Job Description

Senior Advanced Manufacturing Engineer
As one of the worldxc2xb4s 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 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.

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: www.biotronik.com/careers
Job 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.