Senior Engineer - New Product Development (NPD)

Location: Northern NJ (Onsite, 5 days per week)

Industry: Medical Device Manufacturing

Job Description

We are looking for a Senior Engineer to lead New Product Development (NPD) and process engineering efforts for cutting-edge medical devices. This is a leadership role where you will drive the design and implementation of manufacturing processes, oversee quality control initiatives, and mentor junior engineers. You will be responsible for overseeing the PPAP process, implementing inspection methods like CMM and blue light scanning, and ensuring compliance with industry standards.

Key Responsibilities

• Lead New Product Introduction (NPD) projects from concept through to manufacturing, ensuring timely and cost-effective launches.
• Spearhead the development and improvement of manufacturing processes, incorporating advanced inspection methods (CMM, blue light scanning).
• Own the PPAP (Production Part Approval Process), ensuring all parts and processes meet rigorous industry standards.
• Apply Geometric Dimensioning & Tolerancing (G&D&T) principles in product design and manufacturing to ensure precision and compliance.
• Collaborate with R&D, production, quality assurance, and regulatory teams to optimize product designs and processes.
• Mentor and guide entry-level and mid-level engineers, fostering a culture of continuous improvement.
• Drive innovation and problem-solving in manufacturing processes, ensuring products meet safety and regulatory requirements.
  
  

Qualifications

• Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, Industrial Engineering, or a related field.
• 5 years of experience in New Product Development and/or medical device manufacturing.
• Advanced experience with manufacturing processes, CMM, blue light scanning, and PPAP.
• In-depth understanding of Geometric Dimensioning & Tolerancing (G&D&T) principles.
• Proven track record in managing complex NPD projects and leading cross-functional teams.
• Strong leadership, communication, and organizational skills with a strategic mindset.
• Experience with FDA regulations, ISO standards, and quality assurance practices in the medical device industry.
  
  

Work Environment: As a Senior Engineer, you will be responsible for overseeing multiple projects and teams. This role is for highly experienced individuals who are passionate about driving innovation and leading teams to success in the medical device industry.