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.