Senior Mechanical Product Design Engineering Specialist
Description
SENIOR MECHANICAL PRODUCT DESIGN ENGINEERING SPECIALIST
JOB PURPOSE
Deliver on complex and/or multiple innovative medical device designs that provide exceptional value to our patients. Demonstrate expert proficiency with the tools and techniques of medical device design while mentoring less experienced engineers. Influence cross functional teams to deliver new product development projects on plan, within target costs, and that meet or exceed our expectations for quality and innovation.
RESPONSIBILITIES INCLUDE
DESIGN DEVELOPMENT & TESTING
Design efficient and effective mechanical solutions for injection molded medical devices
Brainstorm, build and test concepts to evaluate design ideas quickly and effectively
Conduct analyses to ensure robustness of engineering designs
Lead and contribute to design reviews, using expertise to enhance outcomes and ensure robust designs
Create detailed engineering design documentation including requirements, risk analysis, engineering drawings, and design verification and validation documentation
Act as design responsible engineer (DRE) and as a mentor to less experienced engineers to improve their capability and ensure high-quality work products
Develop and maintain internal and external networks that can be leveraged to advance product development capabilities
DEVELOPMENT PROCESS
Lead and/or advise on multiple different invention disclosures including for new technologies or systems
Lead and/or advise on development of multiple project plans and/or where planning expertise is required to address deep uncertainty or new areas of development
Lead continuous improvement teams and deliver on continuous improvement initiatives that improve aspects of the new product development process
Initiate lessons learned processes at points during the product development process in order to capture opportunities for improvement
COLLABORATION
Collaboration with the Research and Innovation team to transfer product ideas into the concept development phase of product development
Collaborate with the Marketing and Sales department to capture the voice of the customer and translate into engineering requirements.
Collaborate with Manufacturing Engineering, Quality Assurance and suppliers to align objectives and drive projects forward
REGULATORY & POLICY
Deliver development of complicated products and/or systems to achieve regulatory clearance and policy compliance
Identify opportunities for improvement to regulatory related activities to optimize product development and improve effectiveness
HEALTH & SAFETY
Comply with relevant health and safety legislation, including the Workplace Safety and Insurance Act, the Occupational Health and Safety Act, etc.
Identify areas for improvement with regards to Health and Safety within product development
QUALIFICATIONS
Degree in Engineering (Mechanical, Mechatronic, Biomedical) or a related field of study
10-15 years of product development and design experience
Experience designing and developing injection moulded parts and devices
Experience working in a regulated industry an asset, e.g. medical device, pharmaceutical or aerospace
CAD (Parts, Assemblies, Drawings, PDM, etc.)
Analysis skills (Risk, Tolerances, Statistical, Root Cause, etc.)
Modelling and Simulation (FEA, CFD, Mathematical, etc.)
Design Verification and Validation (Test Design, Functional, Usability, Compliance, etc.)
Design for Manufacture (molding, automated assembly, packaging, etc.)
Prototyping (3D Printing, Machining, etc.)
Leadership and Mentoring skills
At an applicant’s request, TMI will make accommodation to its recruitment process to meet the needs of applicants with disabilities.