Senior Mechanical Engineer, Medical Device Manufacturing

CyberCoders, Inc.; Fairfield (CT); On-site; USD 110,000 - 120,000; Full time

Benefits offered by this job

Full Medical Insurance

Short-Term/Long-Term Disability

Life Insurance

401k with company match

Paid Vacation Days

Paid Holidays

Job summary

CyberCoders, Inc. is seeking a Senior Mechanical Engineer in Fairfield County to lead mechanical design for medical manufacturing projects.

You will drive concept-to-production, deliver robust, manufacturable systems, and design automation solutions using CAD and SolidWorks while meeting ISO 13485 and FDA requirements. You will mentor junior engineers, collaborate with cross-functional teams, perform DFMEA/Risk analyses, and manage multiple projects with strong attention to detail.

Qualifications

• Bachelor's or Master's degree in Mechanical Engineering or related discipline.
• 5+ years of hands-on mechanical design experience, preferably in medical manufacturing or similar.
• Proficiency with SolidWorks and CAD software; strong modeling, surfacing and drawing skills.
• Experience designing automation systems, fixtures, and tooling for production environments.
• Solid understanding of GD&T, tolerance analysis, and engineering best practices.
• Familiarity with medical device regulations and quality systems (ISO 13485, FDA 21 CFR) is strongly preferred.
• Experience with prototyping, testing, and design verification/validation processes.
• Strong problem-solving skills, attention to detail, and ability to manage multiple projects and priorities.
• Excellent communication and collaboration skills; experience mentoring and leading engineering teams.
• Willingness to support supplier visits and occasional travel as needed.

Responsibilities

• Lead mechanical design activities for medical device and manufacturing automation projects, from concept through production release.
• Create detailed CAD models, assemblies, and manufacturing drawings using SolidWorks and other CAD tools.
• Develop automation design solutions, including actuators, fixtures, sensors, and control interfaces to improve manufacturing efficiency and quality.
• Apply Design for Manufacturability (DFM) and Design for Assembly (DFA) principles to reduce cost and simplify production.
• Prepare and maintain engineering documentation, including specifications, bills of materials, and design verification/validation plans.
• Perform tolerance analysis, GD&T application, and DFMEA risk assessments to ensure product reliability and safety.
• Prototype, test, and iterate designs; collaborate with test engineers to define and execute verification protocols.
• Collaborate closely with manufacturing, quality, supply chain, and regulatory teams to support design transfer and supplier selection.
• Mentor junior engineers, provide technical guidance, and review design work to maintain engineering standards.
• Support regulatory submissions and design history files in compliance with ISO 13485 and FDA requirements where applicable.

Skills

SolidWorks proficiency

CAD software

GD&T/tolerance analysis

Design for manufacturability

Mentoring/leadership

Regulatory awareness (ISO 13485/FDA)

Problem-solving

Effective communication

Education

Bachelor's or Master's in Mechanical Engineering

Tools

SolidWorks

Job description

CyberCoders, Inc. is seeking a Senior Mechanical Engineer in Fairfield County to lead mechanical design for medical manufacturing projects.

You will drive concept-to-production, deliver robust, manufacturable systems, and design automation solutions using CAD and SolidWorks while meeting ISO 13485 and FDA requirements. You will mentor junior engineers, collaborate with cross-functional teams, perform DFMEA/Risk analyses, and manage multiple projects with strong attention to detail.