Hybrid Senior Design Assurance Engineer – Medical Devices

Boston Scientific; Marlboro (MA); Hybrid; USD 82,000 - 156,000; Full time

Job summary

Boston Scientific in Marlboro, MA, is seeking a Design Assurance Engineer to support medical devices across development and sustaining activities. You will develop and maintain quality engineering methodologies to meet regulatory requirements and drive improvements.

The role requires collaboration with global teams, familiarity with design controls, CAPA, and post-market activities; hybrid work with in-office presence three days a week. Related relocation or visa details are not provided.

Qualifications

• Bachelor's degree in Biomedical Engineering, Mechanical Engineering or related field.
• 3+ years of medical device engineering experience.
• Knowledge of US and international medical device requirements (21 CFR 820, EN ISO 13485, EN ISO 14971, EU MDR).
• Ability to travel ~10–20%.

Responsibilities

• Provide quality and compliance input for post market activities (design changes, supplier audits, safety certification, CAPAs, Field Actions).
• Apply structured problem-solving methods (5 Whys, Ish-Is-Not, DMAIC) to quality issues.
• Support design controls and project decisions (DCA, DV/ V, Design Reviews, Usability Testing).
• Champion compliance with policies, SOPs, and work instructions.
• Support quality metrics, data analysis, and regulatory audits.

Skills

Strong communication

Presentation skills

Global collaboration

Education

Bachelor's in Biomedical/Mechanical Eng or related

Job description

Boston Scientific in Marlboro, MA, is seeking a Design Assurance Engineer to support medical devices across development and sustaining activities. You will develop and maintain quality engineering methodologies to meet regulatory requirements and drive improvements.

The role requires collaboration with global teams, familiarity with design controls, CAPA, and post-market activities; hybrid work with in-office presence three days a week. Related relocation or visa details are not provided.