Principal Engineer (Medtech)

Location: Round Lake, Illinois, United States; hybrid work with a required minimum number of onsite days per week. Applicants must be authorized to work for any employer in the United States.

Base salary: $112,000–$154,000 annually.

Company

hirify.global develops healthcare products and solutions focused on saving and sustaining lives, including IV solutions and delivery systems.

What you will do

• Lead product and process development initiatives for IV solutions and delivery systems.
• Assess risks related to materials, manufacturing processes, patient safety, and product quality.
• Evaluate and implement non-DEHP materials and alternative packaging solutions.
• Lead investigations and mitigation strategies for nitrosamine and other impurity risks.
• Partner with Quality, Regulatory Affairs, R&D, Operations, and Supplier Quality teams.
• Oversee validation, stability, compatibility, extractables/leachables studies, regulatory submissions, audits, and complex change management while maintaining supply continuity.

Requirements

• B.S. in Engineering and 7+ years of engineering experience in a regulated industry such as medical device, pharmaceutical, biotech, healthcare, or related manufacturing.
• Experience leading cross-functional projects involving product development, manufacturing, quality, and regulatory teams.
• Strong knowledge of risk management, validation, design controls, and change management.
• Experience with materials, packaging, container-closure systems, and product lifecycle management.
• Familiarity with FDA, GMP, ISO, and global regulatory requirements.
• Ability to lead complex technical investigations and implement corrective and preventive actions (CAPAs).
• Authorization to work for any employer in the United States is required; employment visa sponsorship is not available.

Culture & Benefits

• Flexible workplace policy with required onsite collaboration.
• Medical and dental coverage starting on day one, plus life, accident, disability, and business travel insurance.
• 401(k) retirement savings plan with employee contributions and company matching, employee stock purchase plan, and flexible spending accounts.
• Educational assistance, paid holidays, 20–35 days of paid time off based on length of service, family and medical leave, and paid parental leave.
• Additional commuting, childcare, employee assistance, and employee discount benefits.