Process Development Engineer

• Design and execute Design of Experiments (DOE) to characterize and optimize manufacturing processes for improved yield and efficiency.
• Lead and manage projects involving new production equipment, process improvements, and cost reduction initiatives in support of new product introductions.
• Conduct equipment qualifications (IQ/OQ/PQ) and process validations.
• Apply Lean manufacturing principles and root cause analysis tools (e.g., DMAIC) to improve product quality, labor efficiency, and throughput.
• Coach and mentor technicians, trainers, and operators on process improvements and best practices.
• Coordinate the design, procurement, fabrication, installation, and debugging of tooling, machinery, and test equipment.
• Collaborate cross-functionally with R&D, Quality, Finance, and Operations to define and improve process inputs and outputs.
• Ensure compliance with FDA regulations, company policies, and applicable Quality Management System (QMS) and Environmental Management System (EMS) requirements.
• Support divisional and company-wide initiatives as directed by management.
• Maintain effective communication and collaboration with internal teams, customers, contractors, and vendors.
• Strong ability to work independently and within cross-functional teams in a matrixed environment.
• Excellent written and verbal communication skills.
• Strong organizational skills with high attention to detail and ability to prioritize multiple tasks.
• Results-driven mindset with strong analytical and problem-solving capabilities.
• Proven project management and multitasking abilities.

Bachelor of Science degree in Engineering or a related technical discipline, or an equivalent combination of education and relevant work experience.

• Establish and develop manufacturing processes based on product specifications and Design for Manufacturability (DFM) principles.
• Evaluate process and design alternatives with consideration for Cost of Goods Sold (COGS).
• Ensure program compliance with Quality Control requirements, including Design Control and Process Validation.
• Maintain awareness of intellectual property considerations related to developed processes.
• Stay current with emerging manufacturing and design technologies.
• Ensure compliance with workplace safety and environmental regulations (e.g., OSHA).
• Support Quality, Environmental, and regulatory initiatives in alignment with company standards and FDA requirements.

• Bachelor’s degree in Chemical, Industrial, Mechanical Engineering, or a related discipline.
• Minimum of 5 years of manufacturing engineering experience in the medical device or a related regulated industry.
• Demonstrated experience in process improvement and documentation.
• Strong communication skills with the ability to interact effectively at all organizational levels.
• Experience working in a matrixed and geographically diverse business environment.
• Strong analytical, problem-solving, and project management skills.
• Highly organized with strong follow-through and attention to detail.
• Ability to work independently with minimal supervision.
• Proficiency with Microsoft Office applications (Word, Excel, Outlook, PowerPoint).

• Prior experience in the medical device industry.
• Lean Six Sigma Green Belt or Black Belt certification.