Sr. Process Engineer/Specialist Advanced Injection Molding

Company Name:
Helix Medical
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. Process Engineer/Specialist Advanced Injection Molding 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.
Providing troubleshooting skills and trains shop floor personnel in problem solving methodology (Medical Device experience not required).
Responsible to implement continuous improvement on the Production Floor and support the flawless launch of new products to production through the development, validation of new tools and processes
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 all New and Existing Injection Molding Processes/Equipment and related Efficiency, Uptime, and Scrap Metrics for 24/5 Operations
Identifies and initiates projects to improve productivity and reduce scrap/reject rates through the implementation of Process Control, Automation, or Tool Modifications
Trains production personnel on process enhancements and troubleshooting methodology
Supports Production Floor in identifying root cause, and corrective action implementation of daily Production Related issues across all three shifts
Maintains complete and accurate records of assigned project activities per the established Quality System.
Participates as a team member on assigned projects using established APQP Project Management tools - Advises management of any cost related issues for assigned projects makes recommendations to optimize mold/part design as required
Supports the Validation of all new products into Production by running DOEs, Process Capability Studies, Gauge R&R, Gate Seal-Off, and Material Viscosity Studies
Generates and maintains documentation for all internal processes, inspection criteria, Bill of Materials and other manufacturing and quality records
Interfaces with customers and suppliers on project matters as required
Aids with short- and long-term planning for capital expenditures relating to future production requirements; leads projects involving new capital implementation
Maintain a vigilance to identify new potential technologies for the company.
Conduct internal audits and assists with maintaining the Quality System to ISO-13485 standards.
Maintains adherence to company policies, safety/ergonomic standards, and good housekeeping practices
Ability to support Production and New Business needs on Off-Shift and Weekends as required
Required Qualifications
Bachelor of Science degree in Engineering, preferably Plastics Engineering or Technology with a minimum 5 years of experience working as an Injection Molding Process Engineer
High School Diploma with 20+ years of experience working as an Injection Molding Process Specialist
Scientific injection molding background
Technical experience in Injection Molding processes, material behavior and mold design for mold ability
Experience programming/troubleshooting/installing automation
Proven success at setting and achieving ambitious goals while having a sense of urgency with regard to key initiatives Exceptional follow-up skills and attention to detail needed
Experience writing procedures, work instructions, and other related documents
Previous experience in managing multiple projects simultaneously
Lead by example in performance and behavior
Demonstrated excellent oral, written and computer skills, and presentation skills Microsoft Office Suite competency (Excel, Word, Power Point)
Familiarity with statistical problem solving techniques
Working knowledge of validation (IQ/OQ/PQ)
Proven success at managing cost budget and achieving financial justification for Capital Purchases
Previous experience working in a small manufacturing environment
Preferred Qualifications:
Experience with Injection Molding of silicone
Previous experience in a manufacturing environment of medical or healthcare products and familiarity with ISO-13485 and FDA CFR 21 regulations
Six Sigma Green Belt or Black Belt certification
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;job_pub_nr=1406361A-E083-43EA-B31D-A60B7C589C76;p=homepage_com;job_pub_type=extern
Helix Medical is an Equal Employment Opportunity Employer.

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