Prin Software Quality Engr

Responsibilities:

Create and maintain SW and FW quality and performance requirements and the related metrics

Contribute to test method creation , review and approve test protocols to support V&V activities for Software and Firmware team.

Leads risk assessments and develop/maintain risk management files for SW, FW, SOUP and Tools

Actively participate in product development cycle by ensuring that design control processes are followed, reviewing product project documentation and owning the closure of the defects.

Partner with cross functional teams and function seamlessly within the Global Quality team.

Lead resolution to post-market product defects, complaints, and/or safety issues

Lead adherence to processes for technical design reviews, code reviews and CCB (Change Control Board) reviews, active member of the Defect Review Board.

Own quality of technical design reviews, code reviews and CCB (Change Control Board) reviews.

Assess quality programs and systems with relation to standards such as IEC 60601-1 and IEC 62304 , ISO 13485 and ensure adherence to the standards

Drive SOP updates or creation of new processes based upon upcoming standards or process improvements

Assist in vendor audits to ensure the quality of the vendor deliverables , assist in internal audits and prepare the team for facing the audits

Create a culture of quality awareness/focus by mentoring junior engineers and conducting training sessions

Champion of product quality

Essential Qualifications:

Bachelor’s degree (or higher) in Software/ Computer Engineering, or equivalent.

12+ years of experience in an engineering role.

Expertise in various phases of SLDC and quality requirements/standards for medical device industry.

Hands on experience with risk analysis, risk management, requirements traceability, and Fault Trees or dFMEAS

Experience in conducting DHF Audits, Milestone review checks and process compliance audits

Strong verbal and written communication skills; ability to produce high-quality documentation.

Ability to work independently, self-starter and accountable, with sharp focus on quality and customer experience.

Ability to work in cross-functional and cross-cultural global teams; Ability to participate in early morning and/or late night calls; Ability to travel domestically and internationally as required

Nice-to-have Qualifications:

Experience working on embedded systems (Firmware development)

Working knowledge of Android, Java, C, C++

Knowledge on working using Agile methodologies preferably Scrum.

Skilled in project leadership practices including ability to balance risk, effectively influence diverse teams, and ownership of responsibility for outcomes

Experience with requirements management, version control, and issue tracking tools

Working knowledge Six Sigma