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

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