Now’s our time to inspire the future of healthcare together.
Siemens Healthineers is a leading global medical technology company with over 170 years of experience and 18,000 patents. More than 48,000 dedicated colleagues in over 70 countries are driven to shape the future of healthcare. We stand with our customers around the world to support them in delivering high quality care to their patients. An estimated 5 million patients across the globe benefit every day from our innovative technologies and services in the areas of diagnostic and therapeutic imaging, laboratory diagnostics and molecular medicine, as well as digital health and enterprise services. This is what truly matters to us.
Join our team now at Siemens Healthineers as a Technical Project Manager
This is a role well suited to an ambitious professional, looking for the next step in their career. As a Technical Project Manager, you will be responsible for:
· Development, planning, execution, and functionally direction of project(s) with complex features. Oversee all aspects of project work related to Manufacturing and Supply Chain on clinical chemistry assay product development teams to ensure that Manufacturing deliverables are completed in a quality compliant manner on schedule and that the test, release and manufacturing control systems for those products are established using the best manufacturing standards to ensure only the highest quality products are released to our clients.
· Coordinating/leading a network of personnel assigned to achieve project objectives.
· Leading commercial manufacturing support projects to address process or supply chain issues that impact production or quality. This will entail conducting troubleshooting activities as necessary to determine the root cause for failures and identify, implement and verify corrective actions. Should be able to plan and execute assay design verification and process validation studies.
This position may suit you best if you are familiar with what is below, and would like to do develop your career with Healthineers
- Complex project team management experience including managing projects for FDA-regulated clinical diagnostic or pharmaceutical products.
- Leading large and diverse teams that span multiple organizations. and influencing product design teams to develop products aligned with requirements for low-cost, low-overhead, high quality, sustainable manufacturing.
- Analysis of statistical product performance data to establish and determine sufficiency of process control parameters. This includes the assessment of such parameters to determine the robustness of the product design to consistently meet all performance specifications during manufacture.
- Designing, developing and commissioning new biochemical manufacturing processes and functional test methods as well as working in a FDA regulated environment and the use cGMP practices.
- Development of operational and test procedures, development of statistical process control and reporting schemes, process and product validations, project financing and cost estimation are highly desired.
- Lean Manufacturing & Quality Control principles.
Required skills to have for the success of this role
- A minimum of 5 years of experience in the production of biochemically-based medical devices and/or the development of statistical process controls for biochemically-based medical products. Demonstrated evidence that they can not only lead Manufacturing/Quality Control teams whose deliverables they are directly responsible for but also drive and influence product design teams to develop products aligned with requirements for low-cost, low-overhead, high quality, sustainable manufacturing. Candidate should be fluent with Microsoft Project, experienced in development of resource/headcount plans, operational, statistics, excel macro & workbook development,
- Minimum of 5 years of experience in designing, developing and commissioning new biochemical manufacturing processes working in a FDA regulated environment and be specifically familiar with cGMP requirements.
- Degrees in Biochemical Engineering, Chemical Engineering, Biochemistry or Chemistry preferred, however, other disciplines may be considered for candidates with greater than 5 years of project management experience in clinical diagnostics or pharmaceutical product manufacturing. Candidate must be familiar with safety aspects of bio-hazardous materials and provide technical support for regulatory submissions/registrations and be experienced in risk management practices including pFMEA and FTA’s.
- Ability to motivate and build strong working relationships in cross-functional project teams to develop technical solutions is a must. Additionally, the successful candidate will be expected to help identify, codify and train others on best new product introduction practices.
Siemens Healthineers has recently announced the next steps in our continued commitment to prioritize colleague health, comply with customer/business partner requirements, and help preserve our business continuity. Going forward, please be aware that Siemens Healthineers requires full vaccination for COVID-19 for our U.S. employees, contractors, and business partners, where local conditions allow, who:
1) Are customer-facing (e.g., those required to visit a customer/business partner site or interact in-person with customers at any conference or meeting) OR
2) Come on-site, whether regularly or occasionally, at any Siemens Healthineers location.
(Note: Accommodations may be requested for certain medical or religious reasons)
At Siemens Healthineers, we value those who dedicate their energy and passion to a greater cause. Our people make us unique as an employer in the med-tech industry. What unites and motivates our global team is the inspiration of our common purpose: To innovate for healthcare, building on our remarkable legacy of pioneering ideas that translate into even better healthcare products and services. We recognize that taking ownership of our work allows both us and the company to grow. We offer you a flexible and dynamic environment and the space to move beyond your comfort zone to grow both personally and professionally.
If you want to join us in transforming the way healthcare is delivered, visit our career site at https://usa.healthcare.siemens.com/careers.
If you wish to find out more about the specific before applying, please visit: https://usa.healthcare.siemens.com/about.
As an equal-opportunity employer we are happy to consider applications from individuals with disabilities.
Organization: Siemens Healthineers
Company: Siemens Healthcare Diagnostics Inc.
Experience Level: Mid-level Professional
Job Type: Full-time
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