Miami, FL, 33126, USA
10 days ago
Tool Design Engineer
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 • Design simple and moderately complex inspection tools, gauges, and fixtures to support in-process, final, and incoming inspections. • Translate product drawings, tolerances, and GD&T requirements into effective inspection methods. • Design inspection tools that are accurate, repeatable, ergonomic, and practical for routine manufacturing use. • Interpret GD&T per ASME Y14.5 and apply it to inspection tool design. • Support design-for-inspectability discussions with Product Design Engineering. • Ensure inspection methods properly align with datums, feature controls, and tolerance intent. • Support qualification of inspection tools through Gage R&R / MSA activities. • Ensure inspection tools meet repeatability and accuracy requirements based on product risk. • Assist with out-of-tolerance and measurement system investigations related to inspection tools. • Work with Quality Engineering to ensure inspection tools are fit-for-purpose. • Create and release engineering drawings and specifications for inspection tools and fixtures. • Define critical dimensions, tolerances, materials, and finishes for inspection tooling. • Maintain documentation in compliance with document control and change management procedures. • Apply basic knowledge of materials and mechanical behavior when designing inspection tools • Select appropriate materials for inspection tools based on accuracy, environment, and usage. • Collaborate with Product Design Engineering to clarify inspection intent and critical features. • Support Manufacturing and Quality Engineering during process validation and product release activities. • Assist Supplier Quality and Incoming Inspection by developing appropriate inspection tools and methods. • Ensure inspection tools and activities comply with ISO 13485 and FDA 21 CFR 820. • Follow internal procedures for design control, validation, and inspection tooling management. • Support audits related to inspection and measurement systems. Required Qualifications • Bachelor’s degree in Engineering • 3+ years of experience designing inspection tooling within a regulated environment such as Aerospace or Medical Device • Working knowledge of GD&T (ASME Y14.5). • Experience supporting Gage R&R or MSA activities. • Ability to create clear engineering drawings for tools or fixtures. • Familiarity with medical device manufacturing and inspection practices. • Proficiency in SolidWorks • Fluent 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 (%20actalentaccommodation@actalentservices.com) for other accommodation options.
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