Principal R&D Engineer (Process Development)

Position Overview

We are seeking an experienced Principal R&D Engineer to support the development, validation, and commercialization of manufacturing processes for innovative medical devices. This role will focus on process development, statistical analysis, process validation, and cross-functional collaboration to ensure safe, high-quality, and compliant manufacturing solutions.

The ideal candidate will have experience in regulated medical device manufacturing, scientific problem-solving, and process characterization while working closely with engineering, quality, operations, and project teams.

Key Responsibilities

• Develop, optimize, and validate manufacturing processes for medical device products.
• Design and execute process characterization studies, Design of Experiments (DOE), and process validation activities.
• Perform IQ, OQ, PQ, TMV, PCR, and MSA studies to ensure manufacturing readiness and regulatory compliance.
• Apply statistical methods to analyze data, evaluate process capability, and support data-driven decision making.
• Lead technical investigations, identify root causes, and implement corrective actions.
• Collaborate with cross-functional teams including R&D, Manufacturing, Quality, Regulatory, and Operations.
• Support establishment and continuous improvement of manufacturing lines while balancing safety, quality, delivery, and cost.
• Develop project plans, manage risks, communicate project progress, and ensure milestones are achieved.
• Read, understand, and follow Quality Management System (QMS) procedures and documentation.
• Utilize scientific problem-solving methodologies such as:
  • DMAIC
  • Process Mapping
  • 5 Whys
  • 6M Analysis
  • Timeline Analysis
  • Is/Is Not Analysis
• Analyze technical data using laboratory analytical techniques and instrumentation including:
  • HPLC
  • LC-MS
  • Mass Spectrometry (MS)
  • FTIR
• Support research activities and translate scientific discoveries into manufacturable products.
• Provide technical leadership and mentor junior engineers when required.

Required Qualifications

• Advanced Degree in one of the following:
  • Physics
  • Mechanical Engineering
  • Biomedical Engineering
  • Materials Science
  • Chemistry
  • Chemical Engineering
  • Or a related engineering discipline
• Minimum 5 years of relevant experience with an advanced degree.

Top 3 Required Technical Skills

1. Process Development, Characterization, and Validation (DOE, PCR, TMV, IQ, OQ, PQ)
2. Strong Statistical Analysis skills
3. Excellent Scientific Problem-Solving abilities

Required Technical Skills

• Medical device manufacturing and process development
• Process characterization
• Process validation
• Design of Experiments (DOE)
• Statistical analysis
• MSA (Measurement System Analysis)
• IQ/OQ/PQ validation
• TMV (Test Method Validation)
• PCR (Process Characterization Report)
• Scientific problem-solving methodologies
• Quality Management Systems (QMS)
• Cross-functional collaboration
• Project planning and basic project management
• Risk management
• Data analysis and interpretation
• HPLC
• LC-MS
• Mass Spectrometry (MS)
• FTIR
• Independent technical leadership
• Regulatory compliance

Preferred Qualifications

• Root cause investigation and failure analysis
• Technical writing
• Strong organizational and communication skills
• Computer Software Validation (CSV)
• Lean Six Sigma methodologies
• DFSS (Design for Six Sigma)
• DRM methodologies
• Green Belt or Black Belt Certification
• Excellent teamwork and collaboration skills