Senior Mechanical Engineer

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

Job Title: Sr. Mechanical Engineer

Design and develop catheter-based devices and components, including balloons, shafts, tips, and handle assemblies, from concept through design transfer. Develop and optimize devices and components for polymer processes such as injection molding, extrusion, balloon forming, bonding, tipping, and catheter assembly. Define process windows using DOE and statistical analysis. Create 3D models, detailed drawings, and tolerance stack-ups applying GD&T per ASME Y14.5. Author and execute process validation protocols and reports (IQ/OQ/PQ), and specify, qualify, and implement new manufacturing equipment and tooling. Develop test methods and fixtures, lead test method validation, and plan and execute design verification and validation testing. Own design control deliverables including design inputs/outputs, traceability, design reviews, and DHF documentation. Lead risk management activities per ISO, including dFMEA and pFMEA. Support design transfer and early production, resolving technical issues and driving yield and process capability improvements. Coordinate remotely with the Vietnam engineering team across time zones on design, process, and documentation tasks. Mentor junior engineers and technicians and serve as a technical resource across the department.

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.

Essential Skills

• Bachelor's degree in Mechanical Engineering (BSME).
• 510 years of engineering experience in medical devices or regulated industries.
• Hands‑on experience with catheter design and polymer processes.
• Experience in authoring and executing IQ/OQ/PQ protocols.
• Proficiency in CAD software with strong command of GD&T.
• Experience with test method development and statistical tools.
• Working knowledge of design controls under 21 CFR Part 820 and ISO standards.
• Ability to lead technical workstreams independently and communicate effectively.

Additional Skills & Qualifications

• Experience in new product development and manufacturing engineering.
• Proficiency with Autodesk Inventor or equivalent CAD software.
• Experience in a regulated environment.

Work Environment

This is a hybrid role that spans new product development and manufacturing engineering. The position requires collaboration with remote teams across different time zones, including coordination with an engineering team in Vietnam. The environment is regulated, involving adherence to industry standards and protocols. The role offers opportunities for mentoring junior staff and leading technical initiatives.

Job Type & Location

This is a Permanent position based out of Milwaukee, WI.

Pay And Benefits

The pay range for this position is $100000.00 - $130000.00/yr.

• 401k, health, dental, vision

Job Type & Location

This is a Permanent position based out of Milwaukee, WI.

Application Deadline

This position is anticipated to close on Nov 23, 2026.

Workplace Type

This is a fully onsite position in Milwaukee,WI.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email [e-mail] for other accommodation options.

San Francisco Fair Chance Ordinance

Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records.

Massachusetts Lie Detector

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Use of Artificial Intelligence (AI)

We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.