Product Quality Engineer 2 (Medical Devices)

Location: Marlborough, MA, United States

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

Company

hirify.global develops medical devices and provides products subject to medical-device quality and regulatory requirements.

What you will do

• Lead complaint evaluations, investigations, root cause analysis, risk assessments, and trend analysis for on-market medical devices.
• Lead cross-functional teams in corrective actions, product improvements, and CAPA decisions.
• Assess product and project documentation for compliance and support change-control activities, including testing, verification, validation, and impact assessments.
• Communicate investigation findings, recommended changes, implementation scope, quality metrics, and resolutions to stakeholders and leadership.
• Coordinate Health Risk Assessments and support Quality Investigation Review boards.
• Perform 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, trends, data, and business impact, and operate with intermediate autonomy.
• Effective communication with technical teams, leadership, and field-based partners, with strong accountability, compliance focus, judgment, and attention to detail.

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, or requirements analysis.

Culture & Benefits

• Comprehensive training on joining and continued development and training throughout the career.
• Role is bonus eligible.
• Equal Opportunity Employer inclusive of disability and veterans.

Hiring process

• Agency submissions are considered only when the agency has a current executed hirify.global Agency Agreement and has been invited by a hirify.global Recruiter.
• Agencies must send resumes to the hirify.global Recruiter under the stated agreement terms.