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Principal Software Design Quality Engineer - Ventilation


Carlsbad, CA
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Job Details

Company Medtronic
Job Title Principal Software Design Quality Engineer - Ventilation
JobId 25091
Location: Carlsbad, CA, 92008, USA

Principal Software Design Quality Engineer - Ventilation


Carlsbad, California, United States

Requisition #:


Post Date:

Oct 24, 2017

**Principal Software Design Quality Engineer - Ventilation**

The **Principal Software Design Quality Assurance Engineer** will participate in the execution of new product development and sustaining products administration of quality assurance programs, policies, processes, procedures and controls in compliance with internal and external requirements. The individual will act as a subject matter expert and provide guidance to the business in interpreting and executing against Medtronic quality system elements including software work products to ensure compliance. This individual will ensure that all system-level project / program work products (e.g., plans, requirements, specifications, tests, test results, traceability, risk management documents, reports) meet Medtronic’s quality, reliability, and compliance requirements.

**Essential Functions:**

• Review all project / program software work products (e.g. plans, requirements, specifications, tests, test results, traceability, risk management documents, reports).

• Collaborate with project / program teams to ensure work products comply with Medtronic procedures, acceptable qualitative and quantitative criteria, and global standards, regulations, and guidance.

• Plans, develops and implements validation plans for new product development in conjunction with RD, Process Engineering, Manufacturing, Supplier Quality Assurance, Regulatory Affairs, Marketing and other service groups.

• Generates documentation at the project level, including software and system risk assessment (risk analysis), and requirements compliance matrix (ERM).

• Assist in the analysis of field returns and in-process non-conformities.

• Perform CAPA projects and activities.

• Participate in technical design reviews (Software), Project phase reviews; CCB (Change Control Board) reviews, post market trend reviews

• Apply and improve advanced technical principles, theories, and concepts in the monitoring and coordination of various design, development, testing, and quality activities.

• Utilize knowledge of embedded systems and application software.

• Utilize knowledge of various Software Development Life cycle (SDLC) models (e.g. waterfall, spiral / iterative, scrum)

• Utilize knowledge of risk management (generation of software and system risk analysis), CAPA, and/or Design Controls.

• Working knowledge of IEC 62304, FDA’s General Principles of Software validation, ISO 13485, ISO 14971, 21 CFR 820, IEC 60601-1 and MDD

• Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criterion for obtaining solutions.

• Ensure that product development projects and changes to existing products are conducted in compliance with the FDA Quality System Regulations Design phases.

• Participate on cross-functional teams to review marketing requirements and to develop concise, unambiguous, non-conflicting and feasible product requirements that support the market needs.

• Lead and/or participate on cross-functional teams to develop product risk management file (risk management plan, risk assessments, DFMEA, SWFMEA, FTA, and risk management report).

• Create and/or assist in the creation of verification and validation test plans. Oversee testing and analysis for standards and product requirements compliance.

• Provide guidance and direction for sample size and statistical analysis of verification and validation test results.

• Review Design History Files and Technical Files for conformance to applicable requirements.

• Assist, when appropriate with internal and supplier audits.

• Provide Quality support to facilitate the rapid resolution of product complaints and/or safety issues.

• Adheres to the competencies and skills for the specified position as defined in the Quality Professional Leveling Matrix.

• Other duties as assigned with or without accommodation.

**Required Qualifications:**

•Bachelor of Science degree in Software Engineering, Computer Science, Computer Engineering or Electrical Engineering

•10+ years’ experience with software quality assurance

•8+ years’ experience in the medical device industry

•Strong familiarity with regulatory requirements ISO 13485,CFR 820 EN ISO 14971, IEC 62304.

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

•Risk Management, ISO 14971, FTA, FMEA, HACCP.

•Comparative Statistical techniques, sampling plans, GRR, K-factor, hypothesis testing and ANOVA.

•Test plan development and root cause failure analysis.

**Preferred Qualifications:**

•Master's degree in Software Engineering, Computer Science, Computer Engineering or Electrical Engineering

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

•ASQ CQE, CQA, CSQE and/or CRE certification.

•Familiar with statistical software tools (Minitab, Stat Graphics, Statistic),

•Stability, Biocompatibility, Sterilization, Ship Testing, HALT/HASS.

•Familiar with IEC 60601 and product specific industry standards.

•Familiar with DMAIC or DMADV(DFSS) methodologies

•DFSS / Lean Green Belt or Black Belt

**Physical Job Requirements:**

Normal Office and lab Conditions. Must be able to operate a computer and a telephone. Some minimal amount (15%) of travel by plane and car may be required.

The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities.

**About Medtronic:**

Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.

We can accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let’s work together to address universal healthcare needs and improve patients’ lives. Help us shape the future.

**EEO Statement:**

It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.

This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here:


The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.

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