Principal Test Method Engineer (Medical Devices)

Location: Mounds View, Minnesota, United States; hybrid work with a minimum of 4 days per week onsite and up to 10% travel

Salary: $132,000–$198,000 USD per year, plus eligible short-term incentive compensation

Company

hirify.global develops healthcare technologies focused on alleviating pain, restoring health, and extending life.

What you will do

• Lead validation of design verification test methods for new complex electro-mechanical medical devices.
• Translate design inputs and clinical use conditions into reliable, repeatable test methods with cross-functional partners.
• Develop and validate custom test equipment and fixtures, including supplier coordination.
• Manage capital equipment procurement and financial tracking for equipment and validation activities.
• Design and execute validation studies using measurement system analysis, gage R&R, ANOVA, and probability of misclassification.
• Coordinate extended teams and test laboratories, investigate issues, communicate progress, and support project milestones.

Requirements

• Bachelor’s degree in a technical field with at least 7 years of technical experience, or an advanced technical degree with at least 5 years of experience.
• Experience with Measurement System Analysis and Design of Experiments.
• Knowledge of test method development, design for Six Sigma, design controls, equipment or process validation, and medical-device standards.
• Experience managing complex datasets and performing statistical analysis.
• Ability to work onsite in Mounds View, Minnesota at least 4 days per week.
• U.S. work authorization is required unless eligible for sponsorship under the Principal-level sponsorship policy.

Nice to have

• Electrical engineering knowledge.
• Project management experience.
• Medical device industry experience.
• Familiarity with FDA 21 CFR Part 820 cGMP, ISO 13485, ISO 10012, and ISO 17025.

Culture & Benefits

• Purpose-driven work developing technologies for patients across global healthcare markets.
• Health, dental, and vision insurance, plus health and flexible spending accounts.
• Paid time off, paid holidays, disability coverage, life insurance, and employee assistance programs.
• 401(k) plan with employer contribution and match, employee stock purchase plan, and incentive plans.
• Tuition assistance or reimbursement and a global well-being program.