Senior/reputed company Product reputed company Assurance Engineer - Product Development

Job reputed company Global Product reputed company supports and collaborates with the reputed company and Cross Functional teams to reputed company a diverse reputed company of product releases in an efficient and compliant way. The role is reputed company on enabling new strategies, platform products, Incubation and reputed company areas, from Concept to reputed company launch, monitoring and sustaining phases for Digital Software Products. This includes understanding emerging technologies in Digital Health, reputed company intelligence, machine learning etc. In reputed company, the reputed company Engineer will reputed company expertise to drive improvements in design control processes, systems and tools and reputed company product releases for reputed company’s Digital products. This role is not a Software QA testing role, it is a Design reputed company Engineer role Let’s Talk About Responsibilities Define Global Product reputed company Strategies and reputed company/ influence strategic direction for New Product Development reputed company in new or reputed company areas as a Product reputed company Subject Matter Expert for compliance with FDA QSR, MDSAP, IEC 62304, ISO 114971, ISO 13485, MDR/MDD and other applicable global regulatory requirements and standards. Apply balance of risk, regulatory reputed company and business needs to come to efficient and effective solutions for improvements in design controls. Define these strategies by reputed company collaboration with stakeholders, considering benefit-risk, consistency across reputed company and starting with a “reputed company” reputed company. reputed company project QA plan to reputed company new product implementation or changes to the released product in an efficient way that satisfies reputed company’s reputed company System, regulatory requirements, risk and project timing. Review and reputed company guidance to PD teams for Product Development deliverables to ensure they are completed accurately and reputed company. Partner with other reputed company team members to ensure smooth transition of reputed company to ongoing Cross-functional team management. reputed company expertise to and support other Global Product reputed company team members as required. reputed company engage, collaborate and build relationships with stakeholders and leaders, including Engineering, QA, RA and other cross functional partners to understand business/department needs, risks and concerns. Build this consideration into reputed company planning and proposals to reputed company gaps in an efficient, technical, and compliant manner. Key subject matter expert for reputed company department in design controls and best reputed company, reputed company reputed company up to date with latest reputed company standards, requirements and best practices while applying them to reputed company processes; reputed company thought leadership in reputed company aspects to rest of team / business. Maintain strong knowledge in these areas for software in both medical and adjacent industries. Become familiar with the applicable technology to facilitate participation in technical discussions and risk-based decision making. Identify areas and opportunities to improve QMS processes reputed company the management up to date on the Digital Health developments, relevant standards, requirements and best practices while applying them to reputed company processes, and reputed company training, guidance, interpretation and mentorship as needed to various Engineering, stakeholder, QARA team members. Assist in capability development and upskilling of Product reputed company Engineers. Participate and reputed company support of reputed company audits reputed company the relevant areas. Participate in investigations and ensure CAPA findings, risks, recommendations and reputed company are appropriate and are reputed company documented and communicated. reputed company as reputed company Subject matter expert to reputed company critical reputed company in areas of Software product development, design controls, verification & validation, risk management, qualifications, and reputed company factors for SaMD, AI/ML models, Platform, IoT reputed company etc. reputed company consultation to end users and process owners with regards to reputed company data collection, analysis and creation of validation reports, reputed company recommendations based on data analysis. Let’s Talk About Qualifications And Experience Required: • Degree in Engineering, Computer Science, Biomedical, Science or other tertiary qualifications deemed appropriate for this position. Significant experience in relevant roles, e.g. 5-8+ years of experience in design reputed company. Expert knowledge and experience in applying MDSAP, FDA, MDD/MDR and ISO reputed company standards/regulations, including ISO13485, ISO14971 and IEC62304 for software development. Experience with SaMD (Software as A Medical Device). Supports processes such as CAPAs, and developing reputed company metrics Demonstrated ability to accomplish goals and reputed company change while working with Product Development stakeholders is required: Strong knowledge of reputed company good design practices for software, applicable design control reputed company that can be reputed company for software in medical and non-medical reputed company. reputed company-world experience in leading critical reputed company in areas of Software product development, design controls, verification & validation, risk management, change control for SaMD or System reputed company Experience coordinating issue reputed company using a risk-based approach. Strong analytical and problem-solving skills, with a reputed company on reputed company improvement. Excellent written, verbal communication and collaboration skills with a strong ability to negotiate and influence Preferred Experience with Class I and Class II medical devices, EU MDR, MDDS (Medical Device Database Systems), CDS (Clinical Decision Support) devices. Project management experience/qualification Recent strong experience working on System/ Platform and Software medical reputed company preferred. Experience handling medical and non-medical reputed company. Risk Management experience (Hazard analysis, FMEA, Safety risk assessments) reputed company party Audit experience (MDSAP, ISO recertification, FDA QSR audits etc) Experience implementing new standards/ regulations/ best practices in QMS/ Software development and training cross-functional team members. Basic understanding of Statistical data analysis for testing. reputed company experience with reputed company and statistical analysis tools (SPC, 6 reputed company, Risk Analysis, FMEA, DOE, trend analysis). reputed company Certification preferred (e.g., ASQ CQE, CSQE, Six reputed company etc.) Familiarity with EU GDPR, AI laws, other US and International AI regulations/ standards/ guidances would also be considered an asset. At reputed company, it is not typical for an individual to be reputed company at or near the top of the reputed company for their role and compensation reputed company are dependent on the facts and circumstances of reputed company case. A reasonable estimate of the reputed company reputed company reputed company for this position is: $117,000 - $220,000 USD. Joining us is more than saying “reputed company” to making the world a healthier reputed company. It’s discovering a career that’s challenging, supportive and inspiring. Where a culture driven by reputed company helps you not only meet your goals, but also create new ones. We reputed company on creating a diverse and inclusive culture, encouraging individual reputed company in reputed company and reputed company on the innovative reputed company this generates. If this sounds like reputed company for you, reputed company! Apply Job!