Lead Mechanical Engineer

Our client, an innovative diagnostic medical device company, is seeking a Lead Mechanical Engineer to join their team. This individual will play a critical role in leading the design, development, and refinement of mechanical systems for next-generation diagnostic products. The company is committed to transforming point-of-care diagnostics and is looking for someone who thrives in a collaborative, fast-paced environment.

This is an excellent opportunity for an experienced mechanical engineer who is passionate about improving patient outcomes through cutting-edge technology.

Key Responsibilities

• Lead the mechanical design and development of diagnostic instruments and consumables from concept through commercialization.

• Collaborate closely with cross-functional teams including electrical engineering, software, biology, manufacturing, and quality to ensure product integration and performance.

• Provide technical mentorship and leadership to junior mechanical engineers and designers.

• Execute detailed mechanical design using CAD tools (e.g., SolidWorks), including modeling, drawing creation, and tolerance analysis.

• Drive design reviews, FMEA processes, and risk assessments to ensure robust product development.

• Oversee prototype builds, testing, and iterations to refine product performance and manufacturability.

• Support transfer to manufacturing and scale-up, including vendor engagement and design-for-manufacturing (DFM) improvements.

• Ensure compliance with FDA, ISO, and other applicable regulatory standards for medical device development.

Qualifications

• Bachelor’s or Master’s degree in Mechanical Engineering or related field.

• 7+ years of experience in the medical device industry, with a strong focus on product development and commercialization.

• Proven experience leading mechanical design projects from concept through launch.

• Strong background in the development of diagnostic instruments, disposable components, or fluidics systems is highly desirable.

• Proficient in 3D CAD software (Creo) and design documentation practices.

• Experience with design verification and validation (V&V), DFM, and GD&T.

• Familiarity with quality systems (ISO 13485), risk management (ISO 14971), and regulatory requirements for Class II or Class III devices is a plus.

• Excellent communication skills and the ability to work collaboratively in a team-oriented environment.