Process Development Engineer

Job 2786 Process Development Engineer - Contract located near Phoenix, Arizona

Medical Engineering Consultants (MEC) support medical device and pharmaceutical companies to be more efficient and productive by providing resources, knowledge, and expertise to augment and supplement to their work. Our vision is to closely align our clients’ needs with the best resources available in the marketplace. We take proactive, preventative, and corrective action and create a roadmap for ongoing future improvement by identifying, integrating, and executing sustainable solutions that validate processes, ensure fully compliant quality systems, and close gaps between current and FDA expected stages.

MEC offers companies short or long-term support — from high-end leaders, managers and consultants to skill-set Engineering staff and SME’s (Subject Matter Experts).

MEC's mission is to inspire positive cultural change from within, and always exceed our clients’ expectations.

Applicants must be authorized to work in the U.S. in accordance with applicable law. This position is not eligible for employer-sponsored work authorization now or in the future.

Onsite

Position Summary

Our client is seeking a highly skilled Senior R&D Process Development Specialist to support the development, characterization, validation, and optimization of advanced medical device manufacturing processes.

This role will serve as a technical expert responsible for process development activities, leading complex projects from concept through implementation while collaborating with cross-functional stakeholders to deliver innovative and high-quality products.

The successful candidate will be a recognized subject matter expert with strong analytical, statistical, and problem-solving capabilities, capable of independently driving process improvements and validation strategies within a regulated environment.

Top Required Technical Skills

Process Development & Validation:

• Process characterization
• Design of Experiments (DOE)
• Process validation
• Installation Qualification (IQ)
• Operational Qualification (OQ)
• Performance Qualification (PQ)
• Technical Manufacturing Validation (TMV)
  
  

Statistical Analysis

• Experimental design and data analysis
• Statistical process evaluation
• Data-driven decision making
  
  

Advanced Problem Solving

• Root cause analysis
• Process troubleshooting
• Continuous improvement methodologies
  
  

Key Responsibilities

• Design, develop, analyze, troubleshoot, and provide technical expertise during research and product development activities.
• Lead process characterization and validation efforts to establish robust, scalable manufacturing processes.
• Design and execute studies to investigate critical technical and scientific questions.
• Apply statistical methods and DOE techniques to optimize process performance and product quality.
• Translate research findings into practical and commercially viable solutions.
• Drive resolution of complex technical issues through structured problem-solving methodologies.
• Develop and implement improvements to processes, systems, and products to enhance performance and reliability.
• Lead and manage complex technical projects, ensuring delivery of project objectives on schedule.
• Collaborate with cross-functional teams including R&D, Quality, Manufacturing, Regulatory, and Operations.
• Provide technical guidance, coaching, and mentorship to engineers and junior team members.
• Represent the organization as a technical lead for key projects, interacting with internal and external stakeholders as needed.
• Ensure compliance with applicable quality systems, regulatory requirements, and company procedures.
  
  

Education

Required Qualifications

Advanced degree (Master's or PhD preferred) in one of the following disciplines:

• Physics
• Mechanical Engineering
• Materials Science
• Chemistry
• Chemical Engineering
• Biomedical Engineering
• Or related technical/scientific field
  
  

Experience

• Minimum 5 years of relevant experience with an advanced degree.
• Experience in process development, characterization, and validation within a regulated industry.
• Demonstrated expertise applying DOE and statistical analysis tools.
• Strong background in technical problem solving and root cause investigations.
• Experience leading complex technical projects with minimal supervision.
• Knowledge of project management principles preferred.
  
  

Career Level

Specialist Career Stream

This role is intended for an experienced individual contributor recognized as a technical expert within their specialty. The position requires independent decision-making, leadership of major projects, and the ability to influence technical direction and business outcomes through specialized expertise.

Success Factors

The Ideal Candidate Will Demonstrate

• Deep technical expertise in process development and validation.
• Strong statistical and analytical capabilities.
• Ability to solve complex, ambiguous technical challenges.
• Excellent communication and stakeholder management skills.
• Proven leadership in cross-functional project environments.
• Ability to mentor and guide technical team members.
• A proactive mindset focused on innovation, quality, and continuous improvement.
  
  

MEC does not accept unsolicited resumes through or from search firms or staffing agencies. All unsolicited resumes will be considered the property of Medical Engineering Consultants (MEC) and will not be obligated to pay a placement fee.

• Sponsorship is not available for this position
  
  

Check us out at www.medicalengineeringconsultants.com

AAP/EEO DFWP

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Other Duties

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.