Lead Mechanical Engineer

Motion Recruitment Partners LLC; Boston (MA); On-site; USD 100,000 - 150,000; Full time

Job summary

A leading medical device company seeks a Lead Mechanical Engineer to spearhead the design and development of innovative diagnostic instruments. This critical role entails collaboration with diverse teams, ensuring robust product creation in a dynamic environment focused on improving patient outcomes. Candidates with extensive experience in the medical device industry and a passion for cutting-edge technology are strongly encouraged to apply.

Qualifications

• 7+ years of experience in the medical device industry, focusing on product development.
• Proven track record leading mechanical design projects from concept to launch.
• Strong background in diagnostic instruments, disposable components, or fluidics systems.

Responsibilities

• Lead the design and development of diagnostic instruments and consumables.
• Collaborate with cross-functional teams to ensure product integration.
• Drive design reviews, FMEA processes, and ensure compliance with regulatory standards.

Skills

Collaboration

Leadership

Communication

Education

Bachelor’s or Master’s degree in Mechanical Engineering

Tools

3D CAD software (Creo)

SolidWorks

Job description

Our client, an innovativediagnostic 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.