Senior Design Assurance Engineer at Boston Scientific Corporation Malaysia

Waltham, Massachusetts, United States -

Full Time

Start Date

Immediate

Expiry Date

02 Mar, 26

Salary

0.0

Posted On

02 Dec, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Design Control, Risk Management, Quality System Regulations, Software Quality Assurance, Root Cause Analysis, CAPA Investigations, Software Validation, Software Verification, Mentorship, Project Management, Agile Development, Communication, Problem Solving, FMEAs, Hazard Analysis, IEC 62304

Industry

Medical Equipment Manufacturing

Description

Independently lead design control activities for the Opal system, including planning, execution, and documentation of risk management, design verification, and validation efforts, with a strong focus on software quality assurance. Collaborate closely with R&D, regulatory, manufacturing, and clinical teams to provide expert guidance on design assurance and compliance matters throughout the product lifecycle. Own and maintain comprehensive risk management files (Hazard Analysis, FMEAs), ensuring robust coverage of both hardware and software risks, applying advanced risk mitigation strategies. Lead root cause investigations and resolution of CAPAs, NCEPs, and complaints, driving corrective actions and preventive measures with minimal oversight. Champion software quality initiatives by enforcing compliance with IEC 62304, ISO 13485, and other relevant standards; lead software validation and verification activities including test planning, execution, and traceability. Provide mentorship and guidance to junior engineers on design assurance best practices, regulatory requirements, and software quality processes. Proactively identify gaps and opportunities for continuous improvement in design assurance processes, tools, and documentation. Act as a primary point of contact for design assurance during internal and external audits and regulatory inspections. Effectively manage multiple priorities and projects independently, demonstrating strong decision-making skills in ambiguous situations. Bachelor's degree in Materials, Mechanical, Electrical, Computer Science, Software Engineering, Biomedical Engineering, or related technical discipline. 6+ years of experience in Quality Assurance, Design Assurance, Software Quality, or related roles in the medical device industry. Demonstrated expertise in Design Controls, Risk Management (ISO 14971), Quality System Regulations (21 CFR 820), with deep knowledge of software quality standards (IEC 62304) and software validation principles. Proven ability to independently lead complex design assurance projects, including software quality assurance activities, from inception through completion. Experience developing and maintaining risk documentation such as FMEAs and Hazard Analyses with a software risk focus. Strong problem-solving skills with experience leading root cause analysis and CAPA investigations. Excellent communication skills, capable of influencing stakeholders at all levels and leading cross-functional initiatives. Ability to thrive in a fast-paced environment and navigate ambiguity with sound judgment. Experience mentoring or leading junior engineers in design assurance or software quality. Hands-on experience with software testing frameworks, static code analysis tools, or software risk analysis tools. Prior experience working on or supporting the Opal system or similar complex medical device platforms. Strong project management skills and familiarity with agile development methodologies.

Responsibilities

Independently lead design control activities for the Opal system, focusing on risk management, design verification, and validation efforts. Collaborate with various teams to ensure compliance and provide expert guidance throughout the product lifecycle.