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Sr. Design Quality Engineer

Boston, MA
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  • Job Code
Company Medtronic
Job Title Sr. Design Quality Engineer
JobId 35015
Location: Boston, MA, 02133, USA

Sr. Design Quality Engineer


Boston, Massachusetts, United States

Requisition #:


Post Date:

Oct 11, 2017

Careers that Change Lives

You will be a key member of the Medtronic Quality Engineering team working to commercialize a Surgical Robotics Platform.

Your will join the product development team as the quality representative on a cross-functional team responsible for risk analysis (fault tree analysis and FMEA/FMECA), oversight of design subsystem verification, component specification and approval, process evaluation and nonconforming product analysis.

Impact patient outcomes. Come for a job, stay for a career.

The Minimally Invasive Therapies Group strives to enable earlier diagnosis, better treatment, faster complication-free recovery, and enhanced patient outcomes through less invasive surgical solutions.

SURGICAL INNOVATIONS sets the standard for Minimally Invasive Surgery (MIS) by creating innovative surgical products and services that focus on obesity and diseases and conditions of the gastrointestinal tract, lung, abdominal wall, pelvic region, and the head and neck.

A Day in the Life

This position can be located in Boston, MA or North Haven, CT and you will be involved in:

• Overall responsibility for ensuring the adequacy of design quality for the Surgeon User Interface subsystem for the Minimally Invasive Surgical System, including documentation and other supporting quality evidence.

• Facilitating and managing Design and Process FMEAs/FMECAs in a research and development setting for the Surgeon User Interface and potentially other subsystems within the Minimally Invasive Surgical System.

• Providing guidance and oversight of the plans and methods for subsystem verification.

• Providing guidance on the principles of electrical engineering and IEC standards as they relate to the new product development activities of electromechanical medical devices.

• Providing oversight and approval for Reliability Plans and ensure that they are properly executed throughout the development and qualification processes.

• Participating in engineering Design Reviews

• Participating in Defect / Issue Management and Change Control Boards, as appropriate.

• Managing the Risk Management Process per ISO 14971 at a subsystem level.

• Qualifying production components through Covidien’s Production Part Approval Process (PPAP).

• Developing Quality inspection procedures, including sampling plans, for both production level components and finished devices.

• Initiating corrective action requests on non-conformances (internal or external) and verifying the effectiveness of corrective actions.

• Contributing to the development of Process Flows, Control Plans, Design of Experiments, Measurement Systems Analyses, and Process Capability Analyses.

• Ensuring all FDA and ISO validation requirements are met and for the review and approval of all validation protocols (IQ, OQ, PQ and MSA).

• Ensure internal Design Control policies and procedures comply with regulations and external standards, including software regulations, risk management, and change control.

• Contribute to the streamlining and continuous improvement of the product development process to ensure robust and efficient development and launch of new and innovative products.

• Provide guidance for the application of internal development procedures, including Design Control, to the product development teams, within the framework of regulatory requirements..

• Interact and form constructive working relationships with all levels of leadership within Quality, Procurement, Marketing, RD, and Operations

Must Have: Minimum Qualifications

You must hold a minimum of a Bachelor’s degree in Mechanical or Bio-Medical Engineering, Math, Physical Science, or other related field with 5+ years of experience of developing complex electro-mechanical and/or robotic systems in a regulated industry.

• Experience in the facilitation of effective DMEAs/DFMECAs for complex electromechanical systems.

• Knowledge of Standards Applicable to Medical Device Safety/Risk Management (ISO 13485, ISO 14971, ISO 62303, IEC 60601-1, US 21 CFR Part 820, and related standards)

• Experienced in the practical application of Systems Engineering and Systems Verification principles

• Knowledge of Design Control Systems and ability to apply project management techniques

• Experience with supplier management and component qualification practices

• Experience managing a comprehensive risk management process for complex medical devices

• Working knowledge of quality engineering principles, supplier management, and manufacturing operations within a regulated industry (preferably medical devices).

• Proficient with utilization of quality tools (Six Sigma, Statistical Techniques, Sampling Principles, Risk Assessment, Root Cause Analysis, FMEA, FTA, DOE, etc.).

• Experience with Minitab or similar statistical analysis tools

• Experience with Geometric Dimensional and Tolerancing (GDT)

• Fundamental understanding of electronic and electromechanical designs and manufacturing processes to support designing, troubleshooting, refining and qualifying the design to ensure the sustainable manufacturing of medical devices both internal and external

Nice to Have

• Master’s Degree in Engineering, Computer Science, or Business Administration (MBA)

• Experience with new product development in the medical device industry.

• Green or Black Belt Six Sigma Certification (DFSS or DMAIC)


• Standard office setting, surgical lab, operating room, pilot lab, external research organizations, supplier visits

• Distributed RD teams

• Some travel may be required, mostly to Boston, MA

About Medtronic

Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services 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 want to 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.

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.

The physical demands described within the Day in the Life 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 to perform the essential functions.


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:


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Boston, MA

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