The New Product Transfer (NPT) Lead supports instrument product design transfer projects, involving interaction with various departments and company sites. Reporting to Director of Quality, the NPT Lead is responsible for successful delivery of technology transfer activities, to ensure robust and reproducible manufacturing of newly developed products and existing product improvements.
Position Responsibilities/Essential Functions
- Lead cross-functional NPT team members from quality, manufacturing, service, R+D, logistics; coordinate all design transfer activities for new and improved products.
- Develop Manufacturing Plan – mapping out the entire process workflow, work instructions, V&V SOPs, and assembly tools/equipment/test jigs required to manufacture an end product according to its Device Master Record
- Develop design verification and validation test plans for new and/or improved products, and monitor/audit execution to ensure compliance.
- Develop NPT tools and processes for instrumentation development
- Manage Instrument Bill Of Materials and transfer to production MRP
- Co-ordinate transition training activities from R+D to manufacturing and service
- Co-ordinate and lead technical reviews for Design For Manufacturing (DFM), Design For Assembly (DFA), and Design For Serviceability (DFS)
- Coordinate pFMEA risk management meetings and follow-through on risk mitigation strategies/action items
- Independent technical support and decision making for methods with complexity.
- Assist with the planning of new product and process developments and input knowledge of existing products and processes.
- Assist with process improvement initiatives related product development to ensure robust processes are transferred to Manufacturing.
Minimum Job Requirements:
- BASc in Engineering or related discipline, with 5 years of related industry experience (mass spectrometry or cytometry preferred).
- Experience in manufacturing, service, product transfer and/or product support functions.
- Good understanding of ISO 13485 standard in general, with focus on Design Control
- Demonstrated ability and proficiency in the development and execution of design verification and validation, equipment qualification protocols (IQ, OQ, and PQ), process validations, software validations and other validation lifecycle documents.
- Experience in preparing manufacturing documents including SOPs, specification sheets and worksheets, with good working knowledge of manufacturing-related drawings, machine specifications, and required test equipment/fixtures
- Ability to read, analyze, and interpret common technical reports, technical procedures, validation protocols and reports, operating instructions, and regulatory requirements.
- Demonstrated ability for technical creativity, problem solving skills, collaboration with other departments, and ability to manage multiple projects or assignments.
- Ability to present and communicate (oral and written) information in a clear manner.
- Proficiency with Microsoft Office, including Word, Excel, PowerPoint, and Visio.
- Experience with DFM, DFA, and DFS considered an asset.
- Travel required - less than 10%.
The Company is committed to providing an inclusive and barrier free recruitment process to applicants with accessibility needs in accordance with the Ontario Human Rights Code and the Accessibility for Ontarians with Disabilities Act (AODA). If you require an accommodation during this process, please inform The Company of your requirements. We are an equal opportunity employer.