Design Quality Engineer III - Endoscopy

At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we’ll help you in advancing your skills and career.

About The Role

This Design Quality Engineer III position is an opportunity to work for a worldwide and diverse company who puts patients first. Through this position, the ideal candidate develops, establishes and maintains quality engineering methodologies, systems, and practices which meet Boston Scientific (BSC), customer, and regulatory requirements. Partners closely with Research & Development, Regulatory Affairs, Manufacturing, and Post-Market Surveillance to ensure product quality, patient safety, and compliance through the application of Design Controls and Risk Management principles. The focus for this role will be quality engineering support for New Product Development and Sustaining activities, and Austin-site support for R&D lab and equipment operations.

This hybrid role is based in Austin, TX and requires being on-site at least three days per week. Relocation assistance may be available for this position. Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time.

Responsibilities

• Creative and resourceful problem-solving skills for moderate to complex mechanical and electrical devices.
• Ability to assist with troubleshooting, to the component level, moderate to complex mechanical assemblies.
• Working within a team of New Product Development and Sustaining Engineers.
• Actively contributing to all aspects of Design Quality Assurance activities in an FDA/EUMDR-Regulated Class II Medical Device environment.
• Support the design, development, and test of finished devices and accessories used in Boston Scientific Endoscopy product lines during their entire Development Life Cycle, from the Requirements gathering phase to the End-of-Life phase.
• Participate in product, system, and sub-system level design reviews with focus on device design evaluation, product risk mitigation, and other required Risk Management activities.
• Support the creation and execution of validation protocols to perform sub-system and system level testing of our products and report any issues discovered.
• Creation and review of risk management documentation such as Hazard Analysis, Task Analysis, Design Failure Mode and Effects Analysis (DFMEA) and Fault Tree Analysis (FTA).
• Creation and review of DQA documentation as required (e.g., Hazard Analysis, Design Failure Modes and Effects Analysis, Design Validation and Usability Engineering related documentation).
• Become a Subject Matter Expert (SME) for design controls and risk management requirements for the products supported.
• Contribute to Austin-site R&D laboratory and equipment programs by overseeing laboratory material controls and providing hands-on technical assistance with equipment qualification, calibration and preventive maintenance activities, including use of an electronic asset management system.
• Support all aspects of DQA activities during internal and external audits, as needed.
• Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
• May perform other duties as required.

Requirements

• BS in Biomedical, or Mechanical Engineering, or STEM degree.
• Minimum of 3 years of medical device engineering experience.
• Working knowledge of the FDA, ISO, EUMDR and the medical device industry quality requirements associated with product development, design controls, product risk management, usability engineering and medical device software.
• Detailed understanding and working knowledge of US and International regulations including 21 CFR part 820, is required, as well as the Medical Device Directive / Medical Device Regulation, EN ISO 13485 and EN ISO 14971.
• Practical knowledge of equipment calibration requirements and processes.
• Strong communication and presentation skills.
• Competent with use of Microsoft Office Suite, Minitab Statistical Analysis software (or equivalent).
• Ability to collaborate and work on a global team.
• Position located in Austin, Texas.
• Travel approximately 10-15% of the time.

Preferred Qualifications

• MS in Biomedical, or Mechanical Engineering preferred.
• 4+ years of medical device engineering experience preferred with 2+ years’ experience with medical device systems experience.
• Working familiarity with FDA QSR, EN ISO 13485, EN ISO 14971, and IEC 60601.

Pay

The anticipated compensation for this role ranges from $74,600 to $141,700. Compensation will be commensurate with demonstrable level of experience, pertinent education, and other relevant factors. Compensation for non-exempt (hourly), non-sales roles may also include variable compensation from time to time (e.g., overtime and shift differential) and annual bonus target. Compensation for exempt, non-sales roles may also include variable compensation, such as annual bonus target and long-term incentives.

Benefits

Core and optional employee benefits offered by Boston Scientific can be explored at www.bscbenefitsconnect.com.