Sr Quality Engineer - New Product Development

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 Quality Engineer who is:
o Responsible for managing design transfer and test method validations for new product development projects in the ear, nose, throat, head and neck surgery (ENT/HNS) market segments.
o Hands-on with a thirst for learning and logical problem solving working through our quality system.
o A big picture thinker who can execute project tasks within a scope of work to defined deadlines.
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 Cross functional team participation, representing Quality Engineering, on New Product Development (NPD) projects and products.
o Provide quality engineering review and support on NPD design planning, design inputs and outputs. Provides leadership in the identification and selection of Quality Characteristics. Create quality plans needed to ensure effective product acceptance including, but not limited to, inspection instructions, equipment and gage requirements, and sampling plans.
o Prepare and release Quality Control Inspection Criteria (QCIC) and Proforma documents for NPD projects and products.
o Provide quality engineering support and approval of test method validations, Verification and Validation strategies, activities, protocols, reports, etc.
o Provide quality engineering leadership and participation in risk management activities on NPD projects and products; supports legacy risk management activities as required along with maintaining the Annex II Certification with post-market surveillance.
o Represent Quality in NPD design reviews, stage-gate reviews, and design transfer to production.
o Provide leadership for the qualification of purchased components and suppliers; conduct supplier qualification assessments; participates in supplier selection as necessary.
o Audit NPD activities to ensure compliance with Helix Medical Quality System policies, procedures, standards (FDA, ISO 13485 and other worldwide regulatory agencies), and other applicable standards pertaining to medical devices; offer recommendations for continuous improvement.
o Provide support to manufacturing engineering on NPD products for equipment and process validation protocols and reports (IQ/OQ/PQ).
o Use statistical tools (Minitab, etc) to analyze data, make acceptance decisions, and improve process capability (Six Sigma, SPC, DOE) on NPD components and assemblies.
o Coordinate with manufacturing engineering, operations, QC, suppliers and product development teams on project matters, material issues, tooling and fixture design, process capability studies, and product quality issues for existing IHT processes, products and related projects, as required.
o Provide regulatory affairs assistance/support for the creation and maintenance of regulatory documents and submissions; provide other RA assistance, as required.
o Share technical expertise with others and helps develop junior level engineers.
Required Qualifications
o BS in Engineering discipline (ME or Plastics)
o 5 year's experience in a Quality Engineering or Quality Assurance position in a Medical Device Company.
o Experience in a medical device manufacturing environment including Class 7 and 8 cleanrooms.
o Demonstrated experience with problem-solving methodologies and deductive skills.
o Demonstrated experience with statistics, statistical problem solving, and DOE, Design transfer and test method validations.
o Working knowledge of FDA CFR 21 820.30 design control requirements, ISO 14971 Risk Management (FMEA severity/detectability and occurrence), and European MDD requirements.
o Working knowledge of metrology equipment, measurement techniques and gage/fixture design and operation.
o Working knowledge of project planning tools and project management.
o Ability to read, interpret and understand engineering drawings, including GD&T.
o Proficiency in the use of PC and programs, particularly Excel and Word.
o Ability to communicate ideas and information clearly, effectively, and frequently (oral and written).
o Ability to exercise judgment to determine methods, techniques and evaluation criteria for obtaining results.
o Able to prioritize tasks.
o Ability to communicate, coordinate, and be successful remotely with travel up to 50% at Product Development Office in Indianapolis, IN.
Preferred Qualifications:
o American Society for Quality CQE (Certified Quality Engineer)
o Six Sigma Green Belt or Black Belt.
o Experience with silicone and/or plastic injection molding and medical device assembly processes.
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=562B27D9-35DB-4CB5-A119-6111245FA42A;p=homepage_com;job_pub_type=extern
Helix Medical is an Equal Employment Opportunity Employer.

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