Thermo Fisher Scientific Business Analyst - Clinical Applications in Fremont, California

Job Description

When you join us at Thermo Fisher Scientific, you’ll be part of a smart, driven team that shares your passion for exploration and discovery. With revenues of $22 billion and the largest investment in R&D in the industry, we give our people the resources and opportunities to make significant contributions to the world.

How will you make an impact?

Are you a Scientist who is interested in working outside of the lab while applying your knowledge of clinical lab workflows? Do you have excellent customer-facing skills and a passion to surface real customer needs? Do you have a knack for translating complex items into easy to understand subject matters? Do you excel at authoring technical documents? If so, there is an opportunity to leverage your clinical/lab skills as a Business Analyst within our R&D team. This is an opportunity to help design and develop new software that makes an impact to patient lives.

As a Business Analyst - Clinical Applications, you will work with a highly motivated team dedicated to the development of cutting edge software products enabling Quality Control and medical diagnostics within a lab environment. The ideal candidate will be a team player who is passionate about delivering effective and customer-focused software products while working alongside Chemists, Molecular Biologists, and Engineers in a fast-paced environment. Should have a strong comfort level working with translating and defining technical user needs into software requirements.

What will you do?

  • Act as the Voice of the Customer (VOC) and translate user needs provided by Marketing and customers into software requirements for the Development team by soliciting, aligning, and incorporating feedback from diverse stakeholders.

  • Participate in cross-functional teams and effectively communicate difficult concepts at a high level, as well as the technical details, to various stakeholders within the organization.

  • Work with offshore team to understand technical requirements and communicate/collaborate with users to analyze customer needs and functional requirements.

  • Ensure a robust Design Control for new software product development per FDA and international guidelines by incorporating risk/compliance analysis.

  • Compile and ensure a robust Design History File for new software product development.

  • Develop and write Standard Operating Procedures for software product.

  • Lead the development of customer-facing documentation and training materials, e.g., user guides, training manuals, etc.

How will you get here?

  • Bachelor's degree plus 5 years of direct related experience; Life Science/Engineering discipline is preferred.

  • Proven skills to drive project progress while working to mitigate risks to project schedules and timelines.

  • Must be highly collaborative, have the ability to work within a diverse team, and contribute to a supportive, positive work environment both within the team and in the greater site-wide community.

  • Experience in authoring technical and released documentation is required.

  • Proven track record of capturing requirements that meet customer needs.

  • Strong analytical skills required, including a thorough understanding of how to interpret customer business needs and translate them into application and operational requirements.

  • Set the foundation for designing high quality, flexible, scalable and maintainable software solutions.

  • Ability to work in a fast paced environment while being a self-starter, and able to work with minimal directions.

  • Excellent verbal and written communication skills.

  • PMP certification is a plus.

  • Understanding design control, FMEA/risk is highly preferred.

  • Knowledge of FDA regulations for software product development is highly preferred.

  • Understanding of software development life cycle (SDLC).

  • Familiarity with C# and cloud-based software desired.

  • Proficiency with Word, Excel, PowerPoint and Visio.

  • Understanding the workflow within an IVD lab environment is highly preferred.

At Thermo Fisher Scientific, each one of our 70,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer.

Apply today! http://jobs.thermofisher.com at http://jobs.thermofisher.com/

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

If you are an individual with a disability who requires reasonable accommodation to complete any part of our application process, click here at https://jobs.thermofisher.com/page/show/eeo-affirmative-action-statement#accessibility for further assistance.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.