1 Quality Engineer II - New Product Dev Job in Plymouth, MN
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Quality Engineer II - New Product Dev
$91k-109k (estimate)
Full Time | Medical Technology
2 Weeks Ago
Silk Road Medical is Hiring a Quality Engineer II - New Product Dev Near Plymouth, MN
Who We AreSilk Road Medical, Inc. is a medical device company located in Sunnyvale, California & Plymouth, MN, that is focused on reducing the risk of stroke and has pioneered a new approach for the treatment of carotid artery disease called TransCarotid Artery Revascularization (TCAR).
We are always looking for dynamic and innovative individuals who are passionate about reducing the risk of stroke. We welcome team members who approach their work with courage, flexibility, persistence, and a willingness to assist others with a strong emphasis on collaboration.
The opportunity This position will support new product development projects and execute design control deliverables as they are defined in the product development process to ensure high-quality designs and design efforts conform to the quality system.
This position works within high-performance cross-functional development teams to establish and maintain the design control deliverables, including but not limited to the creation of the risk management file, product and process requirements definition and verification, test method development and validation, and design validation to ensure delivery of the highest quality product to the customer.
This is a hybrid position.
A "Day in the life”
What We OfferOur philosophy is to make all benefits affordable to all Silk Road Medical employees and their dependents. We offer robust and affordable benefits with modest employee contributions. Click here for more information https://www.srmbenefits.com .
Our Commitment to Diversity, Equity & Inclusion We welcome all people who want to be part of our amazing journey and mission to provide new, innovative, and clinically proven transcarotid therapies to prevent the devastating burden of stroke. Our employees come from very different backgrounds: different races and ethnic backgrounds, different religions, and different parts of the world. Some of us are married to people of the opposite sex and some to the same sex, some are not married. Some of us are becoming parents for the first time and others are counting down the days to retirement. Some of us do cartwheels every day and some need physical accommodation to best perform their role. All are welcome.
We have a diverse workforce because we believe that it is possible for people with different backgrounds, viewpoints and persuasions to come together and debate important topics, learn from one another, and make better decisions than we would if we all were all the same. We want Silk Road Medical to not only be a great place to work, but The Greatest Place to Work and we strongly believe that a diverse and inclusive working environment is critically important to that goal.
Silk Road Medical is an equal opportunity employer and we value diversity at our company. We strictly prohibit unlawful discrimination based upon an individual's race, color, religion, gender, sexual orientation, gender identity, national origin/ancestry, age, disability, medical condition, marital status, veteran status, or any other characteristic protected by law.
We are always looking for dynamic and innovative individuals who are passionate about reducing the risk of stroke. We welcome team members who approach their work with courage, flexibility, persistence, and a willingness to assist others with a strong emphasis on collaboration.
The opportunity This position will support new product development projects and execute design control deliverables as they are defined in the product development process to ensure high-quality designs and design efforts conform to the quality system.
This position works within high-performance cross-functional development teams to establish and maintain the design control deliverables, including but not limited to the creation of the risk management file, product and process requirements definition and verification, test method development and validation, and design validation to ensure delivery of the highest quality product to the customer.
This is a hybrid position.
A "Day in the life”
- Executes on-time completion and supports development of Design Control deliverables such as Project Design & Development Plan, Design Verification, and Validation Plans.
- Partner with the design team in the development of program deliverables (Development Plan, Product Specification, Test Methods, Design Review, Design V&V, Usability Testing, Process Validation, and Labeling).
- With appropriate guidance, creates and maintains the content of risk management files following company procedures (i.e., hazard analysis, fault tree analysis, and FMEAs) with cross-functional partners.
- Create, execute, and maintain test method validation protocols and reports.
- Ensure Device History File (DHF) content completion, integrity, and regulatory & standards compliance by collaboratively identifying, communicating, and resolving gaps.
- Perform quality assurance, process controls, statistical analyses, and metrics of varied routines that ensure products meet or exceed internal quality and statutory requirements.
- Partner with Manufacturing & Operations to define, develop, establish, and implement quality requirements across the manufacturing processes, including equipment and process validation, test method validation, incoming, in-process, final product inspection, and process monitoring requirements.
- Support supplier quality engineering needs, including component qualifications, and participate in supplier audits when needed.
- Support internal and external regulatory audits.
- Provide quality and compliance input for product development and/or post-market product-sustaining activities, such as design changes.
- Participate in CAPA efforts, when assigned, and apply sound, systematic problem-solving methodologies by identifying, prioritizing, communicating, and driving resolution of quality issues (e.g., five why’s analysis, Is-Is Not analysis, and Six Sigma problem-solving methodologies).
- Identify and share potential improvements or enhancements to quality systems and processes in the company.
- Support implementation of corporate quality initiatives.
- Bachelor’s degree in a related field.
- 2 years of Quality Engineering or related experience; medical device experience strongly preferred.
- Champions 100% compliance with company policy and SOPs.
- Working knowledge of FDA, ISO, and the medical device industry quality requirements associated with product development, design controls, and product risk management.
- Effective communication and presentation skills.
- Competent with the use of Microsoft Office Suite and Minitab Statistical Analysis software (or equivalent).
- Travel up to 10%.
What We OfferOur philosophy is to make all benefits affordable to all Silk Road Medical employees and their dependents. We offer robust and affordable benefits with modest employee contributions. Click here for more information https://www.srmbenefits.com .
Our Commitment to Diversity, Equity & Inclusion We welcome all people who want to be part of our amazing journey and mission to provide new, innovative, and clinically proven transcarotid therapies to prevent the devastating burden of stroke. Our employees come from very different backgrounds: different races and ethnic backgrounds, different religions, and different parts of the world. Some of us are married to people of the opposite sex and some to the same sex, some are not married. Some of us are becoming parents for the first time and others are counting down the days to retirement. Some of us do cartwheels every day and some need physical accommodation to best perform their role. All are welcome.
We have a diverse workforce because we believe that it is possible for people with different backgrounds, viewpoints and persuasions to come together and debate important topics, learn from one another, and make better decisions than we would if we all were all the same. We want Silk Road Medical to not only be a great place to work, but The Greatest Place to Work and we strongly believe that a diverse and inclusive working environment is critically important to that goal.
Silk Road Medical is an equal opportunity employer and we value diversity at our company. We strictly prohibit unlawful discrimination based upon an individual's race, color, religion, gender, sexual orientation, gender identity, national origin/ancestry, age, disability, medical condition, marital status, veteran status, or any other characteristic protected by law.
Job Summary
JOB TYPE
Full Time
INDUSTRY
Medical Technology
SALARY
$91k-109k (estimate)
POST DATE
09/01/2024
EXPIRATION DATE
09/27/2024
WEBSITE
silkroadmed.com
HEADQUARTERS
CORVALLIS, OR
SIZE
200 - 500
FOUNDED
2007
TYPE
Public
CEO
WEN W CONNER
REVENUE
$50M - $200M
INDUSTRY
Medical Technology
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About Silk Road Medical
Silk Road develops, manufactures and distributes less-invasive devices for the treatment of carotid artery diseases.
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