Post Market Surveillance Engineer 2 (Medical Devices)

Location: Marlborough, MA, United States

Annualized base salary: $78,000–$122,100, bonus eligible

Company

hirify.global develops and supports medical device products and provides training and ongoing professional development.

What you will do

• Conduct complaint evaluations, investigations, root cause analysis, risk assessments, and trend analysis for on-market medical devices.
• Lead cross-functional teams in determining corrective actions, implementing improvements, and supporting CAPA decisions.
• Assess product and project documentation for compliance and support change control activities, including documentation updates, testing, verification, validation, and impact assessments.
• Communicate investigation findings, recommended changes, and implementation scope to stakeholders and leadership.
• Present product quality metrics, investigation outcomes, and recommended resolutions to leadership.
• Coordinate Health Risk Assessments, support Quality Investigation Review boards, and conduct field investigations at customer sites with sales, service, and field-based teams.

Requirements

• Bachelor’s degree in Engineering required; Mechanical, Electrical, Biomedical, or Biomechanical Engineering preferred.
• 2–5 years of relevant engineering experience.
• Knowledge of medical device quality systems and regulatory requirements, including FDA Quality System Regulations, Design Controls, ISO 13485, EU MDR, and risk management standards.
• Knowledge of post-market quality processes, including complaint handling, investigations, risk assessment, Health Risk Assessments, CAPA evaluation, and change control.
• Ability to work collaboratively across functions, take ownership of investigations, prioritize complaints based on risk and data, and operate with intermediate autonomy.
• Strong accountability, compliance mindset, attention to detail, judgment, and communication skills.

Nice to have

• Experience in an FDA-regulated industry.
• Experience in root cause analysis, product development, R&D, or medical device quality engineering.
• Experience supporting post-market medical devices, complaint investigations, CAPA evaluation, and regulated product changes.
• Knowledge of test method validation, root cause failure analysis, statistical methods, design of experiments, reliability, electrical safety, sterilization, packaging, biocompatibility, and requirements analysis.

Culture & Benefits

• Comprehensive training is provided when joining, with continued development and training throughout the career.
• The role is bonus eligible.
• Equal opportunity employment includes disability and veteran status.