Fixture Design Engineer

Position : Fixture Design Engineer

Location : Draper, Utah (Onsite)

Contract Duration : 12+ months

Experience : 5+ years

Eligibility : US Citizens, Green Card Holders, H4EAD, TN, or L2

Job Overview :

We are seeking a skilled Fixture Design Engineer with expertise in assembly fixture development for medical devices. The ideal candidate will have hands-on experience designing, developing, and validating fixtures used in the manufacturing and testing of electromechanical medical systems. This role requires strong knowledge of precision engineering, medical device regulations, and cross-functional collaboration. The engineer will act as the primary point of contact for fixture design, coordinating with manufacturing engineers, gathering requirements, and delivering design outputs while supporting validation activities.

Key Responsibilities :

Develop assembly fixture concepts, including concept drawings and tolerance stack-up analysis.

Create detailed CAD designs, 2D drawings, and prepare submissions for design release.

Coordinate with manufacturing engineers to collect necessary data and deliver design outputs.

Collaborate with offshore teams to review and finalize fixture designs.

Support fixture qualification activities (TFIQ), including completing validation reports in the required formats.

Manage project schedules, planning, and adherence to timelines.

Qualifications :

Bachelor's or Master's degree in Mechanical Engineering, Biomedical Engineering, or a related field.

5+ years of experience in medical device engineering, with at least 3 years focused on fixture design.

Proficient in CAD software (SolidWorks or Creo).

Solid understanding of GD&T, tolerance stack-up analysis, and material selection.

Knowledge of regulatory standards including FDA, ISO 13485, and GMP.

Experience working with electromechanical systems, cleanroom environments, and validation protocols.