Lead Mechanical Design Engineer, Medical Devices

Agiliti Health, Inc.; Wauwatosa (WI); On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

Health Insurance

401K Saving Plan

Paid Time Off

Tuition Reimbursement

Wellness programs

Job summary

Agiliti Health, Inc. seeks a Senior Mechanical Engineer to lead multiple complex medical device projects at the Milwaukee Design Center.

You will collaborate with engineering, quality, regulatory, and certification teams to drive design, ensure system integration, and achieve quality, cost, and delivery goals. The role requires a BS in engineering with 10+ years in relevant industries, strong 3D CAD skills, and experience with ISO/FDA certifications.

Qualifications

• Bachelor's degree in Engineering required.
• 10+ years of experience designing products in medical, consumer, automotive, or aerospace industry.
• Experience leading collaborative teams through complex projects.
• Experience designing for agency certifications (ISO, IEC, AAMI, UL, CE, CISPR, FCC, FDA).
• Familiar with Jira or similar project management tools.
• Ability to travel up to 50% (Domestic and International).

Responsibilities

• Act as technical lead on multiple complex, integrated projects utilizing advanced engineering design methods.
• Ensure systems integration and continuity of system architecture roadmap across multiple discrete projects.
• Develop and drive an innovative design process to ensure development activities meet standards for quality, cost, and delivery.
• Create electro-mechanical part and assembly designs using parametric 3D CAD tools with emphasis on mechanical function and regulatory compliance.
• Contribute to product risk analysis, usability, verification, and certification test efforts for medical products.
• Oversee development of prototype mockups and fabrication of working prototypes.
• Coordinate with Leadership, Product Development, Clinical Verification, Quality/Regulatory, and Certification teams.
• Review tooling designs and support mass production during design transfer and production ramp.
• Design and review manufacturing test fixtures and procedures and analyze field returns for corrective actions.
• Lead project updates and design reviews with visual materials for internal and supplier communications.
• Identify areas for IP protection and work with legal to develop patent applications.
• Participate in ISO and AAMI standards development.

Skills

3D CAD

FEA

Analytical thinking

Project management

Communication skills

Education

BS Engineering

Tools

Inventor

SolidWorks

Job description

Agiliti Health, Inc. seeks a Senior Mechanical Engineer to lead multiple complex medical device projects at the Milwaukee Design Center.

You will collaborate with engineering, quality, regulatory, and certification teams to drive design, ensure system integration, and achieve quality, cost, and delivery goals. The role requires a BS in engineering with 10+ years in relevant industries, strong 3D CAD skills, and experience with ISO/FDA certifications.