Engineer Ii

**Process Development Engineer II**

**Summary**

Hands-on engineer responsible for providing expertise in developing manufacturing processes for electrophysiology catheters, and similar products. Demonstrates competence in medical device and manufacturing environment. Support and own processes from development through production including process development, capability, and quality deliverables, as well as process cost and technology improvements. Understands process characterization tools and uses them as needed across various technologies.

**Essential Duties and Responsibilities**
- Contribute to process design, development, validation activities through product life cycle for interventional device products in accordance to project scope
- Assess and provide input for product design for manufacturing.
- Develops processes, fixtures, and equipment for project requirements.
- Utilizes process characterization skills and tools such as Design of Experiments (DOE), pFMEA, scale up factors, mitigation to foreseen risks, and capability analysis. This knowledge may be leveraged across various technologies as needed.
- Ensure that proper technology processes are developed, implemented, maintained, and documented to successfully introduce new products into manufacturing.
- Involved in prototyping, process development, confirmation runs, and validation. Available to support and trouble shoot production issues as needed.
- Assume responsibility for completeness and accuracy of developed processes (i.e., lead, manage, communicate, complete documentation, train) including ownership of process capability, process quality and controls, and process costs.
- Work with development and production operators and technicians on new and revised processes.
- Assist in and lead new equipment identification, procurement, installation qualification, document creation, and training. May participate in execution of these activities as needed.
- Coordinate new tooling/fixturing identification, procurement, and verification. Will participate in execution of these activities as needed.
- Identify new technologies in accordance with site and customer priorities to improve efficiency, quality, reduce costs, and meet market technology needs.
- Provide training to others based on expertise or demonstrated work performance.
- Assist in part review at quote or PO stage based on project need and process knowledge.
- Support business line and project engineering with accurate communication and representation of HMC’s capabilities.
- Works with a positive attitude and acts within the principles of the HMC Core Values. Adheres to the Heraeus Code of Conduct Policy as applicable for position.
- Performs other duties as assigned by manager or the company.

**Qualifications**
- Bachelor’s Degree in Engineering (Mechanical, Biomedical) or related technical field required.
- A minimum of 4 years engineering experience within medical device development or manufacturing environment
- Familiarity with cGMP/GLP/GDP guidelines, ISO 13485, 21 CFR part 820, etc.
- Demonstrated strong technical writing skills to support and drive process and qualification documentation required
- Experience with guidewires or catheter manufacturing processes preferred (Wire grinding, profiler, inspection equipment, and CNC machining are desired)
- Demonstrated experience of process development, capability, optimization, and validation. Application of statistical and analytical methods such as DOE highly desired.
- Experience with troubleshooting, maintenance, and repair of manufacturing equipment.
- CAD/CAM experience or training; SolidWorks highly desired or equivalent job experience.
- Must possess proficient written and oral communication skills and ability to utilize MS Office suite tools
- Previous experience in document control and SAP preferred
- Ability and willingness to travel internationally to support process, product, and equipment transfers is highly preferred (5% - 15% travel)
- Proficiency in reading, writing, and speaking English. Must be able to clearly articulate and listen attentively to questions, concerns and feedback from coworkers and customers. Must be able to create legible, accurate, and detailed documents that clearly communicate product and manufacturing expectations
- Highly motivated hands-on engineer with the ability to work independently and as part of a cross-functional team