Principal Design QA Engineer - Endoscopy (Hybrid)

Boston Scientific Gruppe; Marlborough (MA); Hybrid; USD 107,000 - 203,000; Full time

Job summary

Boston Scientific Marlborough, MA seeks a Principal Design Quality Assurance Engineer for Endoscopy. This senior role leads quality deliverables, regulatory compliance, and continuous improvement across design projects, including NPD, sustaining and life-cycle initiatives.

The ideal candidate has 8+ years in medical devices, deep knowledge of 21 CFR 820, EU MDR, ISO 13485/14971, and travels 10-20%. Hybrid work with at least three days onsite weekly.

Qualifications

• Bachelor of Science in Biomedical Engineering, Mechanical Engineering or related degree.
• 8+ years of medical device engineering experience.
• In-depth knowledge of US and International medical device requirements including 21 CFR part 820, Medical Device Directive (MDD) / Medical Device Regulation (EU MDR), EN ISO 13485 and EN ISO 14971.
• Travel approximately 10-20%.

Responsibilities

• Acts as the primary voice for quality within cross-functional teams, influencing project direction and regulatory compliance.
• Leads the execution of Quality Deliverables such as Project Design & Development Plan, Field Assessment Plan, Design Change, and Design & Usability Validation Plans; leads risk management deliverables.
• Interfaces with senior management and may lead cross-divisional quality projects.
• Leverages deep technical knowledge to guide complex problem solving and achieve corrective actions.
• Mentors engineers and promotes a culture of learning and technical excellence.
• Builds cross-department relationships and communicates quality priorities to stakeholders.
• Supports internal and external regulatory audits as audit-facing SME.

Skills

Quality engineering principles

Design controls

Risk management

Problem-solving methodologies

Leadership

Education

Bachelor of Science in Biomedical Engineering or Mechanical Engineering or related degree

Tools

Minitab

Job description

Boston Scientific Marlborough, MA seeks a Principal Design Quality Assurance Engineer for Endoscopy. This senior role leads quality deliverables, regulatory compliance, and continuous improvement across design projects, including NPD, sustaining and life-cycle initiatives.

The ideal candidate has 8+ years in medical devices, deep knowledge of 21 CFR 820, EU MDR, ISO 13485/14971, and travels 10-20%. Hybrid work with at least three days onsite weekly.