compensation: The estimated base salary range for this position is $153,100 to $200,000 at the time of posting. Actual compensation will be provided in writing at the time of offer, if applicable, and is based on several factors we believe fairly and accurately impact compensation, including geographic location, experience, knowledge, skills, abilities, and other job permitted factors. This position is eligible for a variable annual bonus, which is dependent upon achievement of your individual objectives and Company performance.

Who We Are: For 70 years, Bio-Rad has focused on advancing the discovery process and transforming the fields of science and healthcare. As one of the top five life science companies, we are a global leader in developing, manufacturing, and marketing a broad range of high-quality research and clinical diagnostic products. We help people everywhere live longer, healthier lives. Bio-Rad offers a unique employee experience with collaborative teams that span the globe. Here, you are supported by leadership to build your career and are empowered to drive change that makes an impact you can see.  

EEO Statement: Bio-Rad is an Equal Employment Opportunity/Affirmative Action employer, and we welcome candidates of all backgrounds. Veterans, people with physical or mental disabilities, and people of all race, color, sex, sexual orientation, gender identity, religion, national origin and citizenship status are encouraged to apply.

Agency Non-Solicitation: Bio-Rad does not accept agency resumes, unless the agency has been authorized by a Bio-Rad Recruiting Representative. Please do not submit resumes unless authorized to do so. Bio-Rad will not pay for any fees related to unsolicited resumes.

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