Job Description

Job Title: Manufacturing Fixture Engineer
Location: Draper, Utah (Onsite)
Experience: 5+ Years

Duration: 12+ Months Contract
Work Authorization: US Citizens, Green Card Holders, and H4EAD Only

We are seeking an experienced Manufacturing Fixture Engineer with a strong background in the design, development, and validation of assembly fixtures for medical device manufacturing . The role involves working closely with manufacturing and design teams to develop precision assembly and test fixtures for electromechanical medical systems. The engineer will serve as the primary onsite point of contact, ensuring seamless coordination between the customer, manufacturing engineers, and offshore design teams. This position requires deep technical expertise, hands-on CAD proficiency, and a thorough understanding of regulatory and quality standards applicable to medical device production.

• Develop fixture concepts, perform feasibility analysis, and create detailed design proposals for medical device assembly and test operations.

• Generate detailed 3D CAD models and 2D engineering drawings , ensuring adherence to design intent, manufacturing feasibility, and release processes.

• Conduct tolerance stack-up analysis and apply GD&T principles to achieve precision and reliability in fixture designs.

• Collaborate with manufacturing engineers to collect device and process data, review requirements, and deliver accurate design outputs.

• Coordinate and review work completed by offshore design teams , providing technical feedback and ensuring design quality and consistency.

• Support TFIQ (Test, Fixture, Inspection Qualification) activities, including report preparation and documentation per site protocols.

• Oversee project planning, scheduling, and timely delivery of all fixture design deliverables.

• Ensure all designs comply with applicable FDA , ISO 13485 , and GMP standards for medical devices.

• Participate in design reviews, risk assessments, and validation activities to verify fixture functionality and performance.

• Bachelor's or Master's degree in Mechanical Engineering , Biomedical Engineering , or related discipline.

• Minimum 5 years of engineering experience , with at least 3 years focused on fixture design in a medical device or high-precision manufacturing environment.

• Proficient in SolidWorks or Creo for 3D modeling and 2D drafting.

• Strong knowledge of GD&T , tolerance stack-up analysis , and material selection for precision tooling and fixtures.

• Familiarity with electromechanical systems and cleanroom manufacturing environments .

• Solid understanding of FDA , ISO 13485 , and GMP quality and regulatory requirements.

• Proven ability to manage multiple design projects, coordinate with cross-functional teams, and meet tight deadlines.

• Excellent documentation, communication, and stakeholder management skills.

• Experience supporting fixture validation and qualification protocols.

• Knowledge of automation or semi-automated fixture integration.

• Strong analytical and problem-solving skills with an attention to detail.

• Ability to collaborate effectively across onsite and offshore teams.

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