Senior Software Quality Engineer - Global Device Software Steward Support

About the role

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.

Responsibilities

• Best Culture: 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.
• Best Agility: 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.
• Best Performance: 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. Initiative 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.
• Best Compliance: 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.

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).
• 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)

Qualifications

• 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)

Skills

• 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)

Benefits

The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) – see www.bscbenefitsconnect.com—will vary based on actual location of the position and other pertinent factors considered in determining actual compensation for the role. Compensation will be commensurate with demonstrable level of experience and training, pertinent education including licensure and certifications, among other relevant business or organizational needs.

Pay

Minimum Salary: $ 85000 Maximum Salary: $ 161500

Schedule

The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) – see www.bscbenefitsconnect.com—will vary based on actual location of the position and other pertinent factors considered in determining actual compensation for the role. Compensation will be commensurate with demonstrable level of experience and training, pertinent education including licensure and certifications, among other relevant business or organizational needs.