Sr. Project Engineer - Advanced Injection Molding

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: silicone and thermoplastic molding.
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.
We are currently hiring for a Sr. Project Engineer - Advanced Injection Molding who is:
o 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.
o 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 not required).
o Responsible to execute new Injection Molding programs cost-estimating and team feasibility reviews for activities in support of quoting and launching new business opportunities through cross-functional teams
o Self-motivated and thrives in a fast -paced, cutting-edge, "lean" systems environment, where priorities can often change on a daily basis.
Basic Responsibilities
o Responsible for On-Time Completion, Quality, and Cost Targets associated with the Implementation of New Injection Molds into Production and assigned CIP Projects
o Interfaces with customers and suppliers on project matters, mold and fixture design, validation, product quality issues, and executes on automation related projects
o Coordinates the Process Validation of both Thermoplastic and Silicone Injection Molds working with Process Engineering/Quality - responsible for Final Validation of Product
o Coordinates Scientific Injection Molding is utilized in process development
o Responsible for ensuring Design for Manufacturability - advises customers on required mold/part design changes
o Prepares complete and accurate records of assigned project activities per the established Quality System and Validation Guidelines
o Creates Procedures, Work Instructions and Protocols as required
o Creates/Coordinates Engineering Change Notices for all New and Existing Products
o 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. No surprises.
o Conducts regular project meetings with customers and internally, publishes timely project updates, and follows-up continuously on all open critical path items
o Generates and maintains documentation for all internal processes, inspection criteria, Bill of Materials, Validation Protocols/Reports and other manufacturing and quality records
o Conceptualizes and develops lean manufacturing processes for new and existing business opportunities, which may include new and/or modified plant, equipment and process needs
o Coordinates the Process Validation of New Molds working with Process Engineering/Quality - responsible for Final Validation of Product
o Coordinates Tooling Build (NOT Part Design) working with both external and internal Injection Mold Makers to ensure an optimized injection molding process can be achieved.
o Improves productivity and reduces scrap/reject rates through automation, tool/process improvements, effective training of production personnel and process enhancements
Required Qualifications
o Bachelor's degree in a related technical field such as Mechanical Engineering or Plastics Engineering
o Minimum 5-10 years working as a Tooling/Process/Project engineer in Injection Molding along with demonstrated project management skills managing engineering projects
o Working knowledge of engineering terminology and technical experience with injection molding of thermoplastics, processes, tooling and validation protocols.
o Strong customer/supplier/vendor communication and follow-up skills
o Exceptional attention to detail
o Metric driven - proven success in meeting project completion dates and cost targets vitally important in an extremely dynamic environment
o Ability to manage risks and make business decisions
o Technical experience in injection molding of thermoplastics related to Design for Manufacturability of Molds and Processing of thermoplastics
o Experience with automation and assembly of components
o Previous experience in a manufacturing environment of medical or healthcare products
o Demonstrated oral and written communication skills, and presentation skills
o Familiarity with statistical problem solving techniques
o Working knowledge of Validation (IQ/OQ/PQ)
Preferred Qualifications:
o Silicone injection molding
o CAD experience in 2D dimensioning and tolerancing and Solid Works
o Strong business and economic acumen
It's 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;job_pub_nr=6C4B4659-CB72-4ECC-BE59-F9BD966BCBFD;p=homepage_com;job_pub_type=extern
Helix Medical is an Equal Employment Opportunity Employer.

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