WICHTIGER HINWEIS FÜR BEWERBER!
Bio-Rad hat Berichte über Personen erhalten, die sich als Bio-Rad-Personalvermittler ausgeben, um Informationen von Bewerbern zu erhalten. Beachten Sie, dass sich Bio-Rad strikt an diese Einstellungspraktiken hält.

Design Validation Lead

  • 2025-36706
  • Hercules, California, United States
  • Forschung und Entwicklung
  • Hybridarbeit

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.

 

Fraud Alert: Bio-Rad has received reports of individuals posing as Bio-Rad recruiters to obtain information, including personal and financial, from applicants. Beware of these fake "recruiters" and job scams. Click here for more information on this scam and how to avoid it. #LI-AK1 #LI-Hybrid

Legal Entity: (USA_1000)Bio-Rad Laboratories, Inc.

 

 

Andere Personen angesehen

Field Application Spec II Feld Mittelstufe 2025-37027 Poland Poland Vertrieb/Marketing In order to support Bio-Rad and our successful future growth we are seeking a highly motivated and experienced individual to join our Sales team in Poland.The successful candidate will have the opportunity to make significant contribution within o...
Field Application Spec II Feld Mittelstufe 2025-37028 Warsaw Poland Warsaw, Poland Vertrieb/Marketing In order to support Bio-Rad and our successful future growth we are seeking a highly motivated and experienced individual to join our Sales team in Poland.The successful candidate will have the opportunity to make significant contribution within o...
Life Science Account Manager (Sales Area Campania / Molise) Feld Senior-Level / Manager 2025-37102 Segrate Italy Segrate, Italy Vertrieb/Marketing The account manager LSG professionally promotes and sells the specified range of Life Science products (Molecular Biology, Proteomics, Cell Biology) to accounts within the defined territory to achieve or exceed sales target acting as principal Bio...
Manufacturing Maintenance Supervisor Essentiell (vor Ort) Mittelstufe 2025-37110 Richmond California United States Richmond, California, United States Manufacturing / Produktion This position will supervise the Maintenance functions at the Richmond Chemical Plant, which produces process chromatography resins, liquid buffers, monomer solutions, oils, and other specialized life science products. The Maintenance Supervisor ...
Senior RA Specialist Essentiell (vor Ort) Einstiegslevel 2025-37034 Chaoyang District, Beijing China Chaoyang District, Beijing, China Quality and Regulatory Overview Strickly obey NMPA regulations and internal process to get products approved Work with DIV to get Chinese labelling ready after license approval Timely update PRER   How You’ll Make an Impact: -  Ensure products are registered acco...
Production Operator I Essentiell (vor Ort) Einstiegslevel 2025-37116 Santa Rosa California United States Santa Rosa, California, United States Manufacturing / Produktion Operator is responsible for inspecting, sorting and packaging injection molded parts in a fast-paced environment and in accordance with approved procedures. This includes work both in and out of a clean room environment.   This position is for a...
Production Technician - Temporary Essentiell (vor Ort) Einstiegslevel 2025-37140 Fort Worth Texas United States Fort Worth, Texas, United States Manufacturing / Produktion Performs a variety of routine, repetitive, physical and administrative tasks in a warehouse involving one or more of the following: receiving, putting away, storing, staging, kitting, picking, packing and shipping of materials, parts, supplies, eq...
Production Assembler I - Temporary Essentiell (vor Ort) Einstiegslevel ID 2025-36851.A Richmond California United States Richmond, California, United States Manufacturing / Produktion Operate filling and packaging mechanical equipment. Read and understand technical documents, such as diagrams, schematics, or other verbal or written instrucitons. Work with other members of the line or group in order to assemble products. Keep...
Technicien Méthodes / Projets II Essentiell (vor Ort) Mittelstufe 2025-37088 STEENVOORDE France STEENVOORDE, France Manufacturing / Produktion Notre site BIO-RAD situé à Steenvoorde (59) recherche un Technicien Méthodes/Projets II en contrat à durée indéterminée.   Rattaché(e) à l’ingénieur méthodes projet de la production, il(elle) effectuera des missions variées associées à l’industria...
FP&A Analyst Hybridarbeit Mittelstufe 2025-37070 Budapest Hungary Budapest, Hungary Finanz-und Rechnungswesen As a Financial Analyst at Bio-Rad, you will be a key part of the Global FP&A team, which is expanding as we centralize FP&A activities. You will partner with functional leaders to prepare budgets, forecasts, monthly financial analysis and reportin...
Sales Specialist - Life Sciences Feld Mittelstufe 2025-37105 South Melbourne Victoria Australia South Melbourne, Victoria, Australia Vertrieb/Marketing We currently have an excellent opportunity for a dynamic sales professional to join our Life Sciences team.   This Melbourne-based role covers the Western territory of Victoria and is responsible for selling and supporting Bio-Rad’s industry-le...
Juriste Relations Sociales Hybridarbeit Mittelstufe 2025-37065 MARNES-LA-COQUETTE France MARNES-LA-COQUETTE, France Personalwesen Vous êtes dynamique et passionné(e) ? Vous voulez participer à des projets d'envergure tout en assurant le respect des normes ? Vous souhaitez rejoindre une équipe structurée au sein d’une entreprise internationale ?   Rejoignez-nous en tant que...

Jetzt bewerben

Ich möchte künftig E-Mail-Mitteilungen von Bio-Rad erhalten.

Nicht du?

Danke

Treffen Sie einen Bio-Radian

Hören Sie mehr von einem Bio-Rad Mitarbeiter.

5_stars.png

„Bio-Rad rocks! ...“

Wissenschaftler (aktueller Mitarbeiter) Plano, TX

"Bei der Fortführung der Mission "Advancing Science and Improving Lives" (Wissenschaft vorantreiben und Leben verbessern) haben Sie die Möglichkeit, Beiträge zu Produkten zu leisten, die das Leben auf dem Planeten Erde auf sinnvolle Weise verbessern. Ich schätze das Arbeitsumfeld in Plano und die Tatsache, dass ich Teil eines Teams bin, das seine Leistung zu jederzeit erbringt."

Sie haben den gewünschten Job nicht gefunden?

Treten Sie unserem Talentnetzwerk bei! Erhalten Sie Stellenbenachrichtigungen, vierteljährliche Newsletter und andere nützliche Informationen von Bio-Rad. Sie können sich jederzeit wieder abmelden.

Nicht du?

Vielen Dank, dass Sie dem Talentnetzwerk von Bio-Rad beigetreten sind.