Software Development Manager I

Job Posted 3/21/2022
Bio-Rad Laboratories, Inc.
5731 W. Las Positas Blvd
Benicia, CA 94510
United States
Category BioTech
Job Description

Bio-Rad is looking for a Software Development Manager. The primary duty of this position is to manage a group of software business analysts.

 

Sets the standards for:

 


  • Software requirement gathering, analysis, and management.

  • Software documentation for regulatory (e.g., FDA) submissions.

  • Safety Risk Analysis for new software features.

  • Requirements Management Tools.

Responsibilities


  • Manage day to day activities of direct reports.

  • Develop, estimate, manage and prioritize the Backlog for multiple projects / platforms (as necessary).

  • Plan and track multiple projects’ requirements/specifications for completeness as well as implementation status.

  • Report on this status to management and Core Team(s). 

  • Design and configure Requirements.

  • Management (RM) tools as necessary.

  • Oversee the Safety Risk Analysis Process with the software team. 

  • Expert user of the System Hazard Analysis. 

  • Familiar with Usability Engineering Standards. 

  • Ensure all products both current and new are in compliance with our Design Control as well as ensure the team’s adherence to IEC-62304-2015. 

  • Act as a resource to Regulatory Affairs regarding software issues.

Qualifications


  • 10+ years related experience or equivalent combination of education and work.

  • Experience in supervision/personnel management, preferably in a related industry.

  • Experience in designing and developing requirements for clinical, life science, laboratory instrumentation or medical devices.

  • Project management, experience in related programs and systems.

 

Vaccination Requirement:

 

Due to the higher threat of more infectious and deadly COVID-19 variant strains emerging, Bio-Rad has a mandatory vaccination policy requiring its US employees to be fully vaccinated against COVID-19 as a condition of employment. New hires will be asked to upload their vaccination card into our electronic database hosted by ClearPass, who specializes in securing electronic medical information, within 3 days of their start date. With this policy, Bio-Rad joins a growing list of companies that are prioritizing sound science and available facts to best ensure the ongoing safety of its employees and the community.

 

About Bio-Rad:

 

Bio-Rad is a global leader providing a broad array of clinical diagnostics and life science research products. With a team of more than 8,000 employees and a global network of operations serving our customers, we help people live longer, healthier lives.

 

Bio-Rad was founded over six decades ago and has continued to provide the healthcare industry with innovative and useful products that help life science researchers accelerate the discovery process and medical diagnostic labs obtain faster, better results.

 

EEO/AA Employer/Veterans/Disabled/Race/Ethnicity/Gender/Age

 

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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