Senior Advanced Manufacturing Engineer (Injection Moulding)
Senior Advanced Manufacturing Engineer (Injection Moulding)
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Job Description
Senior Advanced Manufacturing Engineer (Injection Moulding)
As one of the worlds leading manufacturers of cardio- and endovascular medical devices BIOTRONIK is headquartered in Berlin Germany and represented in over 100 countries by its global workforce. The work of our committed highly specialized exceptionally skilled employees results in crucial advancements in the world of cardiology and changes the lives of patients every day.
PURPOSE OF THE POSITION
The Senior Engineer Advanced Manufacturing Engineering (AME) plays a very critical role in product development projects as well as production transfer projects by ensuring the successful transfer & implementation of new manufacturing processes in the BIOTRONIK APM II site.
An AME specializes in the following areas:
- Perform comprehensive analysis to support make-buy decision making process
- Perform analysis to identify the manufacturing facilitys needs
- Liaise with vendors and suppliers to purchase materials and equipment
- Managing budgets and timelines
- Assess existing systems and methods to find areas needing improvement
- Implement solutions against problem areas
- Develop and implement product quality standards and ensure compliance with industry regulations
- Provide technical guidance and support to cross-functional teams including engineering manufacturing and sourcing
The Senior Engineer AME is responsible for co-ordinating with cross functional teams whose main objective is to ensure the successful transfer & implementation of new manufacturing processes in the BIOTRONIK APM II site. The role would be required to station in Berlin headquarters on an assignment basis for a period of up to 1 to 2 years.
ESSENTIAL JOB FUNCTIONS
- Partner with Project Managers to lead a cross-site multi-departmental project core team to set up and integrate new manufacturing processes into the Singapore manufacturing plant including:
- Support product development projects by providing inputs for Design For Manufacturing (DFM)
- Initiate Change Request (CR) for projects.
- Source and identify competent suppliers using appropriate tools such as Supplier Evaluation Matrix
- Conceptualize document and procure fixtures tools and equipment for serial manufacturing.
- Support and coordinate to ensure infrastructure (Floorplan Facility Media) readiness
- Work with project team to establish Device Master Records (DMR) as well as all systems (SAP MES and middleware) set up to ensure long term stable production.
- Plan and execute all validation plans (PPFU IQ OQ PQ) for equipment and processes within project scope
- Plan training strategies for operations team
- Plan coordinate and deliver all requirements for product validation and regulatory submissions
- Plan coordinate and execute pilot phase runs
- Provide necessary support to production engineers in ramp up of implemented manufacturing line
- Follow up on the objectives (quality costs deadlines) initiate and implement all necessary mitigation actions
- Monitor project progress and present it internally and externally through regular reporting.
- Plan and conduct internal as well as cross site team meetings.
- Identify present and address risks; implement and monitor measures.
- May perform other duties as required.
TECHNICAL COMPETENCY
Statistical skills:
- Optimize of parameters with DOE.
- Identify area of need for Measurement System Analysis plan and execute MSA analysis the collected data and derive corrective actions.
- Conclusion of hypothesis testing with statistical means.
- Identify Special and Common cause variables and take appropriate actions to address them.
- Define and determine the process capability of respective processes.
Process Engineering:
- Plan and coordinate process qualification activities (IQ OQ PQ)
- Implement concepts of mistaking proofing (Poka-Yoke) Single Minute Exchange of Die (SMED) into assembly tooling and fixtures.
- Utilize 5S 7-Mudas Kaizen Process flow Spaghetti diagrams for production flow optimizations.
- Plan develop improve and maintain Value Stream Mapping (VSM).
- Relate plan validate co-ordinate with vendors for integration semi/automated of manual processes.
- Support engineering processes such as deviations FMEAroot causes analysis.
- Utilize DMAIC Ishikawa PDCA A3 Problem Solving in day-to-day management of project activities
Your Profile
- Bachelors Degree or Diploma in Plastics Biomedical Material Chemical Electronics Mechanical or Industrial Engineering;
- Degree holders: At least 5 years of relevant working experience in production engineering and/or New Product Introduction (NPI) for Injection molding operations
- Diploma holder or equivalent: At least 9 years of relevant working experience in production engineering and/or New Product Introduction (NPI)
- Strong technical background in injection molding processing tooling equipment manufacturing and quality
- Prior experience in both Liquid Silicon Rubber (LSR) and thermoplastic (E.g. PEEK) is preferable
- Prior engineering experience in the medical devices industry is preferable.
- Prior experience in project management PMP certification will be a plus
- Familiar with ISO13485 and GMP.
- Excellent skills in Microsoft applications (Excel Word PowerPoint Visio etc)
- Basic knowledge in SAP and MES is preferable.
- Strong organizational communication presentation and intercultural skills.
What We Offer
- Being encouraged to think and act entrepreneurially.
- Working in global teams and projects.
- Developing yourself professionally.
Are you interested Please apply online through our application management system! We are looking forward to welcoming you.
Location:Singapore Working hours: Full-time
Apply now under: ID: 60585 Contact: Human Resources
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race color religion age sex sexual orientation gender identity or expression national origin disability status protected veteran status genetic information or any other characteristic protected by law.
Required Experience:
Senior IC
Employment Type
Full-Time
