R&D Systems & Process Architect (Waterloo) - Canada
Expected Travel: 20%
Employment Type: Regular Full-time
- We are looking for a Systems & Process Architect to join our R&D team to provide expertise in the development of our company’s global R&D business systems and processes.
- As a Systems & Process Architect, you will work closely with the development team to oversee the design, implementation, and maintenance of our company’s product lifecycle management (PLM) system, engineering change management system, new production introduction process among others.
- Specifically, we are seeking someone with a strong background in developing design and change control systems for optoelectrical systems used in both regulated markets (e.g. medical) and commercial markets.
- The successful candidate is highly organized, results-driven and capable of streamlining systems and processes such that design control is fast, efficient and accurate.
Scope of Responsibilities:
- Develop business solutions for R&D systems and processes, working with business process owners, department heads, functional groups, IT, and others.
- Lead the selection of appropriate R&D IT systems that are cost effective and meet global corporate needs.
- Design the technical architecture for these solutions in a manner that allows ease of use and quick adoption by the user in all the business groups involved.
- An aptitude for utilizing out of the box solutions as much as possible is desired.
- Provide functional PLM expertise in areas of Program Management, CAD management, BOM management, Change Management, Quality Management, Process Management, Production Planning, and Execution.
- Work with Business teams to define processes and requirements within the scope of their business needs.
- Collaborate with IT to ensure that all data has the required levels of security and protection for our company’s business information.
- Partner with IT providing technical expertise on the deployed solutions to ensure that downtime from process issues is minimized.
- Oversee the development and delivery of training programs across the organization for the R&D business systems.
- Manage a small development team that facilitates the implementation and maintenance of the systems.
- Our company is committed to achieving excellence in our Quality activities, which is dependent upon the processes, practices, and employees of our company.
- Our objective is to maintain a Quality Management System in compliance with ISO 9001, ISO 13485, the US FDA Quality System Regulation as well as any additional regulatory requirements of the markets in which our products are sold.
- Employees of our company are instrumental to our compliance efforts and are required to understand and comply with the QMS.
- Accountable for designing, implementing and maintaining all design control procedures for company’s product development projects
Education and Professional Qualifications:
- Bachelor of Computer Science or Engineering or equivalent
- 8 years minimum experience in Business Process Consulting, problem definition, and/or Architecture/Design/Detailing of Processes.
- 5+ years of experience in PLM Implementation & Maintenance Projects
- Familiarity with company business systems (e.g. ERP – Epicor, OfficeLine; ALM – Polarion, QMS – TLM)
- Knowledge and Experience of PLM activities such as but not limited to:
- Manufacturing Change and BOM Management
- MCAD and ECAD Integrations
- MRP/ERP Integration
- Requirements Management
- Issue Management
- Supplier Relationship and Vendor Management
- Regulatory Compliance, e.g. RoHS
- Experience in development, configuration, solutions evaluation, validation and deployment of IT systems
- Analytical and Communication skills
- Experience with project management and business system change control
Desired Characteristics/Additional Assets:
- Professional Engineer
- Knowledge of ISO 13485 and FDA Medical Device Standards
- Knowledge of ISO 14971 Medical Device Risk Management