Senior Design Assurance Engineer (Medical Devices)

Location: Mounds View, Minnesota, United States of America; on-site presence required at least 4 days per week. Less than 10% travel is required.

Salary: $107,200–$160,800 per year in U.S. locations, excluding Puerto Rico and specific locations in California.

Company

hirify.global develops healthcare technologies designed to alleviate pain, restore health, and extend life, serving patients in more than 150 countries.

What you will do

• Represent Design Assurance on product development projects and collaborate with cross-functional teams.
• Lead design verification strategy and execution in alignment with project milestones.
• Perform reliability analyses across requirements, architecture, interfaces, and design using failure analysis, failure trending, and reliability forecasting.
• Lead risk management activities and ensure compliance with FDA, ISO 14971:2019, and ISO 13485:2016 requirements.
• Lead complex test method validation activities, including study design, sample size definition, statistical analysis, operator training, and reporting.
• Identify and resolve reliability and technical risks while driving continuous improvement in Design Assurance.

Requirements

• Requires unrestricted U.S. work authorization at the time of hire and throughout employment; sponsorship is not available for this role.
• Baccalaureate degree and at least 4 years of relevant experience, or Master's degree and at least 2 years of relevant experience, or PhD with no required experience.
• Experience with design controls, risk management, design verification, and medical device development.
• Knowledge of FDA 21 CFR Part 820 cGMP, ISO 13485, and ISO 14971:2019.
• Experience managing complex datasets and performing statistical analysis, including crossed gage R&R, ANOVA, and probability of misclassification.
• Ability to work on site in Mounds View at least 4 days per week and travel less than 10%.

Nice to have

• Project management experience.
• Experience with test method development, Design for Six Sigma, pre-clinical evaluations, system requirements development, and capital equipment.

Culture & Benefits

• Regular employment with health, dental, vision, life, disability, and retirement benefits.
• 401(k) plan with employer contribution and match.
• Paid time off and paid holidays.
• Tuition assistance or reimbursement.
• Employee Stock Purchase Plan, incentive plans, and well-being resources.