Job Details

ID #40920226
State Minnesota
City Minnetonka
Job type Permanent
Salary USD US$80000 - US$90000 per annum + competitive US80000 - US90000 per annum + competitive
Source Real Staffing
Showed 2022-05-15
Date 2022-05-15
Deadline 2022-07-14
Category Et cetera
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Manufacturing Engineer II

Minnesota, Minnetonka, 55345 Minnetonka USA

Vacancy expired!

Purpose and Scope This role is to provide engineering support for the development and manufacture of capital hardware devices that interact with disposables and software. Activities include 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. This role is responsible for manufacturing procedure development, process improvements and product diagnosis and repair.

Primary Organization Responsibilities Identifies, proposes, and executes continuous improvement projects. Provides regular technical support to Operations/Supply Chain, Quality, and Service to ensure business success and productivity. Plans, supports, and owns 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. Determines, builds/acquires, validates, and maintains manufacturing processes, bills of material, equipment and tooling. Understands and follows internal quality system, FDA, and ISO requirements. Identifies, improves and validates test methods used in a production setting. Assists in identification of requirements and methods of acquiring requirements with a focus on reliability and design for manufacture. Represents engineering on cross-functional teams for manufacturing to improve current product and new product design. Assists Supply Chain/Operations and Quality Engineering departments in the identification, sourcing, and procurement of materials and products. Supports development testing as needed. Performs other duties as directed or assigned. Hands on when drafting testing methods and or procedures for new equipment

Qualifications and Experience

Education/Experience Bachelor's degree in engineering or related field is required. 3-5 years of experience in medical device manufacturing/process development. Previous experience with continuous improvement to product lines and experience in new product improvement.

Skills/Abilities Possesses engineering and analytic skills, including being detail oriented, inquisitive and able to work with complex systems. Possesses strong communication skills and the ability to coordinate cross-functionally with Engineering, Quality, Operations, Clinical and Marketing. Experience with statistical analysis tools such as Minitab. General understanding of FDA regulations surrounding the manufacture of medical devices, GMPs and process validations. Experience using Six Sigma and Lean Manufacturing tools is a plus. Experience with electromechanical processes. Possesses the ability to be able to build product as required.

Employment Type Full-time

EOE Statement: Specialist Staffing Group is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

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