Director Engineering – Medical Plastic Devices

FPC (FORTUNE PERSONNEL CONSULTANTS - Orlando Office); Newark (NJ); Hybrid; USD 180,000 - 240,000; Full time

Benefits offered by this job

Relocation assistance

Job summary

Fortune Personnel Consultants is seeking a Director of Engineering for a medical plastics group. The role focuses on plastics and polymers used in extrusion, injection molding, forming, and assembly of medical device components.

The candidate will own technology strategy, collaborate with sales, and lead cross‑functional teams in the US and EU, with significant travel and a 40% onsite requirement. Relocation support is offered.

Qualifications

• Engineering experience with plastics & polymer materials used in medical devices.
• Hands-on experience with medical device products via extrusion, molding, forming or assembly.
• Familiarity with ISO 13485 and regulatory quality requirements.
• Prior customer-facing experience in applications engineering or technical sales.
• Proven ability to lead and develop technical teams, including multi-site or international teams.
• Strong understanding of plastics part production and assemblies.

Responsibilities

• Lead and manage Engineering teams in the US and EU.
• Collaborate with sales to map customer needs to solutions and offerings.
• Own technical strategy and roadmap in alignment with commercial goals.
• Drive development and introduction of new features and solutions.
• Partner with customers to provide technical guidance and engineered solutions.
• Measure success by product line growth and feature/benefit improvements.
• Ensure processes align with ISO 13485 and FDA requirements.

Skills

Plastics & polymers

Medical devices

Customer-facing

Leadership

Regulatory compliance

ISO 13485

FDA process knowledge

Multisite teams

Communication

Education

Bachelor's degree in Engineering or Materials Science

Job description

Director Engineering - Medical Plastic Devices

A multi-billion-dollar global manufacturer of medical devices and components is seeking a Director of Engineering for its Plastics / Polymers Group.

This hands-on role centers on medical device products and components manufactured from plastics and polymers through extrusion, forming, injection molding, and assembly. The role combines technical strategy ownership, customer-facing solution development, and close partnership with sales and commercial teams.

Key Responsibilities

• Lead and manage Engineering teams in the US and EU.
• Collaborate with sales teams to identify customer needs and match them to solutions, features, and offerings.
• Own technical strategy and roadmap development in alignment with commercial and sales teams to deliver customer solutions and grow product offerings for medical device components.
• Drive the development and introduction of new product features, benefits, and solutions that expand existing product lines and create new revenue opportunities.
• Partner with customers (medical device OEMs and contract manufacturers) to provide applications support, technical guidance, and engineered solutions.
• Measure success through growth in product lines, expansion of product features, introduction of new solutions and offerings, and quantified feature/benefit improvements.
• Ensure solutions and processes align with medical device industry requirements, including ISO 13485 quality management standards.

Required Qualifications

• Engineering experience (products made from plastics & polymer materials and related finished products experience).
• Hands-on experience with medical (device) products and components produced via extrusion, injection molding, forming, or assembly.
• Hands-on experience with medical device industry products and familiarity with regulatory/quality requirements, including ISO 13485.
• Prior customer-facing experience in an applications engineering, technical sales, or similar role.
• Proven ability to lead and develop technical teams (experience managing multi-site or international teams is highly desirable).
• Strong understanding of plastics parts production processes, injection molded and plastic extruded parts and assemblies.
• Excellent communication and collaboration skills to work effectively with sales, product management, and customers.
• Bachelor’s Degree in Engineering or Materials Science.
• This role requires onsite presence approximately 40% of the time, with the balance hybrid. Travel is expected at 35-40% and includes both domestic and international trips.
• Company provides relocation assistance.

Ideal candidates bring medical device product experience with plastics processing (extrusion, injection molding, assembly), in medical applications combined with engineering leadership, including customer-facing solution support, and technical roadmap ownership developed with sales and new business development along with understanding of quality ISO 13485 including FDA approval process.

This position is located near Phillipsburg, NJ zip code: 08865