Process Development Engineer III

Industry

Engineering

Advert ID

FOX_BBBH34653

Location

Fridley

Job Type

Permanent

Hours

Full-Time

Salary Range

USD90000.00-105000 per year

No. of Openings

1

Branch Information

Minnesota Engineering - (USA) 3600 Minnesota Drive Suite 850 MN Edina , MN 55435 Phone : 612-630-1200

ContactNumber

612-630-1200

Job Description

Process Development Engineer III | Fridley, MN | Direct Hire | Medical Device Industry | $90-$105k + 10% Bonus









* 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 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.

* 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.



Qualifications









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

* A minimum of 5 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 own 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)

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Wire Grinding development (grind a profile into a wire used for guidewire)- OD Grinding, centerless grinding (Strongly preferred)