Mechanical Engineer II, Medical Device Development PathRight Medical - 5.0 Orem, UT Job Details Full-time $95,000 - $120,000 a year 23 hours ago Benefits Paid time off Qualifications Developing medical devices 3D modeling software Medical device testing GD&T 3D modeling for product design Bachelor's degree Medical device design Product design Design for manufacturability (DFM) Design controls Biomedical regulatory compliance Research & development Mechanical product validation projects Mechanical knowledge

ISO 13485

Full Job Description About PathRight Medical PathRight Medical designs, manufactures and sells medical devices for men's health, including the RestoreX penile traction system. We build and mold our devices in house in Utah and sell them in the US and international markets. We are a small company with a growing R D pipeline, so each engineer owns real design work from concept through manufacturing transfer. The role We are hiring a mid-level Mechanical Engineer to design and develop medical devices under design controls. You will own mechanical design work on new products and improvements to current products. You will work closely with quality, regulatory and manufacturing, and take designs from early prototypes to production. What you will do Design mechanical parts and assemblies for medical devices, from concept sketches to released drawings Build 3D CAD models and 2D drawings with correct GD&T, and run tolerance stack-up analysis Design plastic and metal parts for manufacture, including injection-molded parts, and work with molders and machine shops Build and test prototypes, and turn test results and user feedback into design changes Write and run design verification protocols and reports, and support design validation and usability work Create and maintain design history file content: design inputs, outputs, traceability and design reviews Take part in risk management to ISO 14971, including design FMEAs Support design transfer: specifications, inspection criteria, fixtures and supplier qualification Support engineering change orders and investigations for released products What you bring Bachelor's degree in mechanical engineering, biomedical engineering or a related field 3 or more years of mechanical design experience

Required:

2 or more years of hands-on medical device product development experience under design controls (FDA

QMSR, 21 CFR

820, and

ISO 13485

) Proficiency in SolidWorks or a similar 3D CAD tool Working knowledge of GD&T, tolerance analysis and design for manufacturing Experience writing verification test protocols and reports Clear written and verbal communication, and comfort working in a small team with low oversight Preferred Experience taking a device from concept through design transfer to production Experience with injection-molded plastic parts and mechanisms such as springs, ratchets or adjustable assemblies Experience with

ISO 14971

risk management and design FMEAs Experience with biocompatibility (ISO 10993) or sterilization considerations Experience with FEA, rapid prototyping or 3D printing Experience supporting FDA 510(k) or De Novo submissions Why join us Work on products that patients use at home every day Own your designs end to end, with direct access to the people who make decisions Grow with an R D team that is expanding

Job Type:

Full-time Pay:

$95,000.00 - $120,000.00 per year

Benefits:

Paid time off

Education:

Bachelor's (Required)

Experience:

medical device product development: 2 years (Required) mechanical design: 3 years (Required) Ability to

Commute:

Orem, UT 84057 (Required) Ability to

Relocate:

Orem, UT 84057: Relocate before starting work (Required)

Work Location:

In person