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Project Engineer MA Open (J#26767)
Education: Bachelors Degree
Experience: 4 - 9 years

Helix Medical is making a world of difference... all around the world.
As a global leader in medical contract manufacturing we offer the following services for medical device, pharmaceutical and IVD clients worldwide: product design and development, silicone and thermoplastic molding and extrusion, complex catheter systems, assembly, packaging, and engineering services.

For nearly 30 years, medical device and healthcare companies around the world have looked to Helix Medical to make a difference as the custom manufacturer medical industry leaders can trust. We operate FDA-registered, ISO 13485 certified medical device facilities with Class 7 & 8 cleanrooms. Helix Medical maintains design and manufacturing centers in California, Indiana, Massachusetts, Minnesota, Costa Rica, Germany, Ireland, and China.

We are currently hiring for a Sr. Project Engineer who is:
*Hands-on in a dynamic small shop environment where everyone is challenged by rolling up their sleeves to develop and implement solutions for our customer.
*Able to communicate technical solutions to customers, suppliers and tooling vendors with a focus on customer service, including presentation skills and follow-up (Medical Device experience is not required).
*Responsible to execute new product launch programs, cost-estimating and team feasibility reviews for activities in support of quoting and launching new business opportunities through cross-functional teams
*Self-motivated and thrives in a fast paced, cutting-edge, lean systems environment, where priorities can often change on a daily basis.

Basic Responsibilities
*Responsible for On-Time Completion, Quality, and Cost Targets associated with the Implementation of New *Injection Molds into Production and assigned CIP Projects
*Coordinates the Design and Build of New Tooling working with both external and internal Injection Mold Makers
*Coordinates the Process Validation of both Thermoplastic and Silicone Injection Molds working with Process *Engineering/Quality responsible for Final Validation of Product
*Responsible for ensuring Design for Manufacturability advises customers on required part design changes
*Prepares complete and accurate records of assigned project activities per the established Quality System and Validation Guidelines
*Creates Procedures, Work Instructions and Protocols as required
*Creates/Coordinates Engineering Change Notices for all New and Existing Products
*Plans and organizes project time lines for assigned projects using established formalized Project *Management tools. Advises management of any cost/delivery related issues for assigned projects
*Conducts regular project meetings with customers and internally, publishes timely project updates, and follows-up continuously on all open critical path items
*Generates and maintains documentation for all internal processes, inspection criteria, Bill of Materials, Validation Protocols/Reports and other manufacturing and quality records
*Conceptualizes and develops lean manufacturing processes for new and existing business opportunities, which may include new and/or modified plant, equipment and process needs
*Coordinates the Process Validation of New Molds working with Process Engineering/Quality responsible for Final Validation of Product
*Interfaces with customers and suppliers on project matters, mold and fixture design, validation, product quality issues, and executes on automation related projects
*Identifies, initiates and implements projects to improve productivity and reduce scrap/reject rates through automation, effective training of production personnel and process enhancements

Required Qualifications
*Bachelors degree in a related technical field such as Mechanical Engineering or Plastics Engineering
*Minimum 5-10 years working as a Tooling/Process/Project engineer in injection molding along with demonstrated project management skills managing engineering projects
*Strong customer/supplier/vendor communication and follow-up skills
*Metric driven proven success in meeting project completion dates and cost targets
*Technical experience in injection molding of thermoplastics related to Design for Manufacturability of Molds and Processing of thermoplastics
*Experience with automation and assembly of components
*Previous experience in a manufacturing environment of medical or healthcare products
*Demonstrated oral and written communication skills, and presentation skills
*Familiarity with statistical problem solving techniques
*Working knowledge of Validation (IQ/OQ/PQ)
*Working knowledge of engineering terminology and technical experience with injection molding of thermoplastics, processes, tooling and validation protocols.

Preferred Qualifications:
*Silicone injection molding
*CAD experience in 2D dimensioning and tolerancing and Solid Works
*Strong business and economic acumen

Its an exciting time to work at Helix Medical. We know our ability to succeed depends upon the people we employ. Leading-edge technology, the highest standards, and outstanding people make Helix Medical the employer of choice in this industry. We offer a competitive salary plus a full range of benefits including medical, dental and vision insurance, as well as 401K Match. Learn more at www.helixmedical.com/careers.

To Apply:
Candidates meeting these qualifications should complete the online application: https://freudenberg-jobs.dvinci.de/cgi-bin/appl/selfservice.pl?action=startapp;lang=en;p=homepage_com;job_pub_nr=6C4B4659-CB72-4ECC-BE59-F9BD966BCBFD;portal_name=homepage_com

Helix Medical is an Equal Employment Opportunity Employer.
 
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