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Engineer II, Design Assurance Job

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Date: May 22, 2019

Location: Maple Grove, MN, US, 55311

Company: Boston Scientific

Additional Locations: (n/a)

 

 

Purpose and Passion • Comprehensive Benefits • Life-Work Integration • Community • Career Growth

At Boston Scientific, you will find a collaborative culture driven by a passion for innovation that keeps us connected on the most essential level. With determination, imagination and a deep caring for human life, we’re solving some of the most important healthcare industry challenges. Together, we’re one global team committed to making a difference in people’s lives around the world. This is a place where you can find a career with meaningful purpose—improving lives through your life’s work.

 

The Design Assurance Engineer II is a quality engineering position that directly supports the product development cycle for innovative medical devices; responsible for execution of design control deliverables, risk management activities, and DHF compliance.  Develops, establishes and maintains quality engineering methodologies, systems, and practices which meet BSC, customer, and regulatory requirements. Provides focused quality engineering support within commercial execution to ensure the delivery of the highest quality product to the customer.

Key Responsibilities:

•Work within a product ownership team to identify and implement effective controls to support changes, qualification, and continued commercialization of products to meet or exceed internal and external requirements.

•Lead in the testing and validation of design changes to meet or exceed internal and external requirements.

•Act as an effective leader or team member in supporting quality disciplines, decisions, and practices.

•Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues utilizing CAPA systems.

•Assure in the development and execution of streamlined business systems which effectively identify and resolve quality issues.

 Qualifications:

•BS in Engineering or related field of study2+ years of experience within Quality or related discipline or MS in Engineering with 0-2 years of experience

•Working knowledge of risk management and design controls including connection between tools from Risk Management planning through impact to process controls

•Excellent written and verbal communication

•Effectively prioritize and adapt to shifting priorities

•Work collaboratively in a project team environment

•Previous experience with leadership, mentoring, project management and problem solving

•Travel as required (10%)

•Root cause investigation

•Technical writing experience

•Demonstrated use of Quality tools/methodologies.

•Able to influence decisions of others

Preferred Qualifications:

•Big picture view, but also able to execute individually on specific deliverables such as product design verifications/validation, failure analysis

•Problem solver with the knowledge of problem solving tools, capable of facilitating problem solving process

•Apply critical thinking skills and statistical analysis in monitoring complaints and field performance trends

•Medical Device or regulated environment experience

•Strong understanding of design control and risk management (Design Control 21CFR820.30, Risk Management per ISO14971, Quality System ISO 13485).

•Audit experience

 Quality System Requirements:

•In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.

•Assures that appropriate resources (personnel, tools, etc.) are maintained to assure Quality System compliance and adherence to the BSC Quality Policy.

•Establishes and promotes a work environment that supports the Quality Policy and Quality System. This is a quality engineering position that directly supports the product development cycle for innovative medical devices; responsible for execution of design control deliverables, risk management activities and DHF compliance.

 

About us

As a global medical technology leader for more than 35 years, our mission at Boston Scientific (NYSE: BSX) is to transform lives through innovative medical solutions that improve the health of patients. If you’re looking to truly make a difference to people both around the world and around the corner, there’s no better place to make it happen.

 

Boston Scientific is an Equal Opportunity Employer – Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Disability, Veteran

 

Requisition ID: 446605

 


Nearest Major Market: Minneapolis

Job Segment: Medical, Engineer, Design Engineer, Product Development, Medical Technology, Healthcare, Engineering, Research