Engineer I - Entry Level

Engineer I - Entry Level
Medical Components, Inc., in Harleysville, PA

Full-Time & Onsite – only accepting resumes from the local or surrounding area within a reasonable commute to be onsite every day.
Industry: Medical Devices

Work Authorization:
Candidates must be legally authorized to work in the United States without the need for current or future sponsorship. This role is not eligible for visa sponsorship.

About Us
Medical Components, Inc., (Medcomp) is a leading innovator in the medical device industry, committed to improving patient outcomes through advanced technology and high-quality products.

Position Summary
This entry-level engineering role, that will collaborate closely with the Engineering team members to support the design, development, and launch of disposable medical devices from concept through commercialization.  This role contributes to product development, process validation, and manufacturing transfer, ensuring compliance with all design control standards and regulatory requirements.

Key Responsibilities

• Assist in the implementation of new products and processes into manufacturing
• Support the design and development of tooling and fixtures for product inspection and assembly
• Contribute to maintaining compliance with quality systems and regulatory standards
• Assist in developing and implementing quality policies and procedures
• Collect, track, and analyze product data (yield, output, efficiency)
• Partner with Manufacturing/Production Engineers to troubleshoot and resolve issues
• Support root cause analysis for product failures and returns
• Assist in creating Bills of Materials (BOMs) and manufacturing routers
• Follow established design control procedures for product development
• Participate in validation activities and testing requirements
• Prepare and review engineering documentation
• Contribute to feasibility studies and ROI analyses for capital projects
• Attend project and team meetings
• Travel as needed

Required Qualifications

• Bachelor’s degree in Engineering, Mechanical Engineering, Biomedical Engineering, or a related discipline.
• 1–2 years of relevant experience, preferably in the medical device industry
• Experience with product design, validation, or manufacturing processes

Preferred Qualifications

• Master’s degree or professional certifications
• Knowledge of Six Sigma and Lean Manufacturing principles
• Experience with molding and tooling
• Familiarity with FDA regulations, ISO 13485 standards, ASTM, GMP, MDR/MDD requirements
• Internship or co-op experience in medical device industry.

Technical Skills

• Proficiency in Microsoft Office applications
• Experience with CAD software (SolidWorks preferred)
• Familiarity with ERP systems (e.g., MAPICS, NetLink) and databases (FileMaker Pro)
• Understanding of engineering drawings, specifications, and drafting principles
• Knowledge of statistical and analytical techniques

Core Competencies
Successful candidates will demonstrate:

• Strong problem-solving and analytical skills
• Effective written and verbal communication
• Ability to work collaboratively in a team environment
• Attention to detail and commitment to quality
• Adaptability in a fast-paced, dynamic environment
• Professionalism, integrity, and accountability

What We Offer

• Competitive salary
• Comprehensive benefits
  • Medical, Dental, Vision, & FSA
  • Generous PTO
  • Paid Holidays
  • 401(k)
• Opportunities for professional growth and development
• Collaborative and inclusive work environment
• Meaningful work that impacts lives around the world