Process Engineer

Date: Jun 25, 2022

Location: Dorado, US, 00646-4802

Company: Heraeus

[title]
Process Engineer
Location Dorado
Permanent  
Full Time
 

Together we improve lives. At Heraeus Medical Components, we leverage our breadth of expertise in material science, leading-edge technologies, and supply chain excellence to build sustainable and successful partnerships with medical device OEMs. As a result, the work we do is felt and trusted by our partners and the patients who rely on them for life-saving and life-changing medical devices.

As a global company with 10 locations worldwide, we are committed to the growth of our teams and sites. Our vision is to improve 100 million lives each year, and to accomplish our vision, we have built a culture of curiosity that thrives on challenge, continuous learning, and the opportunity to take risks and try new things. Good ideas are celebrated here, so join us as we act boldly, think openly, work thoughtfully, and with our partners, improve patient lives worldwide.

Heraeus Medical Components is part of the Heraeus Group, a FORTUNE Global 500 listed portfolio company. The group’s roots go back to a family pharmacy started in 1660. Today, the Heraeus group includes businesses in the environmental, electronics, health and industrial applications sectors. Heraeus is one of the top 10 family-owned companies in Germany and holds a leading position in its global markets.

 
 

Main tasks and Responsibilities:

  • Leads validation and qualification activities for processes and equipment using Heraeus processes.
  • Develops, documents, coordinates and executes: User requirements specifications (URS), Factory Acceptance Test (FAT), Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualifications (PQ's) and Process Validations (PV).
  • Leads project management activities related to New Product Introductions (NPI) and Change Control activities.
  • Work closely with the commercial team in determining feasibility for new products and processes. Initiate and coordinates changes to the ERP system (SAP) including new/updated routings, material changes, labor determination, among others.   
  • Develops and writes adequate standards operations procedures (SOP's) and work instructions (WI's) for different manufacturing activities.
  • Recommends and implements new automated, semi-automated equipment and fixturing/tooling to improve operations. 
  • Develop Capex justification for new or improves equipment.
  • Recommends a spare parts program for all equipment.
  • Assess & establish adequate equipment/tool maintenance activities and complete Machine Risk Assessment. 
  • Maintains manufacturing equipment records of current, transfer and/or new purchases.
  • Recommends and implements manufacturing layouts in collaboration with CI Engineer.
  • Designs or suggests adequate utilities installation.
  • Conducts trainings to operators and technicians as required. Completes certification activities.
  • Develops expertise in the Manufacturing processes to improve efficiencies and coordinates and execute process improvements activities.
  • Prepares purchase order request of parts, materials or services related to engineering activities.
  • Performs CAPA investigations and executes corrective and preventive actions as per Heraeus procedures.
  • Support investigations about nonconformance events and approve disposition decisions. 
  • Leads or assists with Risk Management process and/or process FMEA activities.
  • Follows and supports the Heraeus' quality system, policies and objectives.

 

Qualifications:

Bachelor's Degree in  Engineering (Mechanical or Electrical is preferred) or Master's in science (MS) in Engineering.
Good verbal and writing communication skills, Bilingual (English/Spanish).
Technical Knowledge: Good Manufacturing Practices knowledge, General Electrical Power Systems, Programmable Logic Controller (PLC), General Pneumatic Systems, and General Hydraulic knowledge, Statistical Process Control (SPC), Design of Experiments (DOE), General Lean Manufacturing concepts, Technical writing, General validation knowledge.

Experienced in medical device industry or pharmaceutical industry is preferred.
Knowledge in ERP systems (SAP) is preferred.