Job Description
At Thermo Fisher Scientific, each one of our 100,000+ extraordinary minds has a unique story to tell. Join us and achieve our mission-enabling our customers to make the world healthier, cleaner and safer. You’ll be joining a hard-working, dedicated and motivated 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 chances to create significant impact to the world.
How will you make an impact?
The Business Analyst – SW NPI will work with a highly motivated team to develop of software products enabling Quality Control/medical diagnostics within a lab environment. The ideal candidate will be passionate about delivering effective and customer focused SW products while working alongside Chemists, Molecular Biologists, and Engineers in a fast-paced environment. Should have a strong capability working with translating/defining technical user needs into software requirements.
What will you do?
- Collaborate effectively within cross-functional teams, communicating product concepts both at a high level and in technical detail to various stakeholders.
- Act as a Scrum Master in the software agile process, translating user needs into design requirements for the Software Development team. Incorporate feedback from diverse customers to ensure alignment.
- Collaborate with and guide offshore team to understand technical requirements and analyze information needs and functional requirements from users.
- Ensure robust Design Control process for new software product development, adhering to FDA and international guidelines and conducting risk/compliance analysis.
- Support to compile and maintain the Design History File for new software product development, ensuring completeness and compliance.
- Develop and write Standard Operating Procedures for software products.
- Lead the development of customer-facing documentation and training materials such as user guides and training manuals.
Requirements:
- Bachelor’s degree in Engineering/IT/Medical Technology/Clinical Laboratory Sciences or related field, with at least 5 years of direct related experience.
- Strong collaborative skills and ability to work effectively within a team with varied strengths and in a supportive work environment.
- Experience in authoring technical/customer facing documentation.
- Proven track record of capturing requirements that meet business needs and lay the foundation for designing high-quality, flexible, scalable, and maintainable software solutions.
- Strong analytical skills, including the ability to interpret customer business needs and translate them into application and operational requirements.
- Ability to work in a fast-paced environment as a self-starter, with minimal supervision.
- Excellent verbal and written communication skills.
- Proven ability to drive project progress and mitigate risks to project schedules.
- PMP/SCRUM Master certification is a plus.
- Understanding of design control process and familiarity with FMEA/risk analysis is preferred.
- Knowledge of FDA regulations for software product development is highly desired.
- Familiarity with the software development life cycle (SDLC).
- Proficiency in Word, Excel, PowerPoint, and Visio.
- Familiarity with AWS, object-oriented programming, and cloud-based software is desired.
- Exposure to ASTM/HL7 Protocols and Interfacing is a Plus
Benefits:
We offer competitive bonus scheme, healthcare, company pension, and a range of employee benefits! Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation.
EEO/Reasonable Accommodation:
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.
Compensation and Benefits
The salary range estimated for this position based in California is $90,900.00-$136,350.00.
This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes:
- A choice of national medical and dental plans, and a national vision plan, including health incentive programs
- Employee assistance and family support programs, including commuter benefits and tuition reimbursement
- At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy
- Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan
- Employees’ Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount
For more information on our benefits, please visit: https://jobs.thermofisher.com/global/en/total-rewards