Talent.com
Sr Engineer II, Process
Sr Engineer II, ProcessSound United • Irvine, CA, United States
Sr Engineer II, Process

Sr Engineer II, Process

Sound United • Irvine, CA, United States
[job_card.30_days_ago]
[job_preview.job_type]
  • [job_card.full_time]
[job_card.job_description]

Job Summary :

The Sr. Engineer II, Process is responsible for developing, improving, and validating new and existing manufacturing processes, equipment, tooling, and fixtures. This position leads and / or supports new process development (NPI) and product transfers to worldwide manufacturing facilities, implements and supports / utilizes effective manufacturing methodologies, such as Lean manufacturing, DFM, visual Workshop, SPC, etc., always following local and international regulatory standards (e.g. 21 CFR, Part 820 and ISO 13485 : 2003).

Duties & Responsibilities :

  • Assist in setting up World Class Manufacturing capability for the Company’s products.
  • Responsible for the design / specification / purchase / installation / qualification of the Company’s manual / automated assembly equipment and tooling.
  • Work closely with design engineering to proactively influence designs for better manufacturability.
  • Develop manufacturing plans, project timelines, requirements, specifications, and process flow.
  • Generate Manufacturing Assembly and In-Process Acceptance Procedures and train production personnel.
  • Develop the Validation Master Plans and perform process validations (IQ, OQ, PQ), including generating protocols and reports.
  • Perform line setup, line balancing, and build time studies.
  • Lead initial product builds (engineering units, pilot units, process validation units) and coordinate a smooth transfer of new products into production.
  • Develop Process Failure Mode and Effects Analyses (PFMEAs).
  • Conduct Design Reviews and prepare technical reports, analysis, recommendations, and presentations reflecting the status and results of projects in progress on a regular basis.
  • Establish Statistical Process Controls for Manufacturing Operations.
  • Technically support satellite manufacturing plants through effective communication.
  • Drive continuous improvement of engineering technical capabilities.
  • Continuously research, learn, and recommend best practices for world-class manufacturing.
  • Must be able to travel domestically and internationally.
  • Perform special projects as requested.

Minimum Qualifications :

  • At least seven (7) years of experience in engineering : process, manufacturing, or mechanical.
  • Experience with optical / electro-mechanical assembly and testing.
  • Experience in modern manufacturing principles and techniques.
  • Working knowledge of statistical techniques (e.g., DOE, SPC).
  • Experience in process automation, verification, and validation.
  • Excellent communication skills and technical writing abilities.
  • Excellent conceptual, analytical, and problem-solving abilities.
  • Excellent computer skills – SolidWorks (CSWA), word processing, and spreadsheets.
  • Ability to work effectively in cross-functional teams.
  • Ability to work onsite Monday - Friday in Irvine, CA.

    • Preferred Qualifications :

  • Proven experience in taking a major device from inception to customer shipment.
  • Proven work experience in process engineering.
  • Working Knowledge of 21 CFR, Part 820, and ISO 13485 : 2003 requirements.
  • Must be comfortable with integrating new technology into an existing business environment.
  • Experience with design, development, and validating manufacturing processes for an optical /  electro-mechanical device containing software.
  • Experience with cable assembly processes including cable preparation, hand soldering, crimping etc.
  • Experience with plastic injection molding.
  • Excellent CAD (SolidWorks) skills, CSWP.
  • Working knowledge of Geometric Dimensioning and Tolerancing (GD&T).
  • Demonstrated ability to manage large-scale projects and deliver results on time and within budget.
  • Design experience (the ability to design for manufacturability).
  • Basic device software knowledge.

    • Education : Bachelor’s degree in engineering : Mechanical, Electrical, Manufacturing or Industrial Engineering or related field is required.

    Compensation :

    [job_alerts.create_a_job]

    Sr Engineer II Process • Irvine, CA, United States

    [internal_linking.similar_jobs]
    Stationary Engineer I : Irvine Plant Operations

    Stationary Engineer I : Irvine Plant Operations

    Hoag Memorial Hospital Presbyterian • Irvine, CA, United States
    [job_card.full_time]
    Primary Duties And Responsibilities.Under general supervision, the Stationary Engineer operates and maintains equipment in both the Cogen plant and the power plant for Hoag Hospital and its affilia...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Process Engineering Technician II

    Process Engineering Technician II

    Confluent Medical Technologies • Laguna Niguel, CA, United States
    [job_card.full_time]
    Confluent Medical Technologies.We offer competitive pay and benefits to recognize the important role you will play in our life-saving work. Process Engineering Technician II.As a uniquely qualified ...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Additive Manufacturing Engineer

    Additive Manufacturing Engineer

    Saratech • Mission Viejo, CA, USA
    [job_card.full_time] +1
    [filters_job_card.quick_apply]
    Saratech is seeking an Additive Manufacturing Engineer.Ideal candidates will possess the following qualifications, experience, and abilities : . Efficiently operate all 3D printers.Must be willing to ...[show_more]
    [last_updated.last_updated_30]
    Quality Engineer I

    Quality Engineer I

    Sunrise Systems • Irvine, California, United States
    [job_card.full_time]
    [filters_job_card.quick_apply]
    The Quality Engineer is responsible for maintaining quality and control of manufacturing processes and post-market performance of medical devices. Responsibilities include collaborating with interna...[show_more]
    [last_updated.last_updated_30]
    Production Technician I

    Production Technician I

    Bio-Rad Laboratories • Irvine, CA, United States
    [job_card.full_time]
    In this role as a Production Technician I, you will be responsible for leading a production team and / or participating in a specific team or assignment. Duties may include working on a semi-automated...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Sr Application Engineering Lab Technician

    Sr Application Engineering Lab Technician

    Henkel • Irvine, CA, United States
    [job_card.full_time]
    At Henkel, you’ll be part of an organization that’s shaping the future through innovation, sustainability and collaboration. With our trusted brands like Persil®, ‘all®, Loctite®, Snuggle®, and Schw...[show_more]
    [last_updated.last_updated_variable_days]
    Sr. Security Engineer

    Sr. Security Engineer

    Golden State Foods • Irvine, CA, US
    [job_card.full_time]
    Golden State Foods is a distinguished leader in the foodservice industry, offering an extensive array of products and services to a diverse clientele. Rooted in the values of quality service and int...[show_more]
    [last_updated.last_updated_30]
    Software Engineer II - AI Enablement

    Software Engineer II - AI Enablement

    StubHub • Aliso Viejo, California, US
    [job_card.full_time]
    Job Description Job Description StubHub is on a mission to redefine the live event experience on a global scale.Whether someone is looking to attend their first event or their hundredth, we're he...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Manufacturing Team Member I (2nd Shift)

    Manufacturing Team Member I (2nd Shift)

    enVista • Pomona, CA, United States
    [job_card.full_time]
    Manufacturing Team Member I (2nd Shift).Essential Duties and Responsibilities : .Under direct supervision, follows work instructions to produce dental consumables including setting up equipment, weig...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Operations Supervisor I

    Operations Supervisor I

    CMA CGM • Ontario, CA, United States
    [job_card.full_time]
    CEVA Logistics provides global supply chain solutions to connect people, products, and providers all around the world.Present in 170+ countries and with more than 110,000 employees spread over 1,50...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Process Engineer

    Process Engineer

    TradeJobsWorkForce • 92619 Irvine, CA, US
    [job_card.full_time]
    Process Engineer Job Duties : Oversees and assesses existing processes and workflows.Optimizes pro...[show_more]
    [last_updated.last_updated_30] • [promoted]
    10062 – Software Engineer II

    10062 – Software Engineer II

    Hyundai Autoever America • Irvine, CA, US
    [job_card.full_time]
    [filters_job_card.quick_apply]
    Software Engineer II , Irvine (5-days Onsite) Company Overview Hyundai AutoEver America (HAEA), the dynamic IT powerhouse behind Hyundai Motor Corporation, a Fortune 500 global leader in the...[show_more]
    [last_updated.last_updated_30]
    Stationary Engineer- Mid shift

    Stationary Engineer- Mid shift

    City of Hope • Irvine, CA, United States
    [job_card.full_time]
    About City of Hope Orange County.City of Hope Orange County is transforming cancer treatment by bringing world-class expertise and specialized care closer to home. Supported by a regional network of...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Systems Engineer (onsite)

    Systems Engineer (onsite)

    Palomar Products Inc. • Rancho Santa Margarita, CA, US
    [job_card.full_time]
    [filters_job_card.quick_apply]
    Summary Palomar Products is seeking a Systems Engineer to support the development of our next-generation Intercom System for military aerospace platforms. This role will drive system-level requireme...[show_more]
    [last_updated.last_updated_30]
    Senior Software Engineer II

    Senior Software Engineer II

    EBizCharge and Century Business Solutions • Irvine, CA, United States
    [job_card.full_time]
    EBizCharge specializes in developing integrated payment solutions that facilitate electronic payment processing within ERP, CRM, Mobile, and eCommerce applications. Our applications are PCI complian...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Senior Quality Engineer

    Senior Quality Engineer

    Design West Technologies, Inc. • Tustin, CA, USA
    [job_card.full_time]
    [filters_job_card.quick_apply]
    The successful candidate will be responsible for providing quality interface and expertise within the business unit, establish and maintain quality management systems (ISO-9001 and AS9100D), which ...[show_more]
    [last_updated.last_updated_1_day]
    New Product Introduction Engineer

    New Product Introduction Engineer

    Camellia Metal • Irvine, California, US
    [job_card.full_time]
    Job Description Job Description Position Overview : The NPI Engineer will lead new wiring harness programs from customer design through stable production. This role is hands-on and highly cross-fun...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Specialist II, Engineering

    Specialist II, Engineering

    Terumo Neuro • Aliso Viejo, CA, United States
    [job_card.full_time]
    Perform medium sized and intermediate complex aspects of product / process development.Based on new product concepts and designs from engineers, support the development of products / processes for medi...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]