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Senior Manager, Clinical Software Development

Company: Thermo Fisher Scientific
Location: South San Francisco
Posted on: July 22, 2021

Job Description:

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $25 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them.

How will you make an impact?

You will be a part of the fast-growing field of Clinical Diagnostics developing IVD software product for molecular diagnostics based on real-time PCR technologies. Your interaction and collaboration with a talented team of assay, reagents, software, hardware designers and manufacturing will revolutionize healthcare through high throughput diagnostic systems. Thermo Fisher Scientific Inc. has played a pivotal role in the COVID-19 pandemic with the TaqPath COVID-19 Combo Kit for testing SARS-CoV-2. We continue to innovate and provide new solutions for the pandemic and we need your talent to help save lives.

What will you do?

  • Manage a team of software project managers and business analysts
  • Develop and expand team skills and provide leadership in career development
  • Project management by aligning skills with tasks, scheduling and prioritization
  • Develop standards and process for operations
  • Work closely with team to accomplish goals and review progress
  • Manage upwards by aligning management goals and expectations
  • Produce and update roadmap for RUO to EUA to 510k
  • Develop strategies to minimize validation requirements for customers

What will your team do?

  • Provide software project management continuity for IVD software projects
  • Develop and maintain software development schedules
  • Complete design history file
  • Support IVD submissions to global regulatory agencies
  • Support product roll out
  • Provide post market customer and regulatory support
  • Manage offshore and external development teams
  • Manage the sharing of resources across projects
  • Maintain IVD standards and PCP process
  • Collaborate and communicate with various functional teams and business units

How will you get here?

  • Bachelor's in Biology, Chemistry, Engineering, Bioinformatics, Computer Science or related discipline; postgraduate degree (Masters, PhD) is highly preferred
  • 2+ years of experience in leading software teams in clinical diagnostics
  • 3+ years of software product development experience (biotechnology industry preferred)

Knowledge, Skills, Abilities

  • Software product life cycle
  • Agile software development and SCRUM
  • Risk management and hazard analysis
  • Requirements gathering and writing
  • Strong understanding of qPCR and amplification curve data
  • Prior experience with US-FDA 510k product development/submission, 21 CFR Part 11, and ISO 13485 is highly preferred
  • Ability to present and communicate clearly and concisely
  • Ability to work independently and in a team environment

Our global team of more than 75,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon. For more information, please visit www.thermofisher.com.

Apply today! 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.

Keywords: Thermo Fisher Scientific, South San Francisco , Senior Manager, Clinical Software Development, Other , South San Francisco, California

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