As a member of our Science & Technology team, you will be responsible to drive on-target product development by providing technical leadership and expertise to TMI’s New Product Development teams. Proactively investigate and implement process improvement across the product development group. Coach and mentor engineering and technical staff.
Internal Analysis Capabilities and Best Practices
- Support intra and inter departmental decision making, e.g. by conducting research, providing statistical data and reports, evaluating laboratory and simulation results, etc.
- Drive imaginative, thorough, and practicable solutions to complex technical problems, i.e., through in-depth evaluation and analysis of various factors, e.g., by exploring the subject area, defining the scope, selecting problems for investigation, and developing novel concepts and approaches.
- Develop standard engineering practices, i.e., by researching and implementing new tools and techniques.
- Create excellent product solutions by working cross-functionally.
- Resolve problems in areas of considerable scope and complexity.
- Ensure reliable and sound process start-ups by performing design reviews and re-validation assessments.
- Generate intellectual property valuable to the Company for new technologies.
- Deliver inventions, new designs, or techniques that are of material significance in the solution of important problems
NPD Process Development
- Ensure NPD process suit their purpose and are continuously improved (simplified, efficient, compliant), i.e., from design input through to design output and design transfer.
- Develop internal Design of Experiments (DOE) methodology and overall approach for exploring device design space and process windows for the various programs.
- Create test methods capable of representing patient populations along with repeatable data collection using guidance documents.
- Determines direction and adequacy of designs and test results and recommends changes.
- Develop test plans to prove concepts.
- Obtain desired results by exercising judgment when selecting appropriate methods and techniques.
- Provide technical expertise to the organization in the application of advanced theories, concepts, principles, and processes.
- Review and approve engineering work product of other engineers including documents, drawings, and specifications.
- Stay current on new methods, techniques, tools, etc. to sustain technical expertise.
- Lead and/or participate in cross functional teams to communicate project deliverables across multiple project phases.
- Identify and prioritize work activities as necessary to achieve project goals within set timelines.
- Provide design leadership and support to device projects and teams.
- Provide technical guidance based on data analysis.
- Mentor and coach engineering and technical staff
Product Design and Development
- Develop medical devices including system-level products with mechanical, electrical, software, and firmware design aspects.
- Ensure essential platform design robustness, i.e., by ensuring designs are based on agreed Design for Manufacturing, Assembly and Testing principles (DFM and DFA)
- Design robust products and technologies based on a thorough understanding of underlying physics.
- Drive thorough, practical, and efficient application of regulations and standards.
- Develop final specifications with inputs from cross functional teams.
- Complete product testing as required, i.e., by coordinating internal and external testing logistics.
- Gather data that supports design verification and validation by working collectively with Product Development, Manufacturing Engineering, Regulatory and Quality
Health and Safety
- Comply with relevant health and safety legislation, including the Workplace Safety and Insurance Act, the Occupational Health and Safety Act, etc.
- Degree in Mechanical Engineering or a related field of study
- 10 years of experience in medical device development (mechanical, and systems with electronics - hardware, and firmware)
- Maintain P. Eng. and remain in good standing with Professional Engineers Ontario
- Understanding of Design controls within in a medical device QMS, e.g., ISO13485
- Medical device industry knowledge including regulatory requirements, e.g., FDA 510k.
- Six Sigma/Design for Six Sigma
- Ability to effectively tailor communications based on circumstance, i.e., nature of message, audience, etc.
- Proven technical writing skills to develop protocols and reports.
- Ability to prioritize and work to completion on a variety of projects and tasks.
- Ability to work effectively as a cross functional team member.
- Experience working effectively with external customers.
- Experience utilizing computer aided design (CAD) to develop medical devices (Solidworks preferred)
- Experience with computer aided engineering tools including Finite Element Analysis, Computational Fluid Dynamics, and Tolerance Analysis
- Mastery of theoretical and practical engineering fundamentals and experimental engineering techniques
- Ability to work effectively under minimal supervision
If you interested in this employment opportunity, please apply through LinkedIn
At the applicant's request, TMI will make accommodation to its recruitment process to meet the needs of applicants with disabilities.
Please send your résumé only once per position.
Résumés will be accepted throughout the process, but only candidates selected for interviews will be contacted.
TMI is an equal opportunity employer.
We thank all applicants in advance for their interest in joining our team.