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.

Don't Be Fooled

The fraudster will send a check to the victim who has accepted a job. The check can be for multiple reasons such as signing bonus, supplies, etc. The victim will be instructed to deposit the check and use the money for any of these reasons and then instructed to send the remaining funds to the fraudster. The check will bounce and the victim is left responsible.

More Jobs

Sr. Communications Specialist
Cambridge, MA Pegasystems, Inc.
Case Management Specialist Sr
Cambridge, MA Sanofi Group
ATM/Check Processing Specialist
Waltham, MA Accountemps
CE Engineering Service Rep Specialist Imaging ...
Springfield, MA Baystate Health
Recovery Specialist, HART House *Sign on bonus...
Tewksbury, MA Lahey Health
Recovery Specialist, Tewksbury Transitions
Tewksbury, MA Lahey Health