Job Description Summary

As directed by the Quality Manager/Sr. Quality Engineer, the Lead Software Quality Engineer is
responsible for representing the Unit Quality function regarding all activities associated with the
development and implementation of medical device and non-medical products incorporating
software/firmware. This person will handle projects and tasks from product inception through
product launch and maintenance and play an active role in the software development processes
to ensure products meet quality standards consistent with both Corporate and unit policies,
while meeting all design control and other regulatory requirements.

Job Description

1.    About BD

BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics, and the delivery of care. The company develops innovative technology, services and solutions that help advance both clinical therapy for patients and clinical process for health care providers. BD has 70,000 employees and a presence in virtually every country around the world to address some of the most challenging global health issues.

2.    About BD TCI

BD, a 125-year-old global medical device company has started its Enterprise Center in Bangalore, India called BD Technology Campus India (TCI). This Enterprise Center will be an integral part of the global network for BDX. It will have presence of R&D, Quality, Regulatory, IT and other functions. The center boasts of some of the brightest minds who work in a unique environment that fosters and supports ingenuity. BD TCI is dedicated to serving BD’s customers and patients thereby contributing its bit towards “advancing the world of health”.

3.    Position Summary

As directed by the Quality Manager/Staff Quality Engineer, the Senior Software Quality Engineer is responsible for representing the Unit Quality function regarding all activities associated with the development and implementation of medical device and non-medical products incorporating software/firmware. This person will handle projects and tasks from product inception through product launch and maintenance and play an active role in the software development processes to ensure products meet quality standards consistent with both Corporate and unit policies, while meeting all design control and other regulatory requirements.

4.    Educational Background

Bachelor’s degree in a technical discipline, preferably Computer Sciences, Information Technology, or other Software Engineering related discipline.

5.    Professional Experience

7-12 years of relevant experience.

6.    Job Responsibilities

• Provide coordination and guidance to cross functional teams to ensure software quality objectives are met for product software, manufacturing software, quality system software, and software technologies included or used in the creation or production of medical devices

• Identify software quality challenges and software quality improvement opportunities

• Reviews and approves project documentation including Software Development Plans, Software Requirements Specifications, Software Design Documents, Software Test Plans/Protocols/Reports

• Writes and leads risk management activities including risk management reports, software risk analysis, hazard analysis and risk management files.

• Support of the following, however, are not limited to:

  • Design Control o Software Lifecycle Process o Change Control o Risk Management

  • Identification of CTQ's

  • Manufacturing equipment Software validations/Computer system validations o Post Market Surveillance o Situation Analysis

  • CAPA - Root cause investigation and implementation of corrective/ preventive actions

• Ensures quality conduct of projects, including design, data summary and interpretation, report preparation and review adherence to applicable regulations

• Decisions, recommendations and results further the achievement of goals critical to organizational, program, or project objectives

• Implements and communicates the strategic and technical direction for the product/project team

• Identifies any issues that may delay product or project and recommends appropriate action to be taken

• May work under consultative direction toward predetermined long-range goals and objectives

• Creates and supports documentation

• May be assigned as core team or extended core team member

• Assist in audits for the products under review as needed.

7.          Knowledge and Skills

a.          Knowledge

• Good working knowledge of medical device regulations and standards

(21CFR820, ISO 13485, IEC-62304, IEC-60601, IEC-62366)

• Prior experience with Regulated software development - Class II / III medical device experience preferred

• Strong knowledge of Software Development Lifecycle Processes, Quality Engineering tools

• Understanding of Cyber Security requirements for medical device

              b.   Skills

• Excellent Project Management and technical writing skills.

• Strong critical thinking, analytical, problem-solving & Interpersonal skills.

• Ability to prioritize and multi-task many different forms of work input that are both strategic and operational in nature.

8.   Desired / Additional Skills & Knowledge (Not essential to the job but will be an advantage to possess)

• ASQ Certificate(s) desirable

• Knowledge of Agile development process and tools

• Design for Six Sigma

Primary Work Location

IND Bengaluru - Technology Campus

Additional Locations

Work Shift