Job Duties Principal Manufacturing Engineer, Capital for Monteris Medical Corporation dba Monteris Medical. Provide engineering support for the development and manufacture of capital hardware devices that interact with disposables and software. Responsible for creation & execution of process validations, master validation qualification plans, test method validations, cost savings proposals, risk analysis (PFMEA), diagnosis/problem solving via root cause analysis, and operational control improvements. Responsible for manufacturing procedure development, process improvements and product diagnosis and repair. Identify, propose, and execute continuous improvement projects. Provide regular technical support to Operations/Supply Chain, Quality, and Service to ensure business success and productivity. Plan, support, and own design transfer activities by developing manufacturing processes and validation plans, executing process risk assessments and associated process validations. Actively seeks out partnerships with manufacturing personnel to improve process flow and part manufacturability. Understand and follow internal quality system, FDA, and ISO requirements. Identify, improve and validate test methods used in a production setting. Assist in identification of requirements and methods of acquiring requirements with a focus on reliability and design for manufacture. Represent engineering on cross-functional teams for manufacturing to improve current product and new product design. Assist Supply Chain/Operations and Quality Engineering departments in the identification, sourcing, and procurement of materials and products. Support development testing as needed. Develop and implement processes to improve manufacturing and refurbishment processes commonly executed within manufacturing engineering. Develop and qualify tooling and manufacturing aids to improve manufacturability of existing and new products. Provide refurbishment instructions for product that has been returned from the field. Work closely with Service Team to resolve field issues related to hardware or software issues. Role is located in Minnetonka, Minnesota and requires on-site presence to provide direct support to production. Perform other duties as directed or assigned.

Minimum Education Required Requires at least a Bachelor's degree in Biomedical Engineering, Manufacturing Engineering or related Engineering field and at least five years of progressively responsible, post baccalaureate experience as a manufacturing or quality engineer in medical device manufacturing/process development. In lieu of a Bachelor's plus five years of experience as described above, a Master's degree in Biomedical Engineering, Manufacturing Engineering or related Engineering field and at least three years of experience as a manufacturing or quality engineer in medical device manufacturing/process development is acceptable. Any suitable combination of education, training and/or experience is acceptable.

Minimum Experience Required Must have 3 years of exp with each of the following:

Coordinating cross-functionally with Engineering, Quality, Operations, and Field Service teams.
Statistical analysis tools such as Minitab.
FDA regulations surrounding the manufacture of medical devices, GMPs and process validations.
Developing and improving manufacturing processes related to the build of electro-mechanical systems.
Development and qualification of equipment used in production.
Support of Quality System Audits by regulatory bodies.
Risk based decision making within Medical Device Industry.

The following Certification is required:
Green Belt Certified at the time of application.
ISO 13485 Lead Auditor Certification

The position is located at Monteris Medical Corporation, 131 Cheshire Lane Suite 100, Minnetonka, MN 55305.

For confidential consideration, please submit resume via email: careers@monteris.com. No agencies or phone calls please.

Shift First (Day)

Number of Openings 1

Compensation $124,467.00 / Annually

Postal Code 55305

Place of Work

On-site

Requisition ID

9755

Job Type

Full Time

Job Benefits

n/a

Application Email

careers@monteris.com

Monteris Medical

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Principal Manufacturing Engineer, Capital