Process Development Engineer I

Job Description:

Essential Duties and Responsibilities

Under the guidance of a Staff or Senior Staff Process Development Engineer:

• Function as a competent engineer in conventional aspects of process development, technical problem solving, and engineering assignments.

• Support process development activities from proof-of-concept prototypes through manufacturing validation and production implementation.

• Plan, coordinate, and execute engineering activities, studies, and programs supporting both existing products and new product development initiatives.

• Participate in process development and implementation activities across diverse engineering disciplines.

• Evaluate products, equipment, tooling, and process capabilities to support development and manufacturing objectives.

• Provide equipment recommendations and tooling modifications to support process improvements and optimization initiatives.

• Investigate and resolve process-related issues through data analysis, root cause identification, and implementation of corrective actions.

• Execute in-process testing and product release testing activities.

• Collaborate with operators, technicians, manufacturing teams, and engineers to deliver products that meet customer and quality requirements.

• Coordinate manufacturing and training activities associated with engineering builds, including:

  • Biocompatibility Builds

  • Design Verification Builds

  • Operational Qualification (OQ) Builds

  • Performance Qualification (PQ) Builds

• Provide technical guidance and coordinate activities of engineers, technicians, drafters, and other support personnel when required.

• Independently perform most assignments while working toward established project objectives and deliverables.

• Promote and comply with company safety, quality, and regulatory policies and procedures.

• Perform manufacturing reviews and pre-validation assessments to ensure the successful implementation of new processes.

• Maintain accurate documentation in accordance with engineering best practices, company procedures, and regulatory requirements.

• Prepare technical reports and engineering documentation with minimal supervision.

• Conduct engineering experiments, process characterizations, and Design of Experiments (DOE) activities.

• Record test procedures, collect and analyze data, and document results in technical reports and engineering records.

• Set up, adjust, and operate R&D laboratory and manufacturing equipment.

• Support project execution through hands-on activities in manufacturing, engineering, validation, and process development environments.

Education and Experience

• Bachelor's Degree in Engineering or a related technical discipline.

• 8 months to 1.5 years of experience in a similar engineering role.

• Medical device industry experience is highly desirable.

• Experience supporting process development, validation, characterization, or manufacturing engineering activities is desirable.

Other Skills and Abilities

Required

• Advanced English proficiency is a must.

• Microsoft Office proficiency, including Excel.

• Statistical knowledge and data analysis fundamentals.

• Ability to interpret technical and mechanical drawings.

• Strong organizational and project coordination skills.

• Strong hands-on approach and ability to work in manufacturing environments.

Desirable

• Minitab knowledge.

• Workfront knowledge.

• SolidWorks knowledge.

• Experience with:

  • Design of Experiments (DOE)

  • Process Characterization

  • Installation Qualification (IQ)

  • Operational Qualification (OQ)

  • Performance Qualification (PQ)

Work Environment

• Manufacturing and engineering environment.

• Frequent interaction with production personnel, technicians, engineers, and cross-functional teams.

• Significant hands-on involvement in development, validation, and manufacturing activities.

Comments

This job description outlines the primary responsibilities of the role and is not intended to be all-inclusive. Additional assignments and responsibilities may be required based on business needs and project priorities.