Tooling Design Engineer (Inspection & Metrology) - Medical Device Industry

Job Summary

The Tooling Design Engineer is responsible for qualifying, verifying, and supporting inspection tools used in a regulated medical device manufacturing environment. This role ensures inspection tools meet engineering, dimensional, and performance requirements prior to release and throughout their lifecycle. The engineer supports measurement system analysis (MSA), executes gage R&R studies, and contributes to out‑of‑tolerance investigations to ensure accurate, repeatable, and compliant measurement systems.

The position works cross‑functionally with Inspection Tool Design, Quality Engineering, Manufacturing, and Incoming Inspection teams to support tool development, validation, audits, and continuous improvement. Success in this role requires strong hands‑on metrology experience, the ability to interpret engineering drawings and GD&T, and a high level of attention to detail and documentation accuracy. All activities are performed in compliance with ISO 13485, FDA 21 CFR 820, and internal quality system procedures.

Key Responsibilities

•\tDesign simple and moderately complex inspection tools, gauges, and fixtures to support in-process, final, and incoming inspections.

•\tTranslate product drawings, tolerances, and GD&T requirements into effective inspection methods.

•\tDesign inspection tools that are accurate, repeatable, ergonomic, and practical for routine manufacturing use.

•\tInterpret GD&T per ASME Y14.5 and apply it to inspection tool design.

•\tSupport design-for-inspectability discussions with Product Design Engineering.

•\tEnsure inspection methods properly align with datums, feature controls, and tolerance intent.

•\tSupport qualification of inspection tools through Gage R&R / MSA activities.

•\tEnsure inspection tools meet repeatability and accuracy requirements based on product risk.

•\tAssist with out-of-tolerance and measurement system investigations related to inspection tools.

•\tWork with Quality Engineering to ensure inspection tools are fit-for-purpose.

•\tCreate and release engineering drawings and specifications for inspection tools and fixtures.

•\tDefine critical dimensions, tolerances, materials, and finishes for inspection tooling.

•\tMaintain documentation in compliance with document control and change management procedures.

•\tApply basic knowledge of materials and mechanical behavior when designing inspection tools

•\tSelect appropriate materials for inspection tools based on accuracy, environment, and usage.

•\tCollaborate with Product Design Engineering to clarify inspection intent and critical features.

•\tSupport Manufacturing and Quality Engineering during process validation and product release activities.

•\tAssist Supplier Quality and Incoming Inspection by developing appropriate inspection tools and methods.

•\tEnsure inspection tools and activities comply with ISO 13485 and FDA 21 CFR 820.

•\tFollow internal procedures for design control, validation, and inspection tooling management.

•\tSupport audits related to inspection and measurement systems.

Required Qualifications

•\tBachelor’s degree in Engineering

•\t3+ years of experience designing inspection tooling within a regulated environment such as Aerospace or Medical Device

•\tWorking knowledge of GD&T (ASME Y14.5).

•\tExperience supporting Gage R&R or MSA activities.

•\tAbility to create clear engineering drawings for tools or fixtures.

•\tFamiliarity with medical device manufacturing and inspection practices.

•\tProficiency in SolidWorks

•\tFluent in English (written and verbal)

Job Type & Location

This is a Contract to Hire position based out of Miami, FL.

Pay and Benefits

The pay range for this position is $30.00 - $45.00/hr.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision • Critical Illness, Accident, and Hospital • 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available • Life Insurance (Voluntary Life & AD&D for the employee and dependents) • Short and long-term disability • Health Spending Account (HSA) • Transportation benefits • Employee Assistance Program • Time Off/Leave (PTO, Vacation or Sick Leave)

Workplace Type

This is a fully onsite position in Miami,FL.

Application Deadline

This position is anticipated to close on Feb 6, 2026.

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 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

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 due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.