Senior Medical Device Electromechanical Engineer

Sage Product Development, Inc.; Foxborough (MA); On-site; USD 90,000 - 130,000; Full time

Job summary

Sage Product Development, LLC. specializes in fast, efficient medical device development from concept to market introduction under contract.

The team collaborates with startups and established companies to meet customer expectations and deliver compliant, well-documented designs. The ideal candidate brings diverse electromechanical design experience, proficiency with SolidWorks, hardware/software prototyping, and a proven ability to move products from concept to market while navigating

Qualifications

• Bachelor's degree in Mechanical, Electrical or Biomedical Engineering or equivalent is required.
• Some prior medical device product design and development experience is required.
• Experience in electrical and/or electromechanical medical device design and development is required.
• Demonstrated ability to bring products from concept to market.
• Proficiency with soldering, wiring systems and electrical assembly.
• Familiarity with FDA QSR and ISO 13,485 medical device regulations.
• Experience with ISO 60601, 61010, EMC and/or EMI testing and failure mitigation.

Responsibilities

• Manage product development projects. Prepare project plans with phases, tasks, durations, and costs; communicate status to Sage and clients.
• Generate project timing and expense estimates and prepare proposals for client companies.
• Design and develop medical devices (disposable and reusable), catheters, equipment, implants, and packaging from concept through market introduction, ensuring regulatory and manufacturing compliance.
• Interact with client companies in a professional manner and maintain two-way information flow.
• Generate innovative concepts for new medical device designs; lead brainstorming and concept evaluation sessions.
• Design and prototype electromechanical systems; program prototype microcontrollers; use SolidWorks for 3-D CAD models and drawings.
• Research and select electrical/electromechanical components; evaluate existing technology for projects.
• Collaborate with vendors to guide custom circuit board and software design; assemble prototype devices for testing.
• Conduct bench and animal feasibility studies; perform product verification and validation testing; develop protocols and report results.
• Conduct risk analyses; manage ISO 60601, ISO 61010, EMC/EMI testing with outside vendors; troubleshoot failures.
• Coordinate with outside suppliers to ensure timely delivery of supplies and services.
• Maintain Design History Files and ensure documentation meets client Quality Systems requirements.
• Prepare documentation release packages and approve change orders as required.
• Conduct and document Design Reviews and participate in Material Review Board activities.

Skills

Project management

Electrical design

Mechanical design

Soldering/Wiring

SolidWorks

FDA QSR knowledge

ISO 60601 knowledge

Team collaboration

Communication skills

Problem solving

Education

Bachelor's degree in Mechanical, Electrical or Biomedical Engineering or equivalent

Master’s degree in engineering, management or business (plus)

Tools

SolidWorks CAD

Arduino programming

Circuit board design

Job description

Sage Product Development, LLC. specializes in fast, efficient medical device development from concept to market introduction under contract.

The team collaborates with startups and established companies to meet customer expectations and deliver compliant, well-documented designs. The ideal candidate brings diverse electromechanical design experience, proficiency with SolidWorks, hardware/software prototyping, and a proven ability to move products from concept to market while navigating