Mechanical Engineer

Job Title:  Mechanical Engineer

Location:  Andover, MA (In-person)

Company Overview

Digital Health Solutions (DHS) is a premier consulting firm dedicated to helping medical device companies navigate complex regulatory, engineering, and product development challenges. We specialize in guiding clients through IEC 62304 and ISO 13485 compliance, supporting them in delivering innovative, safe, and effective medical technologies to market.

Position Overview

We are seeking a Mechanical Engineer with 2 years of industry experience in product design, prototyping, or testing. This is a highly hands-on role that offers exposure to a wide range of engineering activities including mechanical design, fabrication, prototyping, electro-mechanical testing, and manufacturing support.

You will have the opportunity to work on a diverse range of medical technologies, including handheld diagnostic devices, point-of-care testing systems, wearable health monitors, and remote patient monitoring platforms. Projects often integrate mechanical, electrical, firmware, and software systems offering broad exposure to the full product lifecycle from early concept to production.

The ideal candidate thrives on variety, enjoys solving open-ended technical problems, and works comfortably both independently and in collaborative, cross-functional teams.

Key Responsibilities

• Design and model components and assemblies using SolidWorks CAD software.
• Build and test prototypes using in-house tools and fabrication techniques (e.g., 3D printing, hand-tools, assembly).
• Plan and perform mechanical and electrical tests, collect data, and prepare detailed technical reports.
• Support product development across mechanical, electrical, and system-level disciplines.
• Contribute to manufacturing readiness, including DFM/DFA review and supplier coordination.
• Participate in design reviews, verification and validation efforts, and continuous improvement initiatives.
• Collaborate closely with senior engineers to translate concepts into manufacturable designs.

Preferred Qualifications

• Bachelor’s or Master’s degree in Mechanical Engineering or related field.
• 2+ years of hands-on engineering experience in product design, R&D, or manufacturing.
• Interest in medical device development and regulatory processes
• Proficiency in SolidWorks (part and assembly modeling, drawings, and tolerancing).
• Strong hands-on skills with prototyping tools, fixtures, and instrumentation.
• Familiarity with mechanical testing, data acquisition, or basic electronics.
• Excellent problem-solving, communication, and documentation skills.
• Detail-oriented with a strong sense of ownership and initiative.
• Bonus: Experience with electrical design, PCBA integration, sensors, automation, embedded systems, or mechatronic integration.

Bonus Qualifications:

• Experience with IEC 60601 standards or other medical device regulatory frameworks.
• Knowledge of Quality Systems (ISO 13485, FDA QSR) and related documentation practices.
• Proficiency in GD&T (Geometric Dimensioning and Tolerancing) for precise mechanical design and inspection.
• Exposure to sensors, automation, or embedded hardware integration

What You'll Gain

·        Competitive salary and benefits package, including health insurance, 401(k) plan with employer match, vision, dental and paid time off.

• Mentorship from industry experts in engineering, regulatory affairs, and quality systems
• Exposure to all stages of the product lifecycle from concept through production.
• Practical experience with FDA regulations, ISO standards, and product development lifecycles
• A collaborative and fast-paced environment where innovation and creativity are valued.