Mechanical Engineer

Role Overview:

We are seeking an experienced Mechanical Engineer to support product development and qualification activities for the A15 and A17 monitors. The role involves creation of new parts, assemblies, and drawings, as well as supporting development of single-use Lead Wire Adapters and Flex adapters, including sourcing alternate components for existing designs.

The position requires hands-on CAD expertise, documentation rigor, and experience operating within a regulated medical device environment.

Key Responsibilities:

·         Create and update parts, assemblies, and engineering drawings using On-Shape.

·         Support qualification activities for new A15 and A17 monitor designs.

·         Assist in development of single-use Lead Wire Adapters and Flex adapters, including evaluation of alternate components.

·         Develop and maintain packaging and labeling artifacts in compliance with regulatory requirements.

·         Create and execute test plans, analyze results, and prepare detailed reports.

·         Participate in design reviews, risk assessments, and change control processes.

·         Collaborate with Electrical, Firmware, Software, QA, RA, and Manufacturing teams.

·         Support design verification, validation, and release to manufacturing.

Education & Experience Required:

·         Bachelor's degree in Mechanical Engineering.

·         5–10 years of experience in mechanical product development, preferably in medical devices or regulated industries.

·         Strong hands-on experience with On-Shape CAD (part, assembly, and drawing creation).

·         Experience supporting design qualification and verification activities.

·         Familiarity with packaging, labeling, and documentation requirements in regulated environments.

·         Experience with component sourcing and design updates related to obsolescence or alternate part qualification.

Required Skills & Competencies:

·         Strong understanding of mechanical design principles and DFM (Design for Manufacturing).

·         Experience with materials selection, tolerance analysis, and assembly design.

·         Ability to create and execute structured test plans and generate technical reports.

·         Familiarity with design control processes and change management systems.

·         Strong analytical, documentation, and problem-solving skills.

·         Effective collaboration in cross-functional environments.