Process Development Engineer II- Electrophysiology

Heraeus Medevio

Location Cartago

Permanent

Full Time

 

 

Job Purpuse

This role will be a part of a cross functional team to ensure completion of the project according to project schedule and budget.   As part of the process development team, you will be responsible for creating robust and sustainable manufacturing processes for medical components and devices. As Engineer II you will provide the technical leadership for the commercial release of products to production by working cross-functionally through the Medevio product development process.

Major responsibilities

Key process owner for processes for new product development and transfer projects according to project schedule and in compliance with applicable regulations and Quality Systems.

• Participates in the execution of the process design, development, and validation activities for medical devices through the product development process.
• Uses process characterization skills and tools such as Design on Experiments (DOE), pFMEA, DFM, and statistics to make data driven decisions.
• Creates or leverages documents such as process validation demonstrate technical rationale for associated decision.
• Demonstrates consistent understanding in determine solutions for complex problems, process selection decisions, and technical challenges.
• Willing and able to mentor other engineers and promotes a culture of feedback.

Knowledge, skills and abilities

Education     

• Bachelor’s degree in an Engineering discipline or related technical field.

Knowledge and skills

• Knowledge in process development (medical catheter processes preferred).
• Able to make data driven decisions utilizing statistics.
• Experienced with process validation, installation qualification, and finished engineering deliverables from the product development process.
• Proven competence in completing projects according to established scope, budget, and timelines.
• Able to communicate technical concepts to all audiences including senior management, production employees, and customers.
• Able to identify, execute, and communicate on any technical and/or project workstreams.
• Excellent analytical and problem-solving skills.
• Demonstrated ability to develop cross-functional relationships and influence to drive results.
• Demonstrates strong leadership in communicating and championing the need for continuous improvements and continued change to meet company needs. 
• Fluent in spoken and written business English and Spanish.

Experience   

• 2-4 years of relevant work experience required, including previous experience in the medical device industry.
• Transfer Process Projects implementation.

License or certification required

• Six sigma green/yellow belt.