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 Lab Diagnostics Systems Engineering as a Staff Systems Integration Engineer in the Systems Engineering organization. The Systems Engineering organization is the technical hub for integrating the chemistries, mechanics, fluidics, robotics, electronics, and control systems to develop and launch new products for lab and molecular diagnostics. This role is open at our Lab Diagnostics headquarters site at Tarrytown, NY and there may be travel up to 25% to our other two sites at Flanders, NJ and Glasgow, DE.
This is a role well suited to an ambitious professional, looking for the next step in their career. As a Staff Systems Integration Engineer, you will be responsible for leading the assay and instrument integration activities in new product development and installed fleet support for laboratory and molecular diagnostics product lines.
The position reports to the Head of Systems Assay Integration & Verification within the Systems Engineering organization.
Responsibilities of Staff Systems Integration Engineer:
· You will be a leading team member to a group of engineers and scientists from diverse fields to drive the development of Laboratory and Molecular Diagnostics products from concept, design characterization, system and assay integration, verification, design transfer and through commercialization.
· You will work closely with product definition, design engineering, scientists (chemists / biochemists) to define the requirements for diagnostics products (clinical chemistry, immunoassay, and PCR molecular systems)
· You will develop into the Assay Integration Subject Matter Expert (SME) to support new product development and installed fleet for lab and molecular diagnostics product lines
· You will lead the design and integration of reagents/assays with laboratory and molecular diagnostic products that will meet the defined product/customer requirements
· You will conduct frequent and early confidence building testing to provide feedback/guidance and influence the design process
· You will direct and execute the verification for each diagnostic product
· You will develop into a key resource to support the validation of the diagnostic products
· You will participate in the design transfer to manufacturing by providing SME support to manufacturing engineering for test method development and manufacturing validation activities
· You will write plans, protocols and reports that are compliant with 21 CFR 820 and ISO 13485
· You will oversee, plan, and execute experiments to study design feasibility, and identify & characterize critical design parameters and their boundaries that influence assay performance
· You will identify solutions (hardware and software) to complex technical issues by troubleshooting, determine root cause, and then propose design modifications as they pertain to system & assay performance
· You will provide systems technical guidance and knowledge transfer to internal fleet support and service teams when instrument/assay performance issues arise at critical customer sites.
· You will analyze system & assay performance test data and establish acceptance criteria
· You will write & review data-driven technical summaries and test reports
· You will ensure compliance to all quality procedures and policies of product development. Oversees procedures pertaining to:
o System integration
o Engineering prototype configuration management during system verification
o Technical and Product Risk Management
o Design transfer to manufacturing
o Manufacturing /Quality Control Systems support
o Reliability FMEA and performance metrics
· You will collaborate with all Design and Commercial Product Engineering teams as well as Assay Development, Project Management, Marketing, and Sales
This position may suit you best if you
are familiar with what is below, and
would like to develop your career with Healthineers
· Hands-on experience with hybridization technology and next generation sequencing.
· Experience with nucleic acid sample preparation, including DNA/RNA extractions and target enrichment.
· Experience handling samples like purified DNA, bacterial pellets, fresh and tissue material, blood etc.
· Prior Laboratory and molecular commercial product experience, i.e., Versant, Roche, Abbott, Thermo Fisher, BD, Illumina, Pacific, Oxford, Agilent, Qiagen, Cepheid, etc.
· Experience implementing and troubleshooting IVD assays on a high throughput platform like the Hamilton STAR or Agilent BRAVO, especially script/protocol requirements development, authoring, & debugging
· Experience integrating other instruments (e.g., plate readers, sealers, barcode readers, mixers/shakers) with a high throughput platform like the Hamilton STAR or Agilent BRAVO
· Ability to use scripting or coding languages to control laboratory equipment
· Familiarity with the capabilities and challenges involved in an automated pipetting system
· Experience with Design of Experiments and Statistics analysis
· Experience in the development of at least one product that has successfully completed most of the product development phases i.e., Concept and Feasibility, Design, Verification, Validation, Design Transfer, Product Launch, Product Support
· Knowledge of FDA and international quality system regulations and processes. Familiarity with quality management system that supports medical device products and certifications -- 21 CFR 820 or CE mark
· Understanding of the electro-mechanical, software, mathematical, chemical, or biochemical process operations in diagnostic systems
· Knowledge of Systems Engineering best practices
· Six Sigma DFSS training
· Experience with Agile/Scrum
Required skills to have for the success of this role
- PhD in Chemistry/Biophysics/Biochemistry with 7+ years Medical Devices industry experience in new product development and installed fleet products.
- Experience implementing and debugging fluidic protocols on an automated high throughput (robotic) fluid transfer system
- Basic familiarity with laboratory/molecular diagnostics assays and lab practices
- Basic understanding of the steps involved in a laboratory/molecular IVD assay -- sample acquisition, sample prep, amplification, readout
- Skilled in systems thinking with a broad range of knowledge and experience in requirements, integration, and assay performance
- Work experience as part of large integrated, cross-functional teams.
- Strong verbal and written communication skills
- Learning mindset and clear thinker
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: Experienced Professional
Job Type: Full-time
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