Pay Rate Low: 110000 | Pay Rate High: 135000
 

Process Development Engineer

Location: Near Clark, NJ
Industry: Medical Device Manufacturing
Salary Range: $110,000 – $135,000 annually (commensurate with experience)

Position Overview

A growing medical device manufacturer near Clark, NJ is adding a Process Development Engineer to support the launch of new manufacturing capabilities.

This engineer will play a key role in developing and optimizing manufacturing processes, creating programs and SOPs, and ensuring successful transition into production. The role requires strong technical ownership, vendor collaboration, and internal project leadership within a highly regulated manufacturing environment.

This position is ideal for a hands-on, self-starting engineer who enjoys building processes from the ground up and working closely with operations, quality, and external equipment partners.

Key Responsibilities

• Lead development and implementation of manufacturing processes for new and existing products.

• Develop programs, procedures, and SOPs for new equipment, including a recently installed needle grinding machine.

• Collaborate with cross-functional teams to develop robust manufacturing and inspection methods.

• Oversee process development projects from concept through production handoff.

• Work directly with external vendors and equipment suppliers on setup, optimization, and troubleshooting.

• Communicate project timelines, risks, and requirements across engineering, operations, and leadership teams.

• Partner with manufacturing and quality engineers to ensure smooth process transfer into production.

• Lead or support process qualification and validation activities, including:

  • First Article Inspections

  • OQ / PQ validations

  • PFMEA

  • Control Plans

  • Measurement System Analysis (MSA)

  • PPAP activities as required

• Conduct process characterization and statistical analysis to improve quality, efficiency, and cost performance.

• Provide ongoing production support and drive continuous improvement initiatives.

• Manage multiple projects while meeting budget and timeline expectations.

• Support vendor audits or customer collaboration efforts as needed.

• Perform other duties as assigned.

Qualifications

• Bachelor’s degree in Engineering or related technical field.

• 7–15 years of process or manufacturing engineering experience.

• Strong process development and internal project management experience.

• Excellent communication, analytical, and organizational skills.

• Ability to manage multiple priorities in a fast-paced environment.

• High attention to detail and commitment to quality.

• Self-starter capable of working independently.

Preferred Experience

• Medical device or other highly regulated manufacturing experience.

• Contract manufacturing experience.

• Experience working with custom CNC or automated manufacturing equipment.

• Experience collaborating with external vendors on equipment/process development.

• Experience supporting capital equipment implementation and qualification.
  
  INDBH