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 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.
Under the supervision of the Manager, Mechanical Process Engineering; the Mechanical Process Development Engineer is responsible for developing and executing process improvements and for generating and completing other technical activities and documents (e.g. Process and Equipment Validation protocols, Engineering Reports, Engineering Changes, Designed Experiments, Failure Modes and Effects Analysis, Test Method Developments) to support the efficient manufacturing of Epocal’s products in a manner consistent with CGMP and the Epocal QMS.
Duties and Responsibilities
- Proactively identifies the need for process development and improvement initiatives, and takes the lead on defining and implementing these initiatives. Improvements include more robust process control methodologies for existing processes. Where required, understands and uses appropriate statistical techniques to justify the efficacy and reliability of proposed improvements.
- Understands the Epocal Quality Management System and be able to successfully operate within its constraints.
- Establishes productive relationships with personnel from engineering, operations, quality assurance and other groups, including external contractors.
- Takes the lead on drafting new utilities, facilities, equipment and/or process validation protocols or modifying existing ones according to required process or product changes. Use established relationships with other groups to gather the required information for the protocols.
- Organizes and participates in required execution of validation protocols and drive the release of the corresponding report. Ensure that all groups affected by the execution are informed and are contributing appropriately.
- Communicates with supervisor and others when issues are detected and improvements required.
- Participates in test method improvements, Root Cause Analysis, pFMEA’s and Quality initiatives
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.
- Reports directly to the Manager, Mechanical Process Engineering
- Regular interaction with Manufacturing and Development engineers, technicians, and operators
- Ability to draft complex protocols related to Experimental Design and Process Validation.
- Attention to detail while maintaining the ability to multi-task and manage project timelines is essential
- Good communication and interpersonal skills
- Undergraduate degree in Chemical or Mechanical Engineering is desired, but other relevant disciplines such as Biochemistry, Biomedical Engineering or Engineering Physics may be considered. M.Sc. would be considered an advantage, and/or an equivalent combination of education and technical experience acceptable to Epocal
- Minimum of 3 years of related industrial experience
- Experience with process development and validation in a regulated industry such as pharmaceuticals or medical devices, are both highly preferred
- Experience with development of process control strategies is highly preferred
- Experience with Risk Analysis and Root Cause Analysis tools is preferred
- Demonstrated knowledge and skill in the use of statistical tools and application of statistical tools and application of statistical software programs (JMP, Minitab)
Organization: Siemens Healthineers
Company: EPOCAL INC.
Experience Level: Experienced Professional
Job Type: Full-time
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