Mechanical Engineer

Keypoint Staffing; Boston (MA); On-site; USD 110,000 - 160,000; Full time

Job summary

Keypoint Staffing seeks a Mechanical Engineer for a growing medical device organization on a full-time, on-site basis in the Boston area. You will design assemblies, create SolidWorks models, and support verification across the product development lifecycle from concept through manufacturing readiness.

The role requires a Bachelor’s in Mechanical Engineering, 5+ years of design experience, and familiarity with FDA QSR/ISO 13485.

Qualifications

• Bachelor's degree in Mechanical Engineering or related discipline required.
• 5+ years of product design and development experience.
• Proficiency in SolidWorks CAD software.
• Experience leading or contributing to new product development programs.
• Knowledge of manufacturing processes incl. injection molding, metal forming, welding, and mechanical assembly.
• Experience designing for manufacturability and automation.
• Working knowledge of FDA QSR and ISO 13485 Design Controls.
• Strong project management, organizational, and problem-solving capabilities.
• Proficiency with Microsoft Office and Microsoft Project.
• Excellent written and verbal communication skills.
• Ability to work independently and manage multiple priorities in a fast-paced environment.

Responsibilities

• Design and develop mechanical components, subsystems, and complete medical device assemblies.
• Create and maintain 3D models, drawings, and specs in SolidWorks.
• Plan, execute, and document characterization, verification, and environmental testing.
• Develop test protocols and generate test reports for validation.
• Collaborate with suppliers to source, evaluate, and qualify components and processes.
• Partner with operations and quality to ensure manufacturability and compliance.
• Translate requirements into engineering deliverables and milestones.
• Participate in cross-functional design reviews and technical discussions.
• Prepare and maintain development documentation per regulatory and quality requirements.
• Identify and mitigate risks related to performance, reliability, safety, cost, and scalability.
• Support continuous improvement of design and manufacturing processes.

Skills

Project management

Communication

Problem-solving

Independent work

Cross-functional collaboration

Design optimization

Education

Bachelor's in Mechanical Engineering

Master's in Engineering (preferred)

Tools

SolidWorks

Microsoft Office

Microsoft Project

Job description

Job Description

Position OverviewA growing medical device organization is seeking a skilled mechanical engineer to support the design, development, testing, and optimization of innovative medical device products. This role is fully onsite and collaborative in nature, working cross-functionally with engineering, quality, operations, supply chain, and leadership teams across the full product development lifecycle — from early concept and prototyping through validation and manufacturing readiness.

Key Responsibilities

• Design and develop mechanical components, subsystems, and complete medical device assemblies
• Create and maintain detailed 3D models, engineering drawings, and product specifications using SolidWorks
• Plan, execute, and document characterization, verification, and environmental testing activities
• Develop test protocols and generate comprehensive test reports in support of product validation
• Collaborate with suppliers to source, evaluate, and qualify components, tooling, and manufacturing processes
• Partner with operations and quality teams to ensure products meet design and manufacturability requirements
• Translate customer and project requirements into engineering solutions and deliverable milestones
• Participate in cross-functional design reviews and technical discussions to identify and resolve design challenges
• Prepare and maintain product development documentation in compliance with customer, regulatory, and quality requirements
• Identify and mitigate risks related to product performance, reliability, safety, cost, and scalability
• Support continuous improvement efforts related to product design, manufacturing processes, and engineering best practices

Qualifications

• Required:
• Bachelor's degree in Mechanical Engineering or a related engineering discipline
• 5+ years of product design and development experience
• Proficiency in SolidWorks CAD software
• Experience leading or contributing to new product development programs
• Knowledge of manufacturing processes including injection molding, metal forming, welding, and mechanical assembly
• Experience designing products for manufacturability and automation
• Working knowledge of FDA Quality System Regulations (QSR) and ISO 13485 Design Controls
• Strong project management, organizational, and problem-solving capabilities
• Proficiency in Microsoft Office and Microsoft Project
• Excellent written and verbal communication skills
• Ability to work independently and manage multiple priorities in a fast-paced environment

Preferred

• Master's degree in Engineering or a related field
• 7+ years of medical device engineering experience
• Experience working within FDA-regulated and ISO 13485-certified manufacturing environments
• SolidWorks Expert Design Certification
• Background in electro-mechanical systems, instrumentation, robotics, or automation technologies

Work Environment & Schedule

• Professional office, laboratory, and cleanroom setting
• Collaborative, team-oriented culture with broad cross-functional exposure
• Business casual dress code
• Standard hours: Monday – Friday, 8:00 AM – 5:00 PM
• Full-time onsite attendance required
• Occasional travel to customer sites may be needed
• No direct supervisory responsibilities; project-level guidance may be provided as needed

Physical Requirements

• Ability to work at a computer for extended periods
• Full wrist, hand, and finger dexterity required for engineering and laboratory tasks
• Comfortable working in engineering lab and cleanroom environments

Equal Opportunity Statement

This employer is committed to building a diverse and inclusive workplace. All qualified applicants will be considered without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, veteran status, or any other characteristic protected under applicable federal, state, or local law.