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Design Engineer MN Open (J#19113)
Education: Bachelors Degree
Experience: 4 - 9 years

Our well-respected and growing Medical Device client in St. Paul is seeking a qualified individual to fulfill a Product Desinger/Engineer role. Job duties are as follows:

Product Design/Re-design: Help develop product concepts following specific Design Control procedures per ISO and FDA utilizing processes such as DOE and FMEA, amongst others
Perform Risk Analysis
Define Test Protocols and Acceptance Criteria
Prepare/Review drawings for engineering, production and quality control as requested
Prepare/Review prototype drawings as requested
Prepare/Review drawings of existing product to document product specifications as requested
Direct necessary changes to improve drawing completeness
Define manufacturing protocols, materials and specifications
Design/Develop Fixtures to aid in assembly and production
Assist with Quality control of products before shipping
Assist Quality Assurance Manager to comprehend quality related issues and to be involved on resolution team
Maintain drawings within the Device Master Record (DMR)
Maintain Drawing Access System for CAD Files
Revise drawings using the Document Change Request (DCR) process
Create formal process documentation such as Work Instructions (WI), Inspection Procedures (IP), Manufacturing Procedures (MP)
Institute and document operating procedures
Create and maintain records and files that comply with GMP and ISO Requirements such as Device Master Record (DMR), Device History File (DHF), Design History Record (DHR) and Technical Construction Files (TCF)
Pay DOQ

Please view candidate qualifications to see if you have the right experience for this role. You will be joining a winning team that cares about their employees professional development. Please forward all resumes to: AmyR@mpsstaffing.com

Requirements:

Qualified Candidates MUST POSSESS THE FOLLOWING SKILL SET:

Minimum of 4 year technical degree (BS/ME preferred) or similar work experience
Knowledge of manufacturing assembly, Quality Assurance, machine shop, plastics, metals, materials
Knowledge of DOE, FMEA and Risk Management processes
Knowledge of Microsoft Office at an Intermediate or higher level
Knowledge of Trigonometry, Geometry and Algebra
Knowledge of ISO 13485 or 9001
5+ years work experience as a Product Designer utilizing Design Control Procedures with Medical Devices (in an ISO 13485 or ISO 9001 certified company) required
5+ years Project Management experience with Medical Devices required
3+ years experience with AutoCAD 2000 or higher
4+ years experience with Solid Works
Blue Print reading ability, ability to figure out auxiliary views, multi-view sketching or drawing
Metrology - ability to use calipers, micrometers, gauge pins and optical comparator

MPS Staffing is the Specialist in the Medical Device Industry offering opportunities to top talent in the areas of Assembly, Skilled Industrial, Engineering, Quality Assurance, Inside/Outside Sales, Medical Billing and Administrative Support. If you're a professional in the MedTech industry and are serious about your career call us today!
 
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