Sr. Mechanical Engineer (Medical Devices)

Location: Newark, Delaware, United States

Annual base salary: $97,600–$152,700, plus bonus eligibility.

Company

hirify.global develops breast and skeletal health products and provides training and career development for employees.

What you will do

• Lead and support investigations of field complaints, non-conformances, manufacturing issues, and supplier quality problems.
• Apply root cause analysis methods such as 5-Why, Fishbone, and FMEA, and translate findings into verified engineering changes.
• Own or support CAPAs, including investigation, containment, corrective action implementation, and effectiveness checks.
• Manage end-of-life component, material, and supplier changes, including alternate-part qualification and lifecycle planning.
• Author and review ECOs, validation and verification protocols, reports, and sustaining engineering documentation.
• Perform mechanical analysis using CAD/CAE and GD&T while managing multiple concurrent investigations and projects.

Requirements

• Bachelor’s degree in Mechanical Engineering.
• 5+ years of experience in a relevant role.
• Strong understanding of mechanical design and analysis.
• Excellent analytical, problem-solving, troubleshooting, communication, and prioritization skills.
• Ability to make trade-off decisions, manage ambiguity, and coordinate with Supplier Quality, Manufacturing, Quality, Regulatory, and Complaint Handling.

Nice to have

• Experience in medical device design.
• Functional understanding of Geometric Dimensioning and Tolerancing (GD&T).

Culture & Benefits

• Comprehensive onboarding training and continued professional development.
• Competitive salary and annual bonus eligibility.
• Focus on maintaining product availability, quality, compliance, and performance throughout the commercial lifecycle.