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Quality Engineer II, Design Assurance Job

Expired Job

Boston Scientific Maple Grove , MN 55369

Posted 4 months ago

Date: Dec 1, 2018

Location:Maple Grove, MN, US, 55311

Company: Boston Scientific

Additional Locations:

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.

Key Responsibilities:

  • 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.

Qualifications:

  • 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

Preferred Qualifications:

  • 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).

  • 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: 437337

Nearest Major Market: Minneapolis

Job Segment: Quality Engineer, Medical, Engineer, Product Development, Engineering, Healthcare, Quality, Research


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VIEW JOBS 11/29/2018 12:00:00 AM 2019-02-27T00:00 Date: Jan 5, 2019 Location:Maple Grove, MN, US, 55311 Company: Boston Scientific Additional Locations: 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. Purpose Statement: 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. Key Responsibilities: * 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. Qualifications: * BS in Engineering with 2+ years of experience within Quality or related discipline. Or MS in Engineering with 0-2 years of experience * Must be willing to travel as required (10%) * Strong knowledge of risk management and design controls required. * Root cause investigation experience * Audit experience * Technical writing experience * Excellent written and verbal communication * Ability to prioritize effectively Preferred Qualifications: * Knowledge of Design Control, knows linkages between deliverables * Medical Device or regulated environment experience preferred * 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 * Able to influence decisions of others * Apply critical thinking skills and statistical analysis in monitoring complaints and field performance trends 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: 437664 Nearest Major Market: Minneapolis Job Segment: Quality Engineer, Medical, Engineer, Product Development, Engineering, Quality, Healthcare, Research Boston Scientific Maple Grove MN

Quality Engineer II, Design Assurance Job

Expired Job

Boston Scientific