Mechanical Engineer (Contract)
Digital Health Solutions, Andover, MA, United States
Overview
Job Title:
Mechanical Engineer – 6-Month Contract
Location:
Andover, MA (In-person)
Company:
Digital Health Solutions
Contract Type:
6-Month Contract | Opportunity to Convert to Full-Time
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.
Role Description
We are seeking an experienced Mechanical Engineer to join our team on a 6-month contract basis, with the opportunity for conversion to a full-time position based on performance and business needs. This is a highly hands-on role for a seasoned engineer who thrives on building, testing, and iterating on complex medical device hardware.
You will contribute to a diverse portfolio of medical technologies—including handheld diagnostic devices, point-of-care testing systems, wearable health monitors, and remote patient monitoring platforms. Projects span the full product lifecycle from early concept through production, integrating mechanical, electrical, firmware, and software systems.
The ideal candidate brings 4+ years of medical device development experience, is equally comfortable in CAD and in the lab, and can work effectively across cross-functional teams.
Key Responsibilities
Lead mechanical design and modeling of components and assemblies using SolidWorks, including part modeling, assemblies, engineering drawings, and GD&T.
Drive hands-on prototyping activities using in-house tools including 3D printers, hand tools, and standard lab fabrication equipment.
Perform design for injection molding (DFM/DFI) analysis and collaborate with suppliers to optimize designs for manufacturability and cost.
Support electrical circuit debugging and electro-mechanical integration, working alongside electrical engineers on PCBA and sensor integration.
Plan and execute mechanical and electro-mechanical tests; collect and analyze data; author detailed technical reports and test protocols.
Contribute to design for manufacturing and assembly (DFM/DFA) reviews and support supplier qualification and coordination.
Participate in design reviews, verification and validation (V&V) efforts, and risk management activities in compliance with ISO 13485 and IEC 60601 standards.
Maintain and contribute to design history files (DHF), device master records (DMR), and related regulatory documentation.
Collaborate closely with cross-functional teams including electrical, software, and quality engineers to translate concepts into manufacturable, compliant designs.
Required Qualifications
Bachelor’s or Master’s degree in Mechanical Engineering or a closely related field.
3+ years of hands-on engineering experience in medical device product development or R&D.
Proficiency in SolidWorks, including part and assembly modeling, engineering drawings, and tolerancing.
Demonstrated experience with hands-on prototyping techniques including 3D printing, bench fabrication, and custom fixturing.
Experience with design for injection molding (DFM/DFI), including working knowledge of tooling considerations, draft angles, wall thickness, and parting lines.
Ability to support electrical circuit debugging and work effectively in an electro-mechanical development environment.
Strong technical writing skills for test protocols, engineering reports, and design documentation.
Excellent problem-solving, communication, and cross-functional collaboration skills.
Detail-oriented with a strong sense of ownership and initiative in a fast-paced project environment.
Preferred Qualifications
Experience with IEC 60601, ISO 14971, or other medical device regulatory and safety standards.
Knowledge of Quality Management Systems (ISO 13485, FDA 21 CFR Part 820) and associated documentation practices.
Proficiency in GD&T (Geometric Dimensioning and Tolerancing) for design and inspection.
Experience with sensors, wearables, embedded hardware, or mechatronic system integration.
Familiarity with design history files (DHF), device master records (DMR), and regulatory submission support.
Exposure to automation, data acquisition systems, or test fixture design.
What You\'ll Gain
Competitive contract compensation with the opportunity to convert to a full-time position.
Mentorship from industry experts in engineering, regulatory affairs, and quality systems.
Exposure to all stages of the product lifecycle across multiple medical device platforms.
Practical experience with FDA regulations, ISO standards, and medical device product development lifecycles.
A collaborative, fast-paced environment where hands-on innovation and technical excellence are valued.
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Job Title:
Mechanical Engineer – 6-Month Contract
Location:
Andover, MA (In-person)
Company:
Digital Health Solutions
Contract Type:
6-Month Contract | Opportunity to Convert to Full-Time
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.
Role Description
We are seeking an experienced Mechanical Engineer to join our team on a 6-month contract basis, with the opportunity for conversion to a full-time position based on performance and business needs. This is a highly hands-on role for a seasoned engineer who thrives on building, testing, and iterating on complex medical device hardware.
You will contribute to a diverse portfolio of medical technologies—including handheld diagnostic devices, point-of-care testing systems, wearable health monitors, and remote patient monitoring platforms. Projects span the full product lifecycle from early concept through production, integrating mechanical, electrical, firmware, and software systems.
The ideal candidate brings 4+ years of medical device development experience, is equally comfortable in CAD and in the lab, and can work effectively across cross-functional teams.
Key Responsibilities
Lead mechanical design and modeling of components and assemblies using SolidWorks, including part modeling, assemblies, engineering drawings, and GD&T.
Drive hands-on prototyping activities using in-house tools including 3D printers, hand tools, and standard lab fabrication equipment.
Perform design for injection molding (DFM/DFI) analysis and collaborate with suppliers to optimize designs for manufacturability and cost.
Support electrical circuit debugging and electro-mechanical integration, working alongside electrical engineers on PCBA and sensor integration.
Plan and execute mechanical and electro-mechanical tests; collect and analyze data; author detailed technical reports and test protocols.
Contribute to design for manufacturing and assembly (DFM/DFA) reviews and support supplier qualification and coordination.
Participate in design reviews, verification and validation (V&V) efforts, and risk management activities in compliance with ISO 13485 and IEC 60601 standards.
Maintain and contribute to design history files (DHF), device master records (DMR), and related regulatory documentation.
Collaborate closely with cross-functional teams including electrical, software, and quality engineers to translate concepts into manufacturable, compliant designs.
Required Qualifications
Bachelor’s or Master’s degree in Mechanical Engineering or a closely related field.
3+ years of hands-on engineering experience in medical device product development or R&D.
Proficiency in SolidWorks, including part and assembly modeling, engineering drawings, and tolerancing.
Demonstrated experience with hands-on prototyping techniques including 3D printing, bench fabrication, and custom fixturing.
Experience with design for injection molding (DFM/DFI), including working knowledge of tooling considerations, draft angles, wall thickness, and parting lines.
Ability to support electrical circuit debugging and work effectively in an electro-mechanical development environment.
Strong technical writing skills for test protocols, engineering reports, and design documentation.
Excellent problem-solving, communication, and cross-functional collaboration skills.
Detail-oriented with a strong sense of ownership and initiative in a fast-paced project environment.
Preferred Qualifications
Experience with IEC 60601, ISO 14971, or other medical device regulatory and safety standards.
Knowledge of Quality Management Systems (ISO 13485, FDA 21 CFR Part 820) and associated documentation practices.
Proficiency in GD&T (Geometric Dimensioning and Tolerancing) for design and inspection.
Experience with sensors, wearables, embedded hardware, or mechatronic system integration.
Familiarity with design history files (DHF), device master records (DMR), and regulatory submission support.
Exposure to automation, data acquisition systems, or test fixture design.
What You\'ll Gain
Competitive contract compensation with the opportunity to convert to a full-time position.
Mentorship from industry experts in engineering, regulatory affairs, and quality systems.
Exposure to all stages of the product lifecycle across multiple medical device platforms.
Practical experience with FDA regulations, ISO standards, and medical device product development lifecycles.
A collaborative, fast-paced environment where hands-on innovation and technical excellence are valued.
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