Epocal, part of Siemens Healthineers, is a leading manufacturer of a clinical Point Of Care (POC) diagnostic product. The epoc© Blood Analysis System is healthcare’s first cost-effective POC testing solution to leverage Smartcard Technology and wireless communication to provide caregivers with real-time, lab-quality blood gas, electrolyte, and metabolite (BGEM) results at the patient bedside. This system is now a well-established tool of the medical profession available worldwide. Epocal is committed to delivering high-quality products and services that patients and providers can rely on for consistently accurate and actionable information. We deploy unique innovative technologies that not only transform diagnostic products, but also expand into new platforms and solutions with proven health and economic outcomes.
Epocal was acquired by Siemens Healthineers in October 2017. As a leading global healthcare company, we at Siemens Healthineers develop innovations that support better patient outcomes with greater efficiencies, giving providers the confidence, they need to meet the clinical, operational, and financial challenges of a changing healthcare landscape. As a leader in medical imaging, laboratory diagnostics, and healthcare information technology, we have a keen understanding of the entire patient care continuum – from prevention and early detection to diagnosis and treatment.
For more than 100 years, Siemens Healthineers in Canada has helped healthcare providers achieve their goal of improving outcomes while reducing costs. From the Atlantic to Pacific oceans, more than 450 employees in Canada work together to deliver solutions for healthcare providers, resulting in 70% of medical decisions being influenced by the technologies we provide.
More information is available at: www.siemens-healthineers.ca
Under the supervision of the Sr. Director Assay Systems, the Sr. Research Scientist, Assay Systems is responsible for acting as the technical lead in designing, verifying, validating and transferring to production electrochemical/optical-based clinical assays on Epocal's platform (card and reader). May include additional optical assays (e.g. COOx), enzyme assays, or coagulation assays (e.g. ACT, PT).
Duties and Responsibilities
- Lead technical problem solver in designing, characterizing and optimizing assays, sensor formulation and processing and platform programming (optical/electrochemical parameters, algorithm development)
- Design, perform, analyze and summarize experiments leading to the design and characterization of electrochemical and/or optical assays.
- Key in the development of an optimized production process and associated QC fluids/systems for electrochemical/optical assays.
- Organize and perform the design verification and validation studies, including clinical trials, of new and existing assays
- Chief in the preparation of 510k application(s) and other regulatory activities
- Prime in construction of the design history file and device master record.
- Main interface with the production team as well as other resources needed to ensure effective and efficient transfer to production.
- Expert product support after launch assisting manufacturing, QA/RA, sales and marketing, technical support teams as needed
· Skillful support for other R&D departments within Siemens
Note: Duties are not limited to those listed above. Additional duties may be assigned as required. However, reasonable accommodations will be made if all possible under business conditions.
- Sr. Director Assay Systems
- Colleagues in the Assay Systems group
- Works with a broad range of individuals including but not limited to R&D, Manufacturing, QA/RA, Softwrae development, Product Health, Corporate Sales & Marketing, Technical Support, epoc system Implementation.
- Demonstrate strong business acumen by successfully integrating into a highly multidisciplinary team
- Successfully manage tasks and deadlines within a busy and strongly inter-dependent work environment in collaboration with key business areas, including but not limited to: Sales, Marketing, and Manufacturing
- Provide technical leadership and support to all areas of the company while assuming Project Management responsibilities for assigned tasks
- Work effectively in a team setting and demonstrate commitment to effectively manage change
- Adapt to priorities as opportunities or issues arise
- Successfully deliver on assigned tasks in tandem with requirements of a regulated quality system environment
- Provides effective communication, both orally and written, with peers and management
- Proves integrity, professionalism and overall commitment to excellence in completion of assigned task
- A sense of urgency and results orientation with a dedicated focus toward product launch
- Extended period of sitting/computer use
- Extended period of standing/card testing
- Manual dexterity
- Ability to distinguish colors/read/write charts
Skills & Qualifications (Education and Experience)
- 7+ years of relevant industry experience
- Masters and/or PhD in any of the following or a related field: Physics, Chemistry, Biochemistry, and/or an equivalent combination of education and technical experience acceptable to Epocal.
- Analytical chemistry, clinical chemistry, optics and/or electro-chemical background desired
- Thorough understanding of statistical methods and analysis
- Focus on applying and expanding acquired knowledge base
- Experience with application of knowledge in increasingly broader professional and managerial context
- Experience with Product Engineering, design validation-verification and product implementation is required
- Experience in managing compliance with all safety standards, proper guidelines and production methods, etc
- Proficient knowledge of MS Office (Word, Excel, Outlook and PowerPoint)
- Experience with coagulation assays and/or co-oximetry is highly desirable.
Organization: Siemens Healthineers
Company: EPOCAL INC.
Experience Level: Experienced Professional
Job Type: Full-time
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