Senior Software Quality Engineer - Global Device Software Steward Support

Boston Scientific•Arden Hills, MN

8d•$85,000 - $161,500•Hybrid

About The Position

This Device Software Sub-Process Steward Support role teams with the Device Software Sub-Process Steward to help with leadership and oversight to the Device Software sub-process. The Device Software sub-process controls device software considered a finished medical device or used as a component, part, or accessory of a medical device developed, subcontracted, modified, or purchased. Quality System Stewards use the Best4 (Culture, Agility, Performance, Compliance) Strategy to enable our Quality Policy. Global Quality System Device Software sub-process maintain oversight of all processes in their assigned Sub-Process. Sub-Process Stewards work together to maintain their assigned Process(es) and ensure all responsibilities are fulfilled.

Requirements

Bachelor’s level degree in Science/Engineering/Computer Science/Software Engineering discipline and/or Minimum of 4 years of related experience in the Medical Device regulated industry.
Working knowledge of regional and international quality system requirements including 21 CFR 820, ISO 13485, IEC 62304; ISO 14971; FDA Guidance – General Principles of Software Validation and Computer Software Assurance for Production and Quality System Software.
Must have good understanding of quality system requirements and how each quality system element connects.
Comfortable speaking and presenting to leadership
Strong written and verbal communication skills in English
Experience managing projects and project deliverables to completion
Comfortable working independently and as part of a cross-functional team
Ability to manage multiple priorities
Proficient in Microsoft Office
Works willingly and effectively with others in and across the organization to accomplish team goals with excellent interpersonal and networking skills.
Values people’s opinions and encourages knowledge sharing. High level of energy, drive and enthusiasm
Knowledge of Software Engineering Principles and Software Development Life Cycle (SDLC)
Ability to work independently and collaborate with cross-functional teams to complete projects
Strong critical thinking and analytical skills: process and results-oriented
Detail oriented with strong organizational skills; ability to multi-task and prioritize competing responsibilities effectively

Nice To Haves

Device Software Engineering Experience, including: Device Software Development, Device Software Testing / Verification, Risk Management, Cybersecurity, Artificial Intelligence / Machine Learning, Agile Practices
Experience in supporting and enhancing the QMS processes including: Device Software Development, Design Controls, Risk Management, Post Market and Premarket Cybersecurity
Experience working with Medical Device Software Advocacy, Standards and Professional Organizations (i.e. AAMI; MDIC; IEC; FDA; AdvaMed; NIST; IMDRF)
Formal Project Management Experience
CAPA, Vendor Controls, Complaint Handling and Internal/External Audits Experience
Software Development Tools Experience (i.e. Jira; Cockpit; Github; Codenvy; Bitbucket)

Responsibilities

Sustain Device Software Community of Practice (CoP).
Provide subject matter expertise for the organization and collaborate with site/divisional experts.
Write applicable annual quality goals and objectives with input from sites, divisions, regions, and leadership to align with Best4 and organizational strategies. Support and update goals and objectives throughout the year.
Monitor Device Software Sub-Process and implement process improvements based on performance feedback.
Drive value improvement projects (VIP) to support organizational goals.
Support acquisition integration as needed.
Increase Quality System simplicity, efficiency and predictability with standardization and lean practices.
Maintain and enhances internal and external relationships in support of the Global Quality System Process/Sub-Process.
Monitor and mitigate Quality System Process compliance risk where appropriate.
Lead or oversee quality projects of major magnitude and scope. Provide input to overall quality project portfolio and project priorities.
Determine if changes are reportable to notified bodies.
Initiate corporate preventive CAPAs and own or participate in corporate preventive CAPA teams.
Create, implement, and sustain measures and metrics to monitor Device Software Sub-Process health.
Provide metrics, data and analysis for management review.
Establish and maintain Global Quality System Device Software Sub-Process to ensure compliance with applicable quality and regulatory requirements.
Review of new Laws Regulations Standards and Guidance’s (LRGS) and the implementation of new requirements into the BSC Quality System.
Communicate new and updated requirements.
Provide subject matter expertise and support for corporate and site internal and external audits.
Review quarterly data per Quality System Process Compliance Assessment.
Support the audit non-conformance response strategies.
Identify Global Quality System Device Software Sub-Process training requirements.
Support corporate NCEP & CAPA Processes.
Assess reportability of substantial Quality System Changes.
Ensuring quality records are created, maintained and dispositioned.