Design Quality Engineer

We are a technology-led healthcare solutions provider. We are driven by our purpose to enable healthcare organizations to be future ready. We offer accelerated, global growth opportunities for talent that’s bold, industrious and nimble. With Indegene, you gain a unique career experience that celebrates entrepreneurship, and is guided by passion, innovation, collaboration and empathy. To explore exciting opportunities at the convergence of healthcare and technology, check out www.Careers.Indegene.Com What if we told you that you can move to an exciting role in an entrepreneurial organization without the usual risks associated with it? We understand that you are looking for growth in your career at this point and we would love for you to join us in our journey and grow with us. At Indegene, our roles come with the excitement you require at this stage of your career with the reliability you seek. We believe in creating leaders of tomorrow and mentor our leads to help them grow and nurture them as people managers and account managers. We are a rapidly growing global organization and are scouting for the best talent for this phase of growth. With us, you are at the intersection of two of the most exciting industries of healthcare and technology. We offer global opportunities with fast-track careers while you work with a team that is fueled by purpose. The combination of this will lead to a truly differentiated experience for you. If this excites you, then apply below. Senior Design Quality Engineer - (Immediate Joiners or > 30days ) You will be responsible for: - Ensures that appropriate quality plans are made that include all stages of the life cycle of the product and support Quality Plan design. - Provides effective oversight of the execution of the Quality Plan, any Risk Management activities, and all design-related activities during the product/system lifecycle. - Validates key design inputs like usability, reliability, Performance, supportability, manufacturability, localizability, security, Privacy, serviceability, sustainability, and costs. - Performs assessment of product quality performance and post-market product quality analysis. - Uses post-market analytics and statistics to report on product quality performance in the field (provide feedback to manufacturing, suppliers, or design teams) and initiates field actions when enquired. - Ensure compliance requirements are met during design reviews, design Verification, validation, and design transfer. - Apply and Facilitate design for quality and reliability best practices (FMEA, robust design, V&V, RCA, Problem-solving). Your impact: About you: - Applied knowledge of appropriate global medical device or consumer product regulations, requirements, and standards (21 CFR Parts 820, ISO13485, ISO14971, MEDDEV, EU MDR, etc.). - Experience or understanding of Software or Hardware development, Verification and Validation, Risk management, RCA, Requirements Management, Design, and Usability. - Understand Sample Size Determination and Statistical Methods, Safety Risk Management (i.E ISO 14971), and Failure Modes and Effects Analysis (FMEA) / Fault Tree Analysis. - Understand a quality system and its development, documentation, and implementation with respect to domestic and international standards or requirements. - Understand the audit process including types of audits, planning, preparation, execution, reporting results, and follow-up. - Be able to develop and implement quality programs, including tracking, analyzing, reporting, and problem solving. Must have: - Bachelor’s Engineering degree with 5-7 years of related experience or Master’s degree with 3+ years of related experience -Mechanical/ Electrical/ Electronic or Equivalent Engineering - Engineering Degree or equivalent experience in the medical device industry - 3+ years’ experience with a medical device company preferably EQUAL OPPORTUNITY Indegene is proud to be an Equal Employment Employer and is committed to the culture of Inclusion and Diversity. We do not discriminate on the basis of race, religion, sex, colour, age, national origin, pregnancy, sexual orientation, physical ability, or any other characteristics. All employment decisions, from hiring to separation, will be based on business requirements, candidate’s merit and qualification. We are an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin, gender identity, sexual orientation, disability status, protected veteran status, or any other characteristics.