Process Development Engineer II (WBL, Hockin)

Industry

Engineering

Advert ID

FOX_BBBH40666

Location

St. Paul

Job Type

Permanent

Hours

Full-Time

Salary Range

USD75000-90000 per year

No. of Openings

1

Branch Information

Minnesota Engineering - (USA) 3600 Minnesota Drive Suite 850 MN Edina , MN 55435

ContactNumber

612-630-1200

Job Description

Process Development Engineer II | Direct Hire | Medical Device Industry | White Bear Lake, MN | $75-$90k + 10% Bonus



Responsibilities:





* Lead or 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 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.

* Responsible for 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.



Minimum Qualifications:





* Bachelor's Degree in Engineering (Mechanical, Biomedical) or related technical field required.

* A minimum of 2 years engineering experience within medical device development or manufacturing environment

* Demonstrated strong technical writing skills to own and drive process and qualification documentation required

* Demonstrated experience of process development, capability, optimization and validation. Application of statistical and analytical methods such as DOE highly desired.

* Experience in light automation design, build, and implementation desired (PLC build and program)

* CAD/CAM experience or training; SolidWorks highly desired or equivalent job experience.



* Strong SolidWorks experience in fixture design highly preferred



* Previous experience in document control and SAP preferred