Process Development Engineer II

Job Description

Job DescriptionSummary:

Executes plans for major process related segments of complex product development projects. Compiles and analyzes process performance data to establish process design and specifications for newly designed or modified products. Plans and validates equipment and processes of newly designed products to internal and external requirements. Executes process development related activities on project.

Essential Duties and Responsibilities (but are not limited to):

• Lead the design, development, characterization, and validation of manufacturing processes for new product development.
• Collaborate closely with R&D teams, customers, and leadership to define process specifications and performance requirements.
• Plan, organize, and coordinate technical activities to transition products from concept to final realization.
• Execute key deliverables to advance processes from feasibility through production launch.
• Advocate for Design for Manufacturability (DFM) during early development phases to ensure robust and scalable product designs.
• Identify and implement suitable manufacturing processes and equipment to optimize product manufacturability.
• Oversee the manufacturing processes of both new and existing products, ensuring efficiency, scalability, and quality.
• Develop innovative solutions to complex engineering challenges by revising standard technical principles and methodologies.
• Prepare project plans, specifications, resource allocations, and schedules for new product development initiatives.
• Collaborate with engineers, technicians, contract manufacturers, and assemblers to support prototype manufacturing, process development, and validation activities.
• Define critical process parameters and develop comprehensive validation plans, including IQ (Installation Qualification), OQ (Operational Qualification), PQ (Performance Qualification), and external service validations.
• Identify process inputs and outputs, establishing effective monitoring and control strategies.
• Define and track key process performance metrics (yield, capacity, capability, efficiency) to ensure successful production transfer.
• Provide technical guidance and mentorship to technicians and junior engineers.
• Establish and optimize new and existing processes to meet product design and performance criteria.

• Evaluate process alternatives for manufacturability, assessing yield and throughput impacts.
• Work within cross-functional teams to address quality issues and facilitate process transfer to full-scale manufacturing.
• Lead process validation efforts, including equipment qualification and process optimization (IQ/OQ/PQ).
• Train operators on new and existing manufacturing processes.
• Conduct troubleshooting, validation, and continuous process improvements to enhance efficiency and product quality.
• Collaborate with internal and external vendors to design tooling and fixtures for manufacturing.
• Develop and implement Control Plans to ensure process consistency and compliance.
• Take full responsibility for the accuracy and completeness of developed manufacturing processes.
• Serve as a key contributor or leader on cross-functional project teams.

Education/Experience:

• Recommended 2+ years engineering experience in a regulated manufacturing environment.
• Bachelors Degree in engineering or equivalent.