Philips Software Design Quality Engineer India, Karnataka, Bengaluru 386483560
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Job Description
This involves being a confident advisor on quality and reliability engineering topics.
You are responsible for
Ensure that appropriate project plan and quality plans are made that include all stages of the product’s lifecycle, targets and strategy for a robust software products development.
Validates key design inputs including requirements, specifications, useability, reliability, performance, supportability, manufacturability, localizability, safety, security, privacy serviceability, sustainability, and costs.
Provides effective oversight during the execution of the Quality Plan and any risk management activities, and of all design related activities during the lifecycle.
Contribute during design and development to identify critical quality attributes (CTQ, CTS) and ensure that appropriate mitigations and design controls are applied to mitigate the risks.
Facilitate design failure mode and effect analysis to identify failure modes early in the design and development process and apply design, manufacturing and inspections to mitigate the risks.
Ensure with objective V&V evidences that design output meets the design input.
Leading quality related problem solving with the cross functional teams
Using post-market data for analytics and statistics to report on the product’s performance in the market (provide feedback to manufacturing, suppliers, or design teams) and initiate field actions when required.
Act as a single point of contact (person assigned to) for project team(s); you’re responsible to ensure the product’s design quality relatedrequirements/criteriaare complete and meet the quality standards for every project milestone.
Make substantial contribution to integrate reliability engineering activities with the medical device development activities.
Effective oversight of project deliverables and provide quality input, including safety, efficacy, regulatory. Facilitate the product defect investigations and actions during defect management review meetings.
Participate in audits and regulatory inspection as design quality SME and guide other cross-functional stakeholders on technical aspects and audit conduct.
To succeed in this role, you should have the following skills and experience
Specific skill requirements for this role include:
Bachelor’s engineering degree with 12 years / Master’s degree with 10+ years of experience; in Software Engineering , quality engineering, SW Quality- or Reliability Engineering role in the medical or aerospace industry.
Software testing experience will be an added advantage
Ability to define detailed software quality and reliability plans for new medical product developments to ensure those are safe, effective and reliable.
Ability to contribute to Risk Management and lead FMEA activities for new products and assurance that control measures are translated in appropriate (critical) requirements.
Strong exposure to application of Design Controls; ability to do thorough Design Reviews during new product development to ensure robust designs that further improve patient safety and product quality.
Ability to partner with V&V teams to assure thorough Verification, Validation and Useability testing.
Analyze development and field data for Product Safety, Quality and Reliability performances and areas for further improvements of Product design and related development processes.
Well conversant with statistical data analysis, regressionmodeling,reliability growth assessment and other quality techniques
Experience with adequate and accurate review of DHF and DMR documents.
Understanding of global medical device regulations, requirements, and standards, such as 21CFR820, ISO13485, EU MDR, IEC 62366, IEC 62304 and ISO 14971.
Experience with working in multidisciplinary teams in a high-tech R&D environment.
Effective interpersonal, written and oral communication skills expected.
Ability and willingness to work onsite
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