Manufacturing Process Engineer III

Company: BioSpace, Inc.
Location: Dublin
Posted on: March 19, 2023

Job Description:

Job Details

Overview: Responsible for supporting the manufacturing production line and optimizing manufacturing processes, from engineering change control through the production and shipment of product. This includes review of BOM's and accurate translation into SAP.

Essential Duties and Responsibilities:

• Review ECO's to ensure correctness of the BOM's and transfer the information from Arena (our document control system) into SAP.
• Check, validate, and enter the Item Master to ensure correctness.
• Work with Production and Materials groups to address BOM issues, in order to facilitate accurate and efficient back-flushing and inventory management.
• Help to manage ECO's for operations implementations into the production environment.
• Design and facilitate proper materials management on the production floor.
• Perform time studies, when needed, to assess line capacity and to identify areas to improve.
• Create and maintain a model of the production line to determine capacity and proactively initiate purchase requests for additional equipment, furniture, tooling, and fixtures that will be needed for volume increases.
• Create layouts and execute plans to expand the production line, and to add new products in a manner that optimizes floor space.
• Improve production line efficiency, flexibility, and work environment to improve yield, capacity, and product quality.
• Lead projects to introduce new products to the production line and to improve existing tooling, fixtures, and procedures.
• Document and update work instructions, as needed to maintain and improve the production line.
• Track and report production yields, improving them to meet goals.
• Perform investigations into line failures, NCMRs, and line issues, and document findings accordingly.
• Assist in the processing of NCMRs, when needed.
• Perform engineering work typically including one or more of the following:
• Process/product improvements.
• Process development including IQ/OQ/PQ.
• Process improvements including Validation & Verification.
• Product design for manufacturability, testability and serviceability.
• Production line layout & facility requirements.
• Report preparation.
• Provide training for line personnel, particularly on new processes and process improvements.
• Lead and/or participate on project teams to design, develop, and continuously improve product, equipment, fixtures, and/or processes.
• Perform failure analysis on failed units from field returns.
• Work with Quality to resolve part quality issues from supplier/vendors.
• Reduce costs through manufacturing process improvement or component costs.
• Establish production tooling stock supply chain to make sure there is no shortage on tooling materials. Qualifications:
  • Bachelors degree in electrical, mechanical, or industrial engineering, or equivalent technical degree, plus 6 years of relevant experience in a manufacturing environment is preferred.
  • Experience using SAP or other enterprise system to set up BOM's and parts management in support of a manufacturing line is preferred.
  • Arena (or equivalent change management system) experience is preferred.
  • Experience in an FDA regulated manufacturing environment and proficiency with medical device development life cycles is preferred.
  • Ability to focus on and achieve scheduled milestones, including contingency planning is required.
  • Knowledge and understanding of FDA regulations (21CFR 820), ISO13485, and ISO standards related to medical device manufacturing is preferred.
  • Strong team-working and communication skills. A drive to get the job done in the face of obstacles and time constraints, and a willingness to jump in wherever needed.
  • Ability to use MS Excel to perform calculations, charting, and interpret results/data.
  • Competent using office software including MS Word, Excel, Internet Explorer, PowerPoint, and Outlook. Pro-E competency is desirable.
  • Individual must have excellent verbal and written communication skills and a demonstrated ability to communicate clearly and professionally.
  • Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.
  • Ability to read, understand and abide by company procedures. Ability to define problems, collect data, establish facts, draw valid conclusions and report on findings. Additional Requirements:
    • Responsible for performing all duties in compliance with FDA's Quality System Regulation (QSR), ISO13485, the Canadian Medical Device Regulations, and all other international regulatory requirements with which ZELTIQ complies. Physical Requirements:
      The physical demands and work environment described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
      
      While performing the duties of this job, the employee is regularly required to sit, stand, walk, talk and hear; up to 8 hours per day. The employee is regularly required to lift and carry up to 10 pounds and occasionally lift and carry up to 25 pounds. Duties also involve daily keyboard data entry. Specific vision abilities required by this job include close vision.
      
      Applicable to California Applicants Only
      • The below range is the range that we in good faith believe is the range of possible compensation for this role at the time of this posting. We may ultimately pay more or less than the posted range and this range is only applicable for jobs to be performed in California. This range may be modified in the future.
        • The salary range is (minimum: _$74,500 to maximum:_$145,500)
        • This job is eligible to participate in our short-term incentive program
        • This job is eligible to participate in our long-term incentive programs
          • We offer comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
            • Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole discretion unless and until paid and may be modified at the Company's sole discretion, consistent with the law.
              AbbVie is an equal opportunity employer including disability/vets. It is AbbVie's policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a disabled veteran, recently separated veteran, Armed Forces service medal veteran or active duty wartime or campaign badge veteran or a person's relationship or association with a protected veteran, including spouses and other family members, or any other protected group status. We will take affirmative action to employ and advance in employment qualified minorities, women, individuals with a disability, disabled veterans, recently separated veterans, Armed Forces service medal veterans or active-duty wartime or campaign badge veterans. The Affirmative Action Plan is available for viewing in the Human Resources office during regular business hours.

Keywords: BioSpace, Inc., Dublin , Manufacturing Process Engineer III, Engineering , Dublin, California