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

A Day in the Life

• 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.

Must Have

• Review New Product Introduction (NPI) and Released Product Management (Released Products) documentation for quality characteristics, including manufacturability, serviceability, testability, reliability, and product requirements.
• 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).
• 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.
• 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 Design History Files and Technical Files for conformance to applicable requirements.
• Participate when appropriate in audits
• Demonstrates mastery of software development and testing methodologies
• Independently develops test strategies for new, pre-concept features in development.
• Ensures applicability to SOUP / OTS validations in the product development
• Participates on CCB to decide upon CR implementation.
• Assesses the compliance of the software development methodology to the approved process.
• Participate and provide input to training on department / procedures and policies
• Hands-on experience on Software Risk Management, Design Controls.
• Facilitates hazard analysis and SFMEA sessions. Prepares the risk management file.
• 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 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.
• Provide Quality support to facilitate resolution of product complaints and/or safety issues
• Provide support to the Regulatory Department in writing technical submissions.

Minimum Qualification

• B E or B.Tech
• Minimum 6-8 years of quality engineering experience or equivalence and overall 8-12 years of experience

Key Technical Competencies

• 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.
• Good verbal and written communication skills including protocol / report development and technical 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

Nice to Haves

• ASQ CQE, CQA, CSQE and/or CRE certification.
• ISO 13485 Internal Auditor / Lead Auditor Certification
• Lean Six Sigma Green Belt or Black Belt
• Comparative Statistical techniques, sampling plans, GRR, K-factor, hypothesis testing, ANOVA, parametric and non-parametric analysis.
• Familiar with DMAIC or DMADV(DFSS) methodologies

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.

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 90,000+ passionate people.
We are engineers at heart putting ambitious ideas to work to generate real solutions for real people. From the RD 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