Senior Design Assurance Engineer

Boston Scientific-posted 4 months ago
$86,600 - $164,500/Yr
Full-time • Senior
Hybrid • Waltham, MA
5,001-10,000 employees
Merchant Wholesalers, Durable Goods
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We have a high-impact opportunity for a Senior Design Assurance Engineer to lead design assurance efforts for the Opal system, a critical medical device platform. This role requires a self-driven professional capable of independently managing complex quality and compliance activities across hardware and software domains. The Senior Engineer will drive quality initiatives, mentor junior engineers, and serve as a key resource in cross-functional teams to ensure product safety, regulatory compliance, and exceptional software quality.

  • 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.
  • 401k
  • health_insurance
  • dental_insurance
  • vision_insurance
  • life_insurance
  • disability_insurance
  • tuition_reimbursement
  • paid_holidays
  • employee_discount_programs
  • professional_development
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