Job Description

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. Youll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.A Day in the Life Principal Design Quality Engineer-SoftwareProvide design quality engineering support in design and development of medical device products. Facilitate the application of design controls in product development and sustaining changes.

• Review new and modified product design documentation for quality characteristics, including manufacturability, serviceability, testability, reliability, and product requirements.
• Capable of mentoring junior quality engineers in providing quality engineering support for their medical device products.

Responsibilities may include the following and other duties may be assigned

• Drive end to end product & process design quality for Software projects
• Guide & support team for FDA or EUMDR submissions
• Review new and modified product design documentation for quality characteristics, including manufacturability, serviceability, testability, reliability, and product requirements
• Ensure that product development projects and changes to existing products are conducted in compliance with FDA Quality System Regulations, EU MDR and inhouse Standards
• Participate in design reviews and provide input on design verification and validation activities.
• Participate on cross-functional teams to develop product risk management file (risk management plan, risk assessments, DFMEA, and risk management report).
• Partner with Software Engineering to assess risk, develop software design plans and documentation, ensure code and integration reviews occur, and to demonstrate software capability and maturity.
• Assist in the creation of verification and validation plans, protocol and reports. Oversee testing and analysis for standards and product requirements compliance.
• Ensure successful transfer of new products to production facility by assisting in the development of process validation requirements (PFMEA, IQ, OQ, PQ) using appropriate statistical tools and techniques.
• Strong in software design and development, software verification and validation activities
• Review Design History Files and Technical Files for conformance to applicable requirements.
• Stay updated with changes in regulatory standards and implement necessary updates to processes and documentation.
• Experience with Agile and DevOps methodologies.
• Familiarity with cybersecurity standards for medical devices.
• Good exposure to ISO 27001 standard
• Hands on experience on implementing security controls
• Lead and mentor the design quality engineering team
• Take ownership of software audits
• Demonstrates mastery of software development and testing methodologies
• Independently develops test strategies for new, pre-concept features in development.
• Provides guidance to associate and level 1 quality engineers.
• Assesses the compliance of the software development methodology to the approved process.
• Participate and provide input to training on department / division procedures and policies
• Facilitates hazard analysis and SFMEA sessions. Updates the risk management file.
• Acts as the subject matter expert on risk management for one or more products/platforms.
• Ensures applicability to SOUP / OTS validations in the product development
• Participates on CCB to decide upon CR implementation.
• Applies quality system regulations, applicable standards and guidance to multiple projects
• Develop templates and training based on the quality system regulations, applicable standards and guidance.
• Independently reviews all SW deliverables to ensure compliance with development process and the standard.
• Deliver presentations to the QA organization on status and issues of assigned projects.

Deliver training to departments outside of QA. * Demonstrates ability to effectively play multiple roles on a cross-functional team including contributor, subject matter expert, leader, facilitator.

• Previous experience working in a cross-functional team environment.
• Hands-on experience on Risk Management, Design Controls.
• Provide Quality support to facilitate resolution of product complaints and/or safety issues
• Provide support to the Regulatory Department in writing technical submissions.

Required Knowledge and Experience

• B E or B.Tech
• Minimum 8-12 years of quality engineering experience or equivalence and overall 14+ years of experience

Key Technical Competencies

• Previous experience working in a cross-functional team environment.
• Familiar with statistical software tools (Minitab, Stat Graphics)
• Familiar with ISO 9001, ISO 13485, IEC 62304, ISO 14971, IEC 60601, 21 CFR part 820, 21 CFR part 11, EUMDR, ISO 27001 and product specific industry standards.
• Working knowledge of and auditing experience to the FDA Quality System Regulation, ISO 13485, and the Medical Device Directive.
• Good verbal and written communication skills including protocol / report development andtechnical presentations.
• Strong in software design and development, software verification and validation activities
• Computer literate and experience with PCs, networks, applications, software development life cycle
• Travel may be required
• Knowledge in cybersecurity

Physical Job RequirementsThe above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.Benefits & CompensationMedtronic offers a competitive Salary and flexible Benefits Package
A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.About MedtronicWe lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission to alleviate pain, restore health, and extend life unites a global team of 90,000+ passionate people.
We are engineers at heart putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.Learn more about our business, mission, and our commitment to diversity

Medtronic