Job Description: Job #: 1030225
Global medical device company in Irvine is seeking experienced Manufacturing Engineers to join their team!
Act as an operations technical leader for new products in the PDP process and its main interface between R&D, Pilot, and commercial manufacturing
Support operational transitions through development, clinical, and commercialization phases and ensure completion of Design Transfer
Responsible for the development of applicable Process Development (IQ/OQ/PQ) protocols and provide support for execution of validation plans and reports
Manage pilot production builds, planning, tracking and execution
Drive the development and manage the execution of complex experiments and tests (including writing an executing protocols) on new or existing product lines to qualify and validate manufacturing processes, analyze results, make recommendations, and develop reports
Responsible for Characterization and Validation activities, including CTQ flow-down and identification of critical control points within manufacturing
Leads development of pFMEA Act as the liaison between
Contract Manufacturing Organization (CMO), and to co-ordinate manufacturing activities as directed by the Manager of Operations Integration
Deploy manufacturing risk assessment and mitigations, including hands on and resourceful action plans
Responsible for part/drawing release, and accuracy of the Bill of Materials (BOM)
Review engineering product specifications, CAD data/drawing, as part of design review process to ensure they meet industry and manufacturing standards and practices
Ensure DFM, Six Sigma, and LEAN considerations are incorporated into product and process designs, including design and process 3P Provide analysis and track progress against agreed upon targets and deliverables
Minimum of four years of medical device manufacturing experience is required.
Technical expertise in the area of manufacturing engineering: design for manufacturability, design and process excellence methodologies including Six Sigma, LEAN experience, cGMP, EH&S guidelines, supplier development engineering and process validation.
Must be willing and able to travel up to 40% domestically, if required (take this line out for Connecticut posting)
Proven track record in design transfers to Operations and process, equipment validation experience
Understand injection molding, polymers and commonly used materials in the medical device space, such as Nitinol and implantable, with working knowledge of metals processing
Experience in developing process requirement specifications, collaborating with external parties, and working with Operations personnel to establish efficient solution systems
Excellent communication and interpersonal skills at all levels of employees including upper management, suppliers, operators and external parties.
Excellent problem-solving, organizational, analytical and critical thinking skills including high discretion/judgment in decision making
Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at [ Phone number blocked ] .