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.

A Day in the Life

Sr Design Quality engineer for end-to-end product development (SW+Mechanical+Embedded)

This position is for design quality engineering support of Software, Mechanical, Firmware design and development of medical devices, stand-alone software, software medical devices, non-products, non-devices and components including mechanical and firmware. Facilitate the application of design controls in product development and released product management.

Responsibilities may include 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.
• Ensure that product development projects and changes to existing products are conducted in compliance with ISO 13485, IEC 62304, ISO 14971, IEC 60601, 21 CFR part 820, 21 CFR part 11, 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, preliminary hazard analysis, software hazard analysis, product hazard analysis, DFMEA, SFMEA, UFMEA and risk management report).
• Review & participate in Cybersecurity assessments
• Partner with Software, Mechanical & Embedded engineering teams to assess risk, develop software design plans and documentation, ensure code, drawings, design and integration reviews occur, and to demonstrate product 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.
• Hanson experience in SW anomaly evaluation and disposition, complaint investigation, NC/CAPA
• Ensure successful transfer of new products to production facility by assisting in 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 mechanical drawings, PCB layouts, mechanical/system testing and firmware testing; Human factors/usability assessment, Radio frequency testing, Sterilization testing, Biocompatibility testing, shelf-life testing, labelling & packaging.
• End to end product development deliverables review (software, mechanical, firmware)
• Review Design History Files and Technical Files for conformance to applicable requirements.
• Participate when appropriate in audits
• Demonstrates mastery of software development and testing methodologies
• Ensures applicability to SOUP / OTS validations in the product development
• Participates on CCB to decide upon CR implementation.
• Participate and provide input to training on department / procedures and policies
• Hands-on experience on Risk Management, Design Controls. 
• Acts as the subject matter expert on risk management for one or more products/platforms.
• 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 product 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.
• Provide Quality support to facilitate resolution of product complaints and/or safety issues
• Provide support to the Regulatory Department in writing technical submissions.
• Good verbal and written communication skills including protocol / report development and technical presentations.
• Familiar with statistical software tools (Minitab, Stat Graphics)

Required Knowledge and Experience

• B E or B.Tech
• Minimum 6-8 years of quality engineering experience or equivalence and overall 8-13 years of experience

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. 

Benefits & Compensation

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.
 

About Medtronic

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.

Learn more about our business, mission, and our commitment to diversity here