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Integration Design Assurance Engineer II- Maple Grove Job

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Date: Jul 2, 2019

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 purpose—improving lives through your life’s work.


About the role:

The Integration Design Assurance Engineer II is a quality engineering position that directly supports the integration of an acquired medical device into the BSC quality system.  The individual will be responsible for execution of the transfer of design control deliverables, risk management activities, and DHF compliance.


Key responsibilities include:

•            Actively promote and participate in a cross-functional teamwork environment.

•            Executes the translation of product risk management tools (i.e. Hazard Analysis, Fault Tree, FMEAs).

•            Executes the translation of Design Controls based on Risk Management, Customer Needs, and Manufacturing Input.

•            Creates rationale for leveraging of Design Validation and Verification activities.

•            Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality/integration issues.

•            Demonstrate good working knowledge of regulatory requirements and internal standards.

•            Executes the transfer of the acquired product into BSC’s distribution network and post market surveillance process

•            Establish and maintain Design History File and Design Input / Output documentation (Product Specification, Component Specifications, and Prints).

•            Mentor cross functional team through product development process; specifically, with respect to design control and risk management deliverables


What we’re looking for:

Minimal qualifications:

•            BS in Engineering or related field of study and 2+ 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/or problem solving

•            Travel as required (20%)

•            Demonstrated use of Quality tools/methodologies

•            Able to influence decisions of others


Preferred qualifications:

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

•            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).

•            Previous experience with developing capital equipment as a medical device (if applicable)


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: 448308


Nearest Major Market: Minneapolis

Job Segment: Medical, Manufacturing Engineer, Engineer, Medical Technology, Risk Management, Healthcare, Engineering, Finance