Senior Mechanical Design Engineer (Medtech)

TL;DR

Senior Mechanical Design Engineer (Medtech): Designing tooling and fixturing for cutting-edge process technologies to create quality medical products with an accent on implantable cardiac and neuromodulation devices. Focus on creating innovative, lean, and cost-effective mechatronic systems and ensuring regulatory compliance for FDA submissions.

Location: Onsite in Tempe, Arizona, USA (required 4 days a week)

Salary: $106,400 - $159,600

Company

Global leader in healthcare technology dedicated to alleviating pain, restoring health, and extending life.

What you will do

• Research, design, and validate mechanical and electromechanical devices, including robots and resonance systems.
• Develop innovative tooling and fixturing solutions to support 24/7 medical device manufacturing operations.
• Prepare regulatory submission-ready documentation for the FDA and other governing bodies.
• Lead and review the work of technical teams to ensure project execution according to the technical plan.
• Perform risk and failure mode assessments, conducting safety testing and implementing mitigations.
• Execute structured experiments utilizing Six Sigma methodologies to drive data-based decisions.

Requirements

• Bachelor's degree with 4+ years of experience, Master's with 2+ years, or a PhD.
• Unrestricted U.S. work authorization required (sponsorship is only available for Principal-level roles).
• Experience designing mechanical, electromechanical, and mechatronic systems.
• Knowledge of fabrication processes using metals, plastics, and ceramics.
• Ability to perform job functions in accordance with GMP and ISO standards.

Nice to have

• GD&T certification.
• DRM or DFSS Green Belt or Black Belt certification.
• Experience in the medical industry or other FDA-regulated environments.

Culture & Benefits

• Competitive salary and eligibility for the hirify.global Incentive Plan (MIP).
• Comprehensive insurance package including health, dental, vision, HSA, and FSA.
• 401(k) plan with employer contribution and matching.
• Employee Stock Purchase Plan and Non-qualified Retirement Plan Supplement.
• Tuition assistance/reimbursement and global well-being program (Simple Steps).
• Paid time off and paid holidays.