Associate Mechanical Engineer/Developer

Job Summary
Design and development of new products, accessories and spare parts, and engineering support of current products related to manufacturing of suction & oxygen therapy medical devices (flowmeters, suction regulators) and patient room furniture (overbed tables, mother baby equipment, casegoods, carts).

Core Competencies

1. Self-motivated and have a hands-on approach
2. Strong mechanical aptitude - must pass the Amico Patient Care Mechanical Aptitude Test (APC-MAT) with a score of 90% or above
3. Strong oral and written communication skills
4. Able to work independently within a collaborative multi-disciplinary team environment with limited supervision
5. Able to effectively manage multiple priorities and meet established deadlines; results-focus
6. Sound decision making and judgment capabilities
7. Able to adapt to changes quickly in a fast-paced work environment
8. Hands-on experience of working in an ISO 13485 or ISO 9001 manufacturing/factory setting
9. Design and development experience in medical furniture and suction & oxygen therapy medical devices
10. Working knowledge of BIFMA HCF8.1, ANSI/BIFMA X5.9 and ASTM F2057 furniture standards
11. Working knowledge of ISO 15001, ISO 15002 flowmeter standards, and ISO 10079-3, ISO 10079-4 suction regulator standards
12. Industry working experience with SolidWorks 2023 SP5.0 or above

Job Duties & Responsibilities

1. Be part of a product development team working on support of current products and new product
2. Design new parts, components, or assemblies for use in new or current products
3. Improve design of existing parts to improve manufacturability, reliability or reduce cost where required
4. Conduct tolerance stack-up analysis of designs and failure mode and effects analysis (FMEA) of designs and processes as part of risk management where required
5. Process engineering changes according to established procedures
6. Create and maintain technical/regulatory documentation (design master records & design history files) for new products and design changes
7. Develop verification & validation plans and conduct product verification/validation testing
8. Participate in design reviews for new parts and products when required
9. Build and test prototypes to ensure all essential design requirements are met
10. Identify, analyze and correct product or process issues
11. Design production jigs and fixtures
12. Source and qualify vendors for new part designs and current product parts where required

Education & Experience Requirements

1. University Degree in Mechanical or Electro-Mechanical Engineering, P.Eng. status an asset
2. 1-3 years of proven working experience in mechanical design
3. Must be enrolled in the Engineering-In-Training (EIT) Program from Professional Engineers Ontario (PEO) if not a P.Eng.
4. Proven experience in designing mechanical components or assemblies from concept to manufacturing
5. Good understanding of Design and Process FMEA an asset
6. Working knowledge of drafting standards and GD&T an asset
7. Working knowledge of plastic injection moulding an asset
8. Working knowledge of jig & fixture design an asset
9. Basic understanding of electronics an asset
10. SolidWorks certification