Sr Design Assurance Engineer (Software Medical Devices)

Location: Hybrid role based in Bethlehem, Pennsylvania, United States; primarily office-based with occasional work in laboratory and manufacturing settings.

Salary: $92,215–$115,300 per year

Company

hirify.global develops and manufactures medical products and services, including infusion therapy, pain management, nutrition, pharmacy compounding, ostomy and wound care, and dialysis solutions. The company focuses on patient, clinician, and environmental safety and operates globally as part of the hirify.global Group.

What you will do

• Lead quality and compliance activities for medical devices with embedded and standalone software.
• Provide Quality Engineering support for new product development, design changes, and OEM projects.
• Lead Design Control, Verification and Validation, and Risk Management activities.
• Develop and review quality plans, validation plans, design documentation, traceability matrices, and risk assessments.
• Analyze quality metrics, lead root-cause investigations and CAPA activities, and drive continuous improvement.
• Partner with R&D, Regulatory Affairs, Manufacturing, and external stakeholders and present quality updates to leadership.

Requirements

• Bachelor’s degree in Engineering or a related technical discipline.
• 6+ years of related experience in a regulated industry.
• Experience with Design Controls, Verification and Validation, and Risk Management.
• Strong knowledge of medical device software and quality regulations.
• Experience with root-cause analysis, CAPA, and continuous improvement methodologies.
• Strong communication, collaboration, and leadership skills.

Nice to have

• Expertise in medical device software development and cybersecurity.
• Hands-on experience with IEC 62304, IEC 60601, IEC 62366, and ISO 14971.
• ASQ CQE, CSQE, or another relevant quality certification.
• Experience supporting global product development teams and regulatory submissions.
• Project leadership and cross-functional influencing experience.

Culture & Benefits

• Collaborative work across Quality, R&D, Manufacturing, and Regulatory teams.
• Opportunity to influence product quality, patient safety, and healthcare innovation.
• Healthcare benefits and a 401(k) plan.
• Tuition reimbursement.
• Continuous improvement supported through the Sharing Expertise initiative.