Senior Design Quality Assurance Engineer

Hims & Hers • Full-time • Minnetonka, Minnesota, United States • $95k - $110k / year • 1w ago

At Hims & Hers, we prioritize individual health journeys, crafting solutions that redefine healthcare accessibility. Our team blends innovative technology with empathetic care, focusing on tangible results in the health and wellness space.

Requirements

A Bachelor’s degree in Biomedical, Mechanical, Electrical Engineering, or a related field.
5 to 8+ years in medical device development, specifically within Quality or R&D.
Proven track record of owning design controls, having supported at least one FDA 510(k) submission.
In-depth knowledge of FDA design controls, ISO 13485, and ISO 14971.
Strong skills in statistical methods, risk management tools, and root cause analysis.
Experience in crafting complex protocols and validation reports.
Familiarity with electronic Quality Management Systems (QMS), preferably Qualio.
Excellent communication skills, both written and verbal.

Benefits

Competitive salary and equity options tailored to full-time roles.
Flexible leave policies including unlimited PTO and quarterly mental health days.
Comprehensive healthcare package encompassing medical, dental, and vision coverage.
Robust 401k plan with employer matching contributions.
Opportunities for professional development and offsite team retreats.
Employee Stock Purchase Program (ESPP) for added financial benefits.

You’ll Be a Great Fit If...

Your approach to problem-solving is rooted in thorough analysis and a commitment to safety.
You thrive in collaborative environments where influence and mentorship are part of your daily routine.
Detail-oriented planning and execution are second nature to you, especially in high-stakes situations.
You actively seek to enhance processes, continually looking for ways to improve design quality and compliance.
Regulatory challenges excite you, and you enjoy defending your work with clarity and confidence.

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