About the RoleWe are seeking an experienced
Process Development Engineer to support the development, validation, optimization, and implementation of manufacturing processes within a highly regulated manufacturing environment. The selected professional will collaborate with cross-functional teams to develop robust manufacturing processes, qualify equipment, generate technical documentation, and support new product introductions while ensuring compliance with FDA and quality system requirements.
This position is ideal for engineers who enjoy working in fast-paced manufacturing environments where technical problem solving, continuous improvement, and process innovation are critical to success.
Key Responsibilities- Lead and support equipment qualification activities including IQ, OQ, PQ, and Process Performance Qualification (PPQ).
- Develop validation protocols, reports, and Master Validation Plans.
- Design and implement in-process and receiving inspection systems for new products and manufacturing processes.
- Prepare technical documentation including:
- Equipment evaluations
- Preventive Maintenance (PM) procedures
- Calibration procedures
- Manufacturing work instructions
- Manage process development projects from concept through implementation.
- Partner with Manufacturing, Quality, Engineering, Automation, and Operations teams to ensure successful project execution.
- Apply engineering tools including:
- Design of Experiments (DOE)
- PFMEA
- Risk Analysis
- Root Cause Investigations
- Support process characterization, optimization, troubleshooting, and continuous improvement initiatives.
- Work with advanced manufacturing technologies including:
- Laser welding
- Heat bonding
- Injection molding
- Vision inspection systems
- Automated equipment (PLC, Servo Systems, Pneumatics, Sensors)
- Support New Product Introduction (NPI) and process scale-up activities.
- Ensure compliance with FDA regulations, GMP requirements, and company quality systems.
Minimum Qualifications- Bachelor's Degree in Mechanical Engineering or Electrical Engineering.
- 5-7 years of manufacturing or quality engineering experience within an FDA-regulated industry.
- Experience in Medical Devices, Pharmaceutical, Biotechnology, or Diagnostics manufacturing.
- Strong knowledge of:
- Equipment Qualification (IQ/OQ/PQ)
- Process Validation
- DOE
- PFMEA
- CAPA
- Root Cause Analysis
- Experience developing technical documentation and validation deliverables.
- Working knowledge of:
- 21 CFR Part 820
- GMP
- ISO 13485
- Experience supporting automated manufacturing equipment and production systems.
Preferred Qualifications- Experience supporting New Product Introduction (NPI).
- Experience with automated manufacturing technologies.
- Knowledge of tooling, fixtures, and test method development.
- Strong project management and technical leadership skills.
- Excellent communication and cross-functional collaboration abilities.
What We're Looking ForThe ideal candidate is:
- Analytical and detail-oriented
- Strong technical problem solver
- Self-driven and proactive
- Comfortable working with multidisciplinary teams
- Committed to quality and continuous improvement
- Able to manage multiple priorities in a fast-paced manufacturing environment
Quality CommitmentThe selected candidate will demonstrate a strong commitment to patient safety, product quality, regulatory compliance, and documentation excellence while supporting all applicable Quality System requirements.
