Senior Software Engineering Program Manager (MedTech)

TL;DR

Senior Software Engineering Program Manager (MedTech): Drives the evolution of hirify.global's product development processes, focusing on Software Design Control and leading large-scale initiatives for quality and regulatory compliance. Focus on applying systems engineering principles to coordinate complex medical device development and embedding best practices in technical rigor and execution.

Location: On-site at one of hirify.global's North America sites: Mounds View, MN; Irvine, CA; Tempe, AZ; Lafayette, CO; Danvers, MA; Billerica, MA; Memphis, TN; Jacksonville, FL; Fort Worth, TX; or North Haven, CT. Compensation and benefits are solely for candidates hired within the United States.

Salary: $149,600.00 – $224,400.00 USD (yearly).

Company

hirify.global is a global leader in healthcare technology, boldly tackling challenging health problems by innovating and finding solutions to alleviate pain, restore health, and extend life.

What you will do

• Lead enterprise-wide initiatives focusing on Design, Reliability & Manufacturability (DRM) for product quality and regulatory compliance across hirify.global Operating Units.
• Guide cross-functional teams through the Product Development Process (PDP) with an emphasis on positive design control outcomes and regulatory adherence.
• Serve as a subject matter expert in CAPA and Post-Market Surveillance (PMS), integrating field performance insights into early design phases.
• Apply systems engineering principles to coordinate complex, multi-disciplinary product development efforts from concept through commercialization.
• Maintain deep familiarity with medical device design control regulations (e.g., FDA 21 CFR Part 820, ISO 13485, IEC 62304) and provide expert guidance.
• Provide hands-on coaching to engineering, quality, and cross-functional teams to strengthen Software Design Control maturity.

Requirements

• Bachelor’s Degree with 7+ years or Advanced Degree with 5+ years of experience in Quality and/or Development.
• 5+ years of managerial experience.
• Working knowledge of Quality System Regulations (QSR 21 CFR 820) and ISO 13485.
• Working knowledge of Software Development Standards (IEC 62304, IEC 82304, IEC 81001-5-1).
• Experience with process validation, statistical methods, risk management, and software engineering best practices.

Nice to have

• Experience with traditional staged and incremental/Agile software development life cycles.
• Green Belt Six Sigma/DRM Training/Certification.
• Experience with Software & Systems Reliability tools and methodologies (e.g., IEEE-1633).
• Experience in the application of artificial intelligence/machine learning tools and methods to software quality systems.
• Experience in the application of secure software development lifecycles and frameworks.

Culture & Benefits

• Competitive salary and flexible benefits package.
• Comprehensive health, dental, and vision insurance, HSA, FSA.
• 401(k) plan with employer contribution and match.
• Paid time off, paid holidays, and employee stock purchase plan.
• Commitment to fostering professional growth and cross-functional collaboration.
• Opportunity to impact patients worldwide with life-changing medical technology.