Date: Dec 1, 2018
Location:Maple Grove, MN, US, 55311
Company: Boston Scientific
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 purposeimproving 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 new product development and sustaining to ensure the delivery of the highest quality product to the customer.
Works within a development team to identify and implement effective controls to support the development, qualification, and commercialization of products to meet or exceed internal and external requirements.
Lead in the testing and validation of new designs to meet or exceed internal and external requirements.
Acts 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.
Assure in the development and execution of streamlined business systems which effectively identify and resolve quality issues.
BS in Engineering or related field of study with 2+ years of experience within Quality or related discipline or MS in Engineering with 0-2 years of experience.
Previous experience with leadership, mentoring, project management and problem solving.
Must be willing to travel as required (10%)
Working knowledge of risk management and design controls.
Root cause investigation
Technical writing experience
Demonstrated use of Quality tools/methodologies.
Excellent written and verbal communication
Ability to prioritize effectively
Works effectively in a project team environment
Able to influence decisions of others
Electrical Systems experience (development and sustaining)
Able to see the big picture, but also able to execute 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
Electrical Systems experience with knowledge of IEC 60601-1, 60601-1-2, and 62304.
Strong understanding of design control and risk management (Design Control 21CFR820.30, Risk Management per ISO14971, Quality System ISO 13485).
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.
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: 437337
Nearest Major Market: Minneapolis
Job Segment: Quality Engineer, Medical, Engineer, Product Development, Engineering, Healthcare, Quality, Research