Principal AI Technical Lead at Boston Scientific Corporation Malaysia

Arden Hills, Minnesota, United States -

Full Time

Start Date

Immediate

Expiry Date

08 Mar, 26

Salary

188300.0

Posted On

08 Dec, 25

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

AI/ML Algorithms, Validation, Performance Monitoring, Regulated Environments, Cybersecurity, Risk Assessment, Mitigation Strategies, GMLP, FDA Guidelines, EU MDR Requirements, Data Governance Practices, CADe Development, CADx Development, Product Lifecycle Management, Regulatory Engagement, Cross-Functional Collaboration

Industry

Medical Equipment Manufacturing

Description

Bachelor's or Master's degree in Computer Science, Biomedical Engineering, or a related field. Minimum of 10 years' experience designing, developing and productizing AI-based SaMD systems. Proven track record of managing the full product lifecycle for AI SaMD under FDA and EU regulatory frameworks. Hands-on experience with CADe and CADx development and submissions to U.S. FDA and EU notified bodies. Deep understanding of GMLP, FDA guidelines and EU MDR requirements for AI SaMD. Familiarity with IMDRF SaMD framework or other SaMD product development life cycle processes. Knowledge of key data governance practices in AI SaMD development. Strong expertise in AI/ML algorithms, validation, and performance monitoring in regulated environments. Experience in cybersecurity for AI medical devices, including risk assessment and mitigation strategies. PhD in Computer Science, Biomedical Engineering, or related field. Proven leadership ability with cross-functional collaboration and regulatory engagement experience. - IEC 62304 (Software Life Cycle) - ISO 13485 (Quality Systems) - IEC 14971 (Risk Management) - IEC 27001 (Information Security) - HIPAA/PHI data handling protocols Requisition ID: 619526 Minimum Salary: $ 99100 Maximum Salary: $ 188300 Compensation will be commensurate with demonstrable level of experience and training, pertinent education including licensure and certifications, among other relevant business or organizational needs. At BSC, it is not typical for an individual to be hired near the bottom or top of the anticipated salary range listed above. Compensation for non-exempt (hourly), non-sales roles may also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements). Compensation for exempt, non-sales roles may also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements). For MA positions: It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability. As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most - united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate. Now more than ever, we have a responsibility to apply those values to everything we do - as a global business and as a global corporate citizen. And if you're a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you! That is why we stand for inclusion, equality, and opportunity for all. By embracing the richness of our unique backgrounds and perspectives, we create a better, more rewarding place for our employees to work and reflect the patients, customers, and communities we serve. To ensure full implementation of its equal employment policy, the Company will continue to take steps to assure that recruitment, hiring, assignment, promotion, compensation, and all other personnel decisions are made and administered without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, gender expression, veteran status, age, mental or physical disability, genetic information or any other protected class. Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company's policies or protocols change with regard to COVID-19 vaccination. This role is deemed safety-sensitive and, as such, candidates will be subject to a prohibited substance test as a requirement. The goal of the prohibited substance testing is to increase workplace safety in compliance with the applicable law.

Responsibilities

The Principal AI Technical Lead will be responsible for designing, developing, and productizing AI-based SaMD systems while managing the full product lifecycle under FDA and EU regulatory frameworks. This role requires collaboration across functions and engagement with regulatory bodies.