Product Development Engineer II – Medical Devices

Enovis Corporation; Austin, Northern (TX, KY); Hybrid; USD 85,000 - 110,000; Full time

Job summary

Enovis Corporation in Austin, TX is seeking a Product Development Engineer II to design, test, and contribute to development activities for medical device products. You will interface with physicians and customers, create prototypes, document results, and coordinate multiple projects with the R&D team.

The role involves detailed design work, DHF documentation, and helping with 510(k) submissions while ensuring quality and regulatory compliance across mechanical and electronic components.

Qualifications

• Bachelor's degree in engineering or related field.
• 2+ years of professional experience (1 year with a Masters).
• Proficiency with MS Word, Excel and Project is required.
• Experience with 3D CAD packages, SolidWorks preferred.

Responsibilities

• Participate in product development from concept through production, including prototyping and testing.
• Create detailed designs and documentation (risk assessments, V&V plans/reports, DHRs).
• Develop engineering drawings using 3D CAD (SolidWorks).
• Collaborate with cross-functional teams (Manufacturing, Quality, Marketing, Regulatory).
• Assist with Design History File maintenance and FDA submission support.

Skills

MS Word

Excel

Project

Education

Bachelor's degree in engineering

Tools

SolidWorks

Job description

Enovis Corporation in Austin, TX is seeking a Product Development Engineer II to design, test, and contribute to development activities for medical device products. You will interface with physicians and customers, create prototypes, document results, and coordinate multiple projects with the R&D team.

The role involves detailed design work, DHF documentation, and helping with 510(k) submissions while ensuring quality and regulatory compliance across mechanical and electronic components.