Sr. Manufacturing Engineer

Apex Systems Irvine , CA 92606

Posted 3 days ago

Job Description: Job #: 1030225

Global medical device company in Irvine is seeking experienced Manufacturing Engineers to join their team!

Responsibilities:

  • 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

Skills Required:

  • 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

Education:

  • Bachelors degree in a related field such as mechanical, manufacturing, or industrial engineering is required.

EEO Employer

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 ] .


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