Epocal Career Opportunities
At this time, we are currently scheduling interviews for the following positions:
At this time we are hiring for the following positions:
- Director of Clinical Affairs
- R&D Scientist
- Senior Research Scientist - Immunoassay
- System Support Engineer (US Based)
- Senior Process Engineer
- Senior Mechanical Engineer
- Accounting Analyst (Accounts Receivable)
- Process Engineer (Card Manufacturing) - Second Shift
- Chemical Preparation Technician (Card Manufacturing) – Second Shift
- Software Engineer - Applications
Director of Clinical Affairs
Responsible for developing Epocal’s Clinical Affairs strategy. The candidate will demonstrate the ability to understand the clinical, medical, economic and regulatory issues in the point-of-care markets and provide advice and input to management on appropriate actions to ensure that the medical and regulatory actions and solutions are aligned with business decisions. The role will guide the research, development and implementation of Epocal products for blood gas, blood chemistry, hematology, coagulation and immunoassay testing applications.
Major Activities:
- Perform market research regarding scientific and medical principles and best practices for current and future products
- Advising research and development staff on the scientific and medical risks and benefits of products under development
- Advising customers on proper procedures and interpretations for regulatory compliance (QC and proficiency for CLIA, CAP, or others)
- Working with customers to resolve clinical performance issues
- Developing a thorough understanding or operating principles and attributes of methodologies of Epocal's products and competitors' products in order to advance the knowledge of Epocal's products in the marketplace, and to advance Epocal's understanding of performance concerns and requirements of the clinical community
- Providing concise, accurate information (white papers, presentations) for Epocal's customers and partners on various and sometimes complex aspects of point-of-care, in-vitro diagnostics as it relates to Epocal's products
Requirements:
- Pathologist, Clinical Chemist or Laboratory Manager of a major hospital.
- MD or PhD with 10 years experience in blood testing, or in-vitro diagnostics related field.
- Experience working and communicating with the FDA or another national equivalent in Canada or Europe.
- Thorough knowledge of in-vitro diagnostic method analysis protocols such as CLSI protocols for precision, calibration verification and method comparison with understanding of clinically significant errors and method differences.
- An understanding of the global scientific, medical and regulatory principles of point-of-care testing
- Excellent communication skills and a thorough understanding of the terminology used in complex scientific medical disciplines.
- The ability to analyze medical and scientific trends to provide direction to the development of products and services.
- A track record of successful accomplishments in the area of medical and regulatory activities, product approvals and drug safety.
Description:
Member of the Clinical Sensors Team in charge of designing, validating and transferring to production metabolites sensors based on electrochemical principles
Major Activities:
- Design, perform analysis and summarize experiments leading to the design and characterization of electrochemical sensors for matabolites detection.
- Assist with the development of an optimized production process for electrochemical sensors for metabolites detection.
- Assist with the product validation (clinical trials, in-house trials, data analysis and report writing).
- Assist with the preparation of the 510K application.
- Participate in construction of the design history file and device master record.
- Interface with the production team as well as all other resources needed to ensure smooth transfer to production.
Requirements:
- B.Sc. or M.Sc. in Chemical Engineering, Analytical Chemistry, Electrochemistry, Clinical Chemistry, Biomedical Engineering or related disciplines.
- Solid analytical chemistry, clinical chemistry and/or electro-chemical background.
- Thorough understanding of statistical methods.
- Good communication and interpersonal skills.
- Sound knowledge of Microsoft Office applications and statistical analysis.
Senior Scientist - Immunoassay
Description:
Technical lead in designing, validating and transferring to production immunoassay-based clinical assays on Epocal's immunoassay platform (card and reader).
Major Activities:
- Lead problem solver in designing, characterizing and optimizing both reagent formatting (antibody selection, buffer formulations, print process) and platform programming (incubation and injection timings, temperature control, algorithm development, iQC development for key immunoassay analytes.
- Organize and perform clinical trials as part of product validation.
- Construct the design history file and device master record.
- Interface with other members of product development team as well as all other resources needed to ensure smooth transfer to production.
Requirements:
- PhD (preferred) or M.Sc. in the physical sciences or engineering disciplines (Physics, Chemistry, Analytical Chemistry, Chemical / Biomedical / Electrical / Systems Engineering) OR in Biochemistry or Biology
- Experience in an industrial setting, working with complex (highly integrated) product devices, preferably medical devices.
- Technical Lead with Project Management responsibilities.
- Exposure to fluidic-based micro-devices or MEMS.
System Support Engineer (US Based)
Description:
The System Support Engineer is a key member of Epocal's Systems Engineering team playing an active role in product deployment and support while working in conjunction with the Sales and Marketing Department. The System Support Engineer supports the Information Technology products related to the epoc® Blood Analysis System and its integration in various hospital environments.
Major Activities:
- Provide IT expertise and troubleshooting with Technical Support of customer issues.
- Support field operations with regard to the Information Technology aspects of the epoc® Blood Analysis System.
- Participate in in-house projects, in support of field personnel, involving new off-the-shelf equipment evaluations, computer and connectivity related issues.
- Train employees on product IT solutions.
- Interact with a wide variety of departments / disciplines, i.e., Engineering, Sales and external customers.
- Provide support for specific customer integration issues at customer sites and provide feedback into system design that helps address integration issues.
- Provide technical advice / recommendations to Epocal's technical and Sales & Marketing staff regarding applications of technology in hospital environments, especially as it relates to Epocal's procedures (device, information technology, wireless connectivity, technology standards and regulations).
- May be required to write "white papers", customer presentations, and deliver in-house training.
Job Requirements:
- Bachelor's degree in Computer, Systems Engineering or related discipline.
- Minimum of three years related experience.
- Knowledge of:
- connectivity and Wi-Fi and Bluetooth communication technologies.
- LAN and WLAN security protocols.
- Database applications.
- Connectivity solutions.
- Intermediate to expert knowledge of Microsoft Windows environments
Desirable skills / competencies:
- Server, Virtual Server, computer and network architecture knowledge
- Java Script
- SQL Service and DB skills
- Medical device knowledge
Description:
The Senior Process Engineer is a key member of the Manufacturing Team playing a key role by providing guidance and advice to solve technical issues related to manufacturing, transfer of new products and processes from R&D to manufacturing, and to execute continuous improvement initiatives. The Senior Process Engineer will provide senior level leadership as a subject matter expert to all levels of the organization.
Epocal is seeking an outstanding individual who possesses a breadth and depth of required technical understanding; from detailed chemical reactions to mechanical engineering. The successful candidate will have an opportunity to work within a dynamic start-up environment with short decision making hierarchy and cross functional interdependence.
Major Activities:
- The Senior Process Engineer will provide high level technical support
for manufacturing processes and procedures, including but not limited to:
i. Design discrepancies.
ii. Equipment repairs and/or changes.
iii. Reasoned, rapid response to process, component, or product quality, yield, or throughput issues.
- The position requires the presentation of expert technical advice
regarding:
i. Monitoring and reporting of manufacturing-related data, including:
• Coordination and evaluation of process, product, equipment, and component validations and verifications (e.g. new product introductions)
• The short & long term reliability of fixed equipment.
• The short & long term reliability of rotating equipment.
ii. In collaboration with other areas, provide feedback on equipment reliability issues, assist in troubleshooting of card manufacturing process, equipment, testing, and procedural issues to minimize downtime; often required within a short response time.
- Provide high level guidance and advice based on strong knowledge of the
relationship of chemical reactions to mechanical engineering to advanced
process control theories:
i. Become Subject Matter Expert for all manufacturing processes.
ii. Use advanced knowledge to get to root cause and propose solutions.
iii. Continuous improvement and enforcement of manufacturing processes and procedures, including implementation of advanced process control strategies.
iv. Generation and modification of manufacturing documentation.
v. Improvement of data collection procedures.
Requirements:
- Masters Degree in Engineering coupled with 10+ years of professional experience.
- Extensive process control experience from chemical or related industry.
- Previous experience with New Product Introduction and Continuous Improvement activities within a manufacturing environment.
- Understanding and facility with statistical methods related to product or process validation and control, gained through both theory and practice, particularly in chemical industries.
- Familiarity with manufacturing operations in regulated industries would be a strong asset.
- Experience within the medical device industry would be an asset.
- Flexibility to respond to a changing and evolving environment.
- Excellent oral and written English communication skills.
Description:
The Senior Mechanical Engineer, will assume the
primary role in leading the development of product and automated
manufacturing equipment providing leadership to a talented
multi-disciplinary team of contributors.
The Senior Mechanical
Engineer will be directly involved in and provide leadership to the design
and development of complex mechanical devices.
Major Activities:
- Project management of multi task work assignments in collaboration with
senior management to achieve strategic business goals.
- Ensure a fast prototyping cycle so new designs can be efficiently evaluated.
- Proactively identify and resolve technical and non-technical issues
- Turn data into knowledge and decisions by relying on a strong working knowledge of statistics.
- As some resources are shared, and negotiation of priorities with
parallel projects is likely, a collaborative nature is required:
i. Apply judgment to prioritize efforts and resolve issues in a timely fashion.
ii. Collaborate with cross functional teams to transfer new products to manufacturing or resolve product quality issues. - Work according to established company policies and regulatory requirements.
Requirements:
- Demonstrate ability to perform well in very dynamic work environment and provide leadership role to other members of the work team. It is essential to grasp the multi-disciplinary nature of Epocal’s products, processes and activities and develop good understanding of requirements related to the products and production equipment.
- Understand how the chemistry in the devices work.
- Understand the manufacturing processes.
- Use this knowledge to get to root cause and propose new designs and solutions.
- Continuously evaluate new technological solutions.
- Degree in Mechanical Engineering supported with minimum of 15 years of related work experience.
- Experience in design and development of high speed automated production equipment.
- Proven record of project management.
- Knowledge of computer aided design tools (preferably SolidWorks)
- Familiarity with PLC programs and image processing systems.
- Familiarity with Quality Management System.
- Demonstrate expertise and strength in automation .
- Experience in technology deployment into manufacturing and post-transfer support.
- Ability to quickly assess and diagnose complex automation problems and implement effective solutions.
- Ability to manage rapid change in processes and equipment.
- Effective communication and organizational skills and must be able to prepare competent documentation.
- High level of analytical skills related to design of electro/mechanical devices.
Description:
The Accounting Analyst is responsible for the general ledger, including accounts receivable, sales tax, warranty reserve, account reconciliations, and financial analysis.
Major Activities:
- Prepares weekly accounts receivable, including receivable inquiry and cash application.
- Performs sales tax assessments.
- Performs customer credit checks.
- Prepares monthly, quarterly, and annual journal entries to general ledger.
- Completes monthly financial and variance analysis.
- Assists with year-end audit and tax reporting.
- May be asked to complete ad-hoc analysis, including forecasting, cost analysis etc.
- Frequent interaction with customer service, tax team, banking institutions.
- Repetitive and tedious data entry tasks.
- High level of accuracy is essential
- Ability to juggle and prioritize multiple tasks
- Ability to work independently and solve problems
Requirements:
- Applies knowledge of business, accounting, and financial principles.
- Analyzes and prepares business cases, budgets, reports, forecasts, and variances.
- Ability to manage and operate on-line (lockbox) banking software.
- Advises functional management on financial issues.
- Applies learned skills and knowledge to structured and routine tasks.
- Focus on learning and practicing by doing.
- Makes decisions in consultation with others.
- Works under close supervision and receives regular guidance from others.
- Progress and output is regularly reviewed, and feedback is provided to support training.
- University degree in accounting or finance.
- 0-2 years relevant experience.
- Ability to work effectively in a team environment.
- Computer literate including MS Office (i.e., Word, Excel, PowerPoint, Acrobat, etc.)
- Honesty and integrity.
- Positive, can-do attitude.
- Energetic, dedicated, self-motivated individual.
- Willingness to learn and grow with small company.
- Logical, meticulous, and organized.
- Effective oral and written communications skills.
- Adaptable and willing to take on new tasks and responsibilities.
Description:
The Process Engineer (Card Manufacturing) is responsible to ensure reliable and efficient test card manufacturing operation.
Major Activities:
- Troubleshooting of card manufacturing process, equipment, and procedural issues to minimize downtime.
- Monitoring and reporting of manufacturing-related data and improvement of data collection procedures.
- Coordination and evaluation of process, equipment, and component validations and verifications.
- Supervision of assembly operators, including assignment of their day-to-day tasks.
- Continuous improvement of manufacturing processes and procedures.
- Generation and modification of manufacturing documentation.
- Enforcement of Good Manufacturing Practices.
- Breadth of required technical understanding: from detailed chemical reactions to mechanical engineering.
- Dynamic “start-up” environment with extremely short decision-making hierarchy and cross-functional interdependence.
- Shiftwork, including overnight shifts.
Requirements:
- Previous positions in a manufacturing company, with demonstrated experience in process sustaining and continuous improvement practices.
- Understanding and facility with statistical methods related to product or process validation, gained through both theory and practice.
- Familiarity with manufacturing operations in regulated industries would be an asset.
- Honest, open manner of work.
- Positive, “can do” attitude toward challenging problems.
- Focus on learning and practicing by doing.
- Ability to shut out distractions and focus on priorities.
- Good communicator.
- Requires minimal supervision to achieve goals.
Description:
The Chemical Preparation Technician is responsible for the preparation of sensor print mixes, stock solutions, or other chemical mixtures.
Major Activities:
- Accurate and timely preparation of chemical mixes for sensor and test card assembly processes.
- Interact with card assembly personnel to ensure adequate supply of chemical mixtures throughout a shift. Follow written procedures for each mixture, and maintain appropriate records for each activity.
- Carry out routine maintenance and basic troubleshooting of chemprep lab equipment, and record these activities in maintenance logs.
- Maintain chemprep room cleanliness and organization.
- Track inventory of chemprep lab supplies and initiate orders when necessary.
- Participate in chemprep process and equipment improvement efforts when necessary.
- Cross training with other areas of card manufacturing may be required in the future.
- Routine nature of chemical preparations.
- Despite routine nature, attention to detail is still required.
- Shiftwork, including overnight shifts.
Requirements:
- chemical lab experience is required.
- Proven ability to work effectively in a team environment while satisfying personal responsibilities
- Demonstration of successful on-the-job training
- Experience in a regulated industry is an asset.
- Honesty and Integrity.
- Satisfaction derived from solid completion of tasks.
- Insistence on clearly defined goals for work.
- Ready to speak up about concerns.
- Requires minimal supervision to achieve goals.
Description:
Design, development and document software for Epocal’s in-house and product software applications (primarily .NET environment).
Major Activities:
- Design, develop, implement and document application software for Epocal’s PC / Pocket PC based diagnostic testing products.
- Uses applicable technologies that include: C#, .NET, T-SQL, Windows Form, OO, SQL Server 2003, 2005 database.
- Mature knowledge in developing software applications in multi-threading, windows based networked environments and in utilizing network communications protocols. [Typically not as advanced for less senior positions].
- Full autonomy and accountability for project’s deliverables. [Typically not as advanced for less senior positions].
- Project manages at least medium scaled projects, responsible for technical aspects and co-ordination of varied Epocal and outside interfaces. [Typically not as advanced for less senior positions].
- Provide guidance to less experienced staff. [Typically not as advanced for less senior positions].
- Work outputs can be trusted as accurate and sound without detailed review. [Typically not as advanced for less senior positions].
- Recommends and develops software architecture and high level design. [Typically not as advanced for less senior positions].
- Requires a degree of independent requirements analysis and liaison with internal and external sources.
- FDA/GMP/ISO - highly regulated operating environment.
Requirements:
- Bachelors’ degree in software related engineering or related discipline, 1-5 years related experience.
- Mature software engineering skills with knowledge of multiple technologies. [Typically not as advanced for less senior positions].
- Well organized work habits.
- Good analytical skills.
- Good people skills.
Interested applicants should submit resume and references in confidence to:
Epocal Career Opportunities:
Via email to: humanresources@epocal.com
Via fax with cover sheet to: (613) 738-6195
Via mail to:
Epocal Inc.
Human Resources
2060 Walkley Road
Ottawa, ON
K1G 3P5
Canada
