Research Scientist I - E&L (Medical Devices)

Location: Oakdale, Minnesota, United States; minimum 3 days per week onsite

Salary: $128,000–$176,000 annually, with potential discretionary bonuses

Company

hirify.global develops vital organ therapies, digital solutions, and advanced services, with a focus on kidney care and dialysis.

What you will do

• Plan and independently execute laboratory studies in mass spectroscopy and extractables and leachables (E&L) at internal or external laboratories.
• Lead multiple E&L studies as study director, including hands-on wet chemistry and GC, LC, and other appropriate mass spectroscopy methods.
• Develop risk-based E&L strategies for medical devices and drug products within regulatory frameworks.
• Perform change-control impact and gap assessments and prepare technical rationales, testing strategies, and related documentation.
• Collaborate with materials, biocompatibility, toxicology, regulatory, quality, preclinical, product design, and project management specialists.
• Author internal reports and regulatory submissions supporting product safety, quality, and compliance.

Requirements

• Bachelor’s degree in a scientific discipline, preferably analytical or organic chemistry, plus 10+ years of relevant experience; or MS plus 7+ years; or PhD plus 3+ years.
• Hands-on expertise in E&L testing, from wet chemistry sample preparation through mass spectroscopy using GC and LC methods.
• Experience directing E&L studies and delivering cross-functional projects on time and within budget.
• Knowledge of regulatory expectations and ability to write concise E&L reports for health-authority submissions.
• Experience with change control in a GMP environment and applying risk-management methods.
• Ability to work onsite at least three days per week in Oakdale, Minnesota.

Culture & Benefits

• Flexible workplace policy supporting in-person collaboration.
• Medical, dental, and vision coverage beginning on day one for eligible employees.
• Life, disability, accident, and business travel insurance.
• 401(k) retirement plan, financial education, and investment resources.
• Paid holidays, 20–35 days of paid time off based on tenure, family and medical leave, and paid parental leave.
• Educational assistance, commuting, childcare, employee discount, and employee assistance benefits.