Senior Mechanical Engineer

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

Benefits offered by this job

401k

Health insurance

Dental

Vision

Job summary

Actalent is seeking a Sr. Mechanical Engineer to design and develop catheter-based devices in Milwaukee, WI, with hybrid collaboration across global teams.

The role emphasizes design transfer, process optimization, and thorough documentation supporting regulated medical device development. You will drive IQ/OQ/PQ validation, maintain DHF, and mentor engineers while coordinating with the Vietnam engineering team.

Qualifications

• BSME degree from an accredited program.
• Hands-on experience with catheter design and polymer processes.
• Experience with IQ/OQ/PQ protocols and design history file.

Responsibilities

• Design and develop catheter-based devices from concept to design transfer.
• Optimize polymer processes including injection molding and balloon forming.
• Create 3D models and drawings with GD&T per ASME Y14.5.
• Lead design validation testing and process verification activities.
• Manage design controls, risk management, and DHF documentation.
• Coordinate with remote Vietnam team across time zones.

Skills

CAD software

GD&T

Statistical tools

Leadership of technical workstreams

Education

Bachelor's degree in Mechanical Engineering

Tools

Autodesk Inventor

Job description

Job Description

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.

Job Title: Sr. Mechanical Engineer

Job Description

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.

Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.

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 10, 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.