Sr Design Quality Engineer

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You'll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.

Software Design Quality engineer to support CST ET products.

Responsibilities may include the following and other duties may be assigned

• Review New Product Introduction (NPI) and Released Product Management (Released Products) documentation for quality characteristics, including manufacturability, serviceability, testability, reliability, and product requirements.
• Hands on experience with tools package release process for both Software & Hardware tools/accessories
• Review non product/off-the shelf tools for products
• Experience in software or hardware design transfer process for tools or products
• Familiar with ISO 13485, IEC 62304, ISO 14971, IEC 60601, 21 CFR part 820, 21 CFR part 11, EUMDR and product specific industry standards.
• Ensure that product development projects and changes to existing products are conducted in compliance with IEC 62304, FDA Quality System Regulations, EU MDR and inhouse Standards.
• Participate on cross-functional teams to develop product risk management file (risk management plan, risk assessments, DFMEA, and risk management report).
• Assist in the creation or review of verification and validation plans, protocol and reports. Oversee testing and analysis for standards and product requirements compliance.
• Hanson experience in SW anomaly evaluation and disposition, complaint investigation, NC/CAPA
• Ensure successful transfer of new products/tools to production facility by assisting in development of process validation requirements (PFMEA, IQ, OQ, PQ) using appropriate statistical tools and techniques.
• Review Design History Files and Technical Files for conformance to applicable requirements.
• Participate when appropriate in audits
• Ensures applicability to SOUP / OTS validations in the product development
• Participate and provide input to training on department / procedures and policies
• Hands-on experience on Software Risk Management, Design Controls.
• 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.
• Previous experience working in a cross-functional team environment.
• 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 in Software/Electrical engineering

• Minimum 6-8 years of quality engineering experience or equivalence and overall 8-12 years of experience

• Previous experience working in a cross-functional team environment.

• Familiar with statistical software tools (Minitab, Stat Graphics)
• Working knowledge of and auditing experience to the FDA Quality System Regulation, ISO 13485, and the Medical Device Directive.
• 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 Requirements

The 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.

Medtronic 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.

This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).

We 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 95,000+ 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.