The Project Manager, Product Transfer, is responsible for effectively managing strategic projects involving the transfer, validation, regulatory approval and ramp-up of product and manufacturing process technology into the BIOTRONIK Singapore site.
He/she is responsible for managing a cross-functional project team, all project schedules, resource allocation, costs, risks and required mitigation, and reporting to the site and global business leadership. The Project Manager establishes and maintains effective communication with the site departments Operations, R&D, Quality, Supply Chain, Procurement, IT, Finance, Human Resources, and Real Estate, as well as to the System House Project Management organization, Regulatory Affairs, Product Management, and other stakeholders.
Your Responsibilities
Prepare, plan and control cross-location projects:
- Maintain overall responsibility for project goals in terms of costs, time and quality
- Provide leadership in driving Cross-Site Interfacing Processes, defining clear roles and responsibilities for all functions within the project
- Accountable for designing and executing proper planning, including creation of the project work breakdown structures, identification of critical path and contingency planning, using appropriate project management software and tools. Maintains a high level of personal direct engagement in the day-to-day activity of the team.
- Document the project and any sub-projects using appropriate project management tools. Structure projects and break them down into individual work packages
- Plan financial and human resources details and work with the specialists in relevant functions to execute all related tasks
- If necessary, carry out profitability and investment ROI/payback time analyses with support from Finance
- Manage and report opportunities and risks with the project, and escalate to the steering committee topics requiring higher level decisions
- Plan, control and monitor project management, set priorties (in the case of sub-projects in consultation with the overall project manager)
- Monitor project progress and present it internally and externally through regular reporting
- Plan and conduct team meetings - also across locations
- Identify, present and address risks; Initiate and monitor measures
- Follow up on the objectives (quality, costs, deadlines), initiate and implement all necessary corrective actions
- Plan and carry out milestone reviews
- Plan and ensure the flow of information to all stakeholders, including across sites
- Select and professionally manage employees taking into account suitability and qualifications as project participants, in coordination with line managers
- Define and coordinate work packages, delegate work execution, check and discuss work results
- Propose qualification and support measures
- May perform other duties as required
Your Profile
- Technical or Business Bachelor’s degree required or equivalent work experience
- PMP Certified
- Industrial Engineering / plant design background
- DFSS, Six Sigma, Lean Six Sigma Green Belt Certified
- Agile certifications such as SAFe, PMI-ACP, CSM, CPO are an asset
- Minimum of 10 years’ experience in regulated industry with functional association to Operations, Process Engineering, Quality, Research and Development
- Must demonstrate practical experience in Program Management leadership managing multiple projects and or programs within a highly regulated industry (e.g. medical device, pharmaceutical, avionics, automotive)
- Knowledgeable Leader with problem-solving skills, able to find innovative ways to resolve issues. Trained in Lean Six Sigma, TQM, or other problem-solving methodologies
- Ability to lead teams comprised of individuals with diverse backgrounds; including but not limited to R&D, Process engineering, Manufacturing, MES, IT, and Quality Management team
- Ability to work in a highly matrixed and geographically diverse business environment
- Strong leadership skills, including the ability to set goals and provide positive and constructive feedback to build positive relationships and improve business results.
- Excellent communication and interpersonal skills, negotiating; planning and organizing teamwork; ability to address difficult situations; conflict resolution; resource constraint and problem solving. Strong written communication skills.
- Technically savvy; must be able to discuss and understand decisions regarding a wide array of engineering disciplines and complex technical/logistical issues.
- Strong and broad skills using the tools and techniques of Project Management. Successfully managed multiple projects from conception through commercialization. Experience in the medical device industry. Exposure to systems engineering, concept engineering, hardware and software development, validation and systems integration.
- Demonstrated knowledge of budgeting and resource allocation
- cGxP Know-How incl. regulations ISO 13485, FDA 21 CFR 820, MDD 93/42/EEC, EU MDR
- Class III or II medical device experience (catheter and leads experience preferred)
- Knowledge of SAP Systems
- Knowledge of Manufacturing Execution Systems
What we offer
- being encouraged to think and act entrepreneurially
- working in global teams and projects
- developing yourself professionally
