Process Development Engineer

Job 2786 Process Development Engineer - Contract

Location:

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 their work. Our vision is to closely align our clients’ needs with the best resources available in the marketplace, proactively create roadmaps for improvement, and ensure fully compliant quality systems.

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.

We are seeking a highly skilled Senior R&D Process Development Specialist to support the development, characterization, validation, and optimization of advanced medical device manufacturing processes. The role serves as a technical expert leading complex projects from concept through implementation while collaborating with cross‑functional stakeholders to deliver innovative, high‑quality products.

• 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.

• Advanced degree (Master’s or PhD preferred) in Physics, Mechanical Engineering, Materials Science, Chemistry, Chemical Engineering, Biomedical Engineering, or a related technical/scientific field.
• 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.

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

• 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.

AAP/EEO DFWP. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

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.