Senior Advanced Manufacturing Engineer
$ 5,000 - $ 8,000 / month
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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 facility's 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, FMEA, root causes analysis.
- Utilize DMAIC, Ishikawa, PDCA, A3 Problem Solving, in day-to-day management of project activities
Your Profile
- Bachelor’s 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.
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 facility's 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, FMEA, root causes analysis.
- Utilize DMAIC, Ishikawa, PDCA, A3 Problem Solving, in day-to-day management of project activities
Your Profile
- Bachelor’s 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.