Senior Mechanical Engineer, Catheter Devices

ACTalent; Milwaukee (WI); Hybrid; USD 100,000 - 130,000; Full time

Benefits offered by this job

401k plan

Health benefits (medical, dental, etc)

Vision benefits

Job summary

Actalent is seeking a Sr. Mechanical Engineer in Milwaukee to lead design and development of catheter-based devices, overseeing polymer processes, testing, and design controls. This hybrid role collaborates with global teams and mentors junior staff.

Responsibilities include design transfer, process validation, and equipment tooling leadership, with a strong emphasis on regulatory compliance and yield improvements.

Qualifications

• Hands-on experience with catheter design and polymer processes required.
• Experience in authoring and executing IQ/OQ/PQ protocols.
• Proficiency in CAD with strong GD&T knowledge.
• Working knowledge of design controls under 21 CFR Part 820 and ISO standards.

Responsibilities

• Design and develop catheter-based devices from concept to design transfer.
• Optimize polymer processes including injection molding, extrusion, and balloon forming.
• Create 3D models and detailed drawings using GD&T standards.
• Author and execute process validation protocols and reports.
• Specify and implement new manufacturing equipment and tooling.
• Develop and lead test method validation and design verification testing.
• Manage design control deliverables and risk management activities.
• Support design transfer and early production phases.
• Coordinate with international engineering teams.
• Mentor junior engineers and technicians.

Skills

Catheter design experience

Polymer processes experience

IQ/OQ/PQ protocols experience

GD&T proficiency

Statistical tools

Design controls knowledge

Leadership of technical workstreams

Education

BSME

Tools

Autodesk Inventor

Job description

Actalent is seeking a Sr. Mechanical Engineer in Milwaukee to lead design and development of catheter-based devices, overseeing polymer processes, testing, and design controls. This hybrid role collaborates with global teams and mentors junior staff.

Responsibilities include design transfer, process validation, and equipment tooling leadership, with a strong emphasis on regulatory compliance and yield improvements.