Job Description
DUTIES: The Senior Engineer for Cardiac Implantable Network is a technical role supporting all implant manufacturing sites by ensuring that all injection molded parts used in commercial environment are robust, harmonized & scalable utilizing best technologies, process capable, validated per design control and compliant with Regulatory requirements. This role provides oversight for injection mold tooling and injection molding processes including design for manufacturability, process optimization and production release at suppliers. Project management is a key function of this role and includes formal project planning and tracking. In addition, this role is part of a cross-functional team that is responsible for supporting sourcing strategies including supplier recommendation, evaluation and development. This position reports directly to the Senior Manager, Molding Engineering and 3D Printing and resides in the Irvine location. • Support Manufacturing and R&D in plastics engineering, injection mold design/construction and injection mold processing. Apply technical knowledge to innovate, design, develop processes, define requirements, establish procedures and implement tooling in support of thermoplastic injection molding and silicone liquid injection molding (LIM). 20% • Support thermoplastic and silicone processing and tooling troubleshooting, and drive problem solving with suppliers. 15% • Manage the implementation of new injection molds at suppliers. Drive process optimization and capability using scientific injection molding principles including process improvement opportunities and innovation on commercial products. 20% • Contributor to Design for Manufacturability (DFM) input during product development phases including plastic part design and mold design & construction. 15% • Project management from feasibility through implementation including charter & scope, detailed plan, defined schedule, risks mitigation, progress report and cost management. Escalate project risks to management, as required. In addition, plans, organizes, and conducts all aspects of technical reviews. 15% • Supports IQ/OQ/PQ efforts within Edwards and at suppliers. Ensures proper documentation is completed to meet quality systems requirements. (e.g., Design Reviews, Component Dwgs, FMEA’s, Mfg Procedures, BOM’s, Routers, etc.) 5% • Participate cross-functionally (Engineering, Quality, Validations, Regulatory Affairs, and Operations) and across implant manufacturing sites to support strategies including capacity, supplier sourcing, logistics, equipment and processes to meet key business goals. 5% • Other incidental duties 5%
SKILLS: There may be some flexibility on a higher rate if we found a person with strong skillset in plastics injection molding processing in addition to project management and the other typical requirements (e.g., communication, problem solving, IQ/OQ/PQ validations, supplier development). The Expert is desired expertise, but General Knowledge is acceptable. Expert – Plastics Injection Molding Processing This role provides the expertise and guidance for injection mold tooling and injection molding processes including design for manufacturability, process optimization and production release at suppliers. Project management is a key function of this role and includes formal project planning and tracking. In addition, this role is part of a cross-functional team that is responsible for supporting sourcing strategies including supplier recommendation, evaluation and development. General Knowledge – Plastics Injection Molding Processing This role provides close oversight for supplier’s technical performance including design for manufacturability, process optimization and production release. Project management is a key function of this role and includes formal project planning and tracking. In addition, this role is part of a cross-functional team that is responsible for supporting sourcing strategies including supplier recommendation, evaluation and development. • Technical knowledge and hands-on experience in the area of Engineering Leadership with general understanding in plastics engineering, injection mold design & construction and injection mold processing • Proven successful project management skills. Ability to manage competing priorities in a fast-paced environment • Supplier relationship building, development and project support • Problem-solving, analytical and critical thinking skills including high discretion/judgment in decision making • Knowledge of technical operations, preferably including medical device, process excellence methodologies such as Six Sigma, and FDA regulations, cGMP, ISO standards and EH&S guidelines • Excellent documentation, communication and interpersonal skills. Ability to translate complex and technical information to all levels of the organization • Innovative and strong execution skills with a demonstrated ability to deliver on short- and long-term strategic goals • Proven expertise in IT platforms, preferably Microsoft Office Suite and manufacturing systems (PLM, Ignite), and CAD experience • Ability to travel approximately 20%: domestic and international EDUCATION: A Bachelor's degree in engineering is required, preferably Plastics. Advanced degree is desirable. Minimum of four (4) years of experience in providing technical engineering support, preferably medical device manufacturing, and demonstrated track record in executing large scale projects.
Company Description
We are an equal opportunity employer and make hiring decisions based on merit. Recruitment, hiring, training, and job assignments are made without regard to race, color, national origin, age, ancestry, religion, sex, sexual orientation, gender identity, gender expression, marital status, disability, or any other protected classification. We consider all qualified applicants, including those with criminal histories, in a manner consistent with state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.