Project Manager - Medical Devices - InHealth Technologies

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 Project Manager-InHealth Technologies who is:
o Responsible for managing new prototype development projects, and also new production launches using established design control procedures and project management practices, with the goal of flawless launch of new products to production.
o Leading the project implementation for all product lines manufactured at this location of Helix Medical including proprietary products for InHealth Technologies.
o Be the primary point of contact for InHealth product development, suppliers and vendors to present technical solutions with a focus on quality products.
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 Leads cross-functional teams of resources, drawing from other functional areas, to ensure on-time delivery and a flawless launch to production utilizing established Advanced Product Quality Planning (APQP) and Project Management Institute (PMI) best-practices.
o Provides leadership to comply with, and maintains documentation in accordance with Helix Quality System Requirements (QSR), FDA cGMP, internal procedures, customer requirements and notified body requirements.
o Leads the design control process developing and maintaining the DMR, DHF, PMF from prototype through production launch
o Responsibility includes conceptualizing and defining new and/or modified product specifications while also providing accurate and timely recommendations of proposed processes/equipment, tooling and fixtures along with costs.
o Participates in the selection and development of strategic production partners as well as input in the "make or buy" decision process.
o Provides leadership to manage multiple projects and production launches using established APQP and PMI best-practices.
o Responsible for managing and developing the Graphics Specialist and Packaging Engineer
o To develop accurate and timely manufacturing methods and processes in response to customer or internal inquiries.
o Develop and implement new or improved product test methods and statistical methodology to improve product performance and reliability. Test and measurement fixture requirement identification.
o Oversee and manage production process and documentation sustaining maintenance and improvement. Effectively facilitate communication between manufacturing, sales, marketing and product development and ensure coordination of production for assigned product families.
o Ability to lead all phases of product development cycle to support the complete definition of project/product at the conclusion of the feasibility studies.
o Maintain effective working relationships and communicate project status to internal and external stakeholders.
o Identify project constraints and risks and develop action plans to overcome or eliminate potential project delays.
o Measures, reports, and continuously improves performance metrics (KPIs) of the product development and launch process.
o Guide, develop and create design and process documentation in accordance with company policy, ISO 13485 and FDA cGMP regulations.
Required Qualifications
o Bachelor's degree in a related technical field such as Mechanical Engineering, Chemistry or Plastics Engineering
o 10 + years' of related experience in a regulated manufacturing environment, preferably medical or healthcare product design.
o Working knowledge of ISO-13485 and FDA cGMP regulations.
o Experience in advanced engineering/statistical problem solving methods is required, including Design of Experiments (DOE).
o Working knowledge of ERP/MRP software
o Strong interpersonal, oral and written communication skills with the ability to effectively communicate with all levels of the organization, customers and suppliers.
o Ability to understand engineering drawings (including Geometric Tolerancing & Dimensioning). A working knowledge of tool designs, rubber compound characteristics, as well as transfer/injection press mechanics is a plus.
o Working knowledge of engineering terminology, extrusion and injection molding processes, tooling and validation protocols.
o Proficient in MS Project, Word and Excel. Experience with solid modeling and CAD software.
Preferred Qualifications:
o A working knowledge of Process Failure Modes and Effects Analyses (PFMEA). A working knowledge of Value Analysis/Value Engineering (VA/VE) is a plus.
o PMP Certification in Project Management.
o Lean Systems or Six-Sigma Green Belt Certification is a plus.
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=72FF1BD2-AF9F-40CE-B8BF-8EC21647A1E0;p=homepage_com;job_pub_type=extern
Helix Medical is an Equal Employment Opportunity Employer.

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