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Senior Design Assurance Safety Engineer-Arden Hills Job

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Date: Jul 21, 2019

Location: Arden Hills, MN, US, 55112

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:

Provide safety risk management analysis of product performance throughout product lifecycle. Provide reliability quality engineering support to product development teams, helping to ensure development of highest quality new products. Identify, anticipate, and escalate quality concerns early in product lifecycle.


Your responsibilities include:

• Develops and implements product Risk Management Plans, Reports, and Hazard Analysis for product risk management file.

• Collaborates with R&D engineering, Manufacturing, Supplier Quality, and Medical Safety leadership to characterize and document product risk control measures within design documentation.

• Utilizes product development tools (Fault tree Analysis (FTA), Failure Modes Effect Analysis (FMEA), Hazard Analysis (HA), etc.) to characterize, document, and predict probability of occurrence of hazards and harms associated with product commercialization lifecycle.

• Leads Product/Process improvement efforts by identifying methods to capture quality metric data and identifying & performing appropriate analysis methods to enhance sustaining product design and new product development.

• Supports sustaining engineering projects teams on assessing product changes and product performance risk analysis.

• Supports Post Market Quality Assurance teams with post product commercialization to identify increased or new failure rates associated with fielded product.

• Supports regulatory requests associated with product submission and recertification activity not limited to clinical evaluation summaries, and CA Post Market Additional Information Requests as a technical safety engineering Subject Matter Expert (SME).


What we're looking for:

Minimal qualifications:

• Bachelor's degree in a technical field

• 5+ years quality engineering industry experience

• Experience maintaining compliance to ISO 14971, ISO 60601-1 standards

• Strong interpersonal, organizational, and project management skills

• Demonstrated communication skills, both verbal and written

• Ability to work in a team- based environment

• Ability to influence teams with data and analysis


Preferred qualifications:

• Master’s Degree in technical related field (Electrical, Mechanical, Systems) and CRE ASQ certifications

• Knowledge or experience working with Single Use Device (SUD) BSC or other medical device manufacturer products

• Medical Device or regulated industry experience

• Supplier Controls process knowledge and experience



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: 447974


Nearest Major Market: Minneapolis

Job Segment: Medical, Safety Engineer, Manufacturing Engineer, Engineer, Electrical, Healthcare, Engineering