Senior Mechanical Engineer - Medical 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

Located in Fairfield County, we work with cutting-edge Swiss machining, laser cutting, and 5-axis milling technology to create precision components used in life-changing medical devices. If you're looking for a team-oriented environment where you can make an impact with every part you produce, we want to hear from you!

Position Overview

We are seeking a Senior Mechanical Engineer to lead mechanical design and product development for medical manufacturing projects. The role focuses on delivering robust, manufacturable products and automation solutions using CAD and SolidWorks, ensuring compliance with medical device standards, and guiding cross-functional teams from concept through production.

Key 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 risk assessments (e.g., DFMEA) 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.

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.

Benefits

• Competitive Salary $110,000 - $120,000
• Full Medical Insurance
• Short-Term Disability and Long-Term Disability
• Life Insurance
• Paid Vacation Days ( You deserve a break!!)
• Paid Holidays
• 401k