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1+ months

Sr Design Quality Engineer

Boston, MA 02133
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Sr Design Quality Engineer


Boston, Massachusetts, United States

Requisition #:


Post Date:

Nov 06, 2020

**Careers that Change Lives**

You will join an advanced team of mechanical, electrical and software engineers responsible for developing Medtronics next generation products and newest technologies in the rapidly advancing Gynecological Womens Health market.

**_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 set 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.

Gynecological Womens Health group is committed to increasing patient access, improving affordability, and expanding less invasive options for women around the world. We will become the leader in GYN by collaborating with the healthcare community, partnering in surgeon and patient education, driving product innovation and standardizing care in MIS and less invasive therapies. _We aspire to become the most trusted womens health company globally_ .

**A day in the life**

A **Senior** **Design Quality Engineer** in the Woburn, MA office is expected to collaborate and communicate effectively with our cross functional teams and uphold Tenet 3 of the Medtronic mission: _To strive without reserve for the greatest possible reliability and quality in our products; to be the unsurpassed standard of comparison and to be recognized as a company of dedication, honesty, integrity, and service._

**_You Will:_**

Provide Quality Engineering support to ensure the successful development of Medtronic GYN products and ongoing operational support.Develops, modifies, applies and maintains quality standards and protocol for processing materials into partially finished or finished materials product.

Actively learn, and apply knowledge of Quality Systems, Design Controls, Risk Management, Statistics and Design for Reliability to positively influence development efforts, quality systems and processes, and ongoing contract manufacturing support as needed.

Ensure products are developed and manufactured in accordance with applicable industry standards, regulatory requirements, customer requirements, and product specifications.

Apply statistical techniques to determine sample size for testing, to analyze data, to determine process capability, to complete Measurement Systems Analyses, etc. (i.e. T-test, Tolerance Analysis, Bayes Success Run/Weibel analysis, Capability Analysis, Design of Experiments/ANOVA)

Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements.

An individual contributor with responsibility in our technical functions to advance existing technology or introduce new technology and therapies. Formulates, delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering RD, systems or initiatives related to new technologies or therapies from design to implementation - while adhering to policies, using specialized knowledge and skills.

**Differentiating Factors**


Seasoned individual contributor. Works independently under limited supervision to determine and develop approach to solutions. Coaches and reviews the work of lower level specialists; may manage projects / processes.

**Organizational Impact:**

May be responsible for entire projects or processes within job area. Contributes to the completion of work group objectives, through building relationships and consensus to reach agreements on assignments.

**Innovation and Complexity:**

Problems and issues faced are difficult, and may require understanding of multiple issues, job areas or specialties. Makes improvements of processes, systems or products to enhance performance of the job area. Analysis provided is in-depth in nature and often provides recommendations on process improvements.

**Communication and Influence:**

Communicates with senior internal and external customers and vendors.

Exchange information of facts, statuses, ideas and issues to achieve objective, and influence decision-making.

**Leadership and Talent Management:**

May provide guidance, coaching and training to other employees within job area. May manage projects, requiring delegation of work and review of others' work product.

**Required Knowledge and Experience:**

Requires advanced knowledge of job area combining breadth and depth, typically obtained through advanced education combined with experience.

**Must have:**

+ Bachelor of Science Degree in Biomedical, Mechanical, Electrical, Software, or other related fields

+ 4 years of experience in Medical Devices

**Nice to have:**

+ A Masters Degree in Biomedical, Mechanical, Electrical, Software, or other related engineering field and/or 2 years of experience in Medical Devices

+ Applied understanding of industry standards and regulations including, but not limited to: ISO 13485, 21CFR820, European Medical Device Directives (MDD), European Medical Device Regulations (MDR), ISO 14971, IEC 60601 series, IEC 62366-1, IEC 62304.

+ Experience with any of the following software suites: Matlab, Minitab, SAS

+ Experience applying Risk Management tools (Hazard Analysis, Risk Analysis, FMEAs, Fault Tree Analysis, Use Error Analysis, etc.)

+ Experience applying root cause analysis tools (Fishbone charts, 5 Whys, DMAIC, etc.)

+ Experience writing or guiding product requirements development*

+ Experience with gynecological medical devices

**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. Lets work together to address universal healthcare needs and improve patients lives. Help us shape the future.

Physical Job Requirements

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 to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America)
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.


Posted: 2020-11-10 Expires: 2021-03-21
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Sr Design Quality Engineer

Boston, MA 02133

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