Senior Product Development Engineer, Design & Compliance

Senior Product Development Engineer, Design & Compliance

As a member of the Science and Technology team, you will provide innovative specialist support to New Product Development teams by developing and sharing expertise in Medical Device Design best practices including modelling and simulation. Develop process improvements that optimize the efficiency and effectiveness of the New Product Development process. Ensure designs are developed in full compliance with established Quality Management Systems, standards, and regulations.

Responsibilities Include:

QMS and Regulatory Compliance

• Represent the QMS and ensure all applicable standards, regulations, policies, and procedures are complied with for all new and existing products under development.
• Keep up to date, maintain expertise, and guide cross functional teams with respect to all relevant standards, regulations, policies, and procedures that apply to new and existing products
• Perform the role of expert document reviewer for device specific Design Controls, new or updated New Product Development Procedures, and regulatory documents related to Product Development.
• Ensure thorough, practical, and efficient application of all applicable policies, procedures, regulations and standards by collaborating with all stakeholders including Quality and Regulatory Affairs
• Perform the role of internal SME regarding Product Development Procedures in the support of audits, regulatory clearance, or other compliance related activity.
• Provide Post Market Surveillance and complaint investigation support and guidance
• Develop and maintain relevant product compliance information in easy to access databases (e.g. biocompatibility, materials compliance).

New Product Development

• Actively research, develop and implement best practice engineering capabilities and processes to ensure on-target New Product Development (quality, cost, time to market)
• Perform role of internal SME on all facets of design and engineering; mentor, coach, and lead NPD team members through new, improved, or existing engineering and design approaches
• Ensure involvement at each step of the design and development process for all active New Product Development or Change Projects; provide Quality System and NPD process expertise and guidance to our internal teams
• Perform the role of independent reviewer as part of formal and informal Design Reviews and Risk Management activities
• Define statistical sampling and testing methods required for verification and validation testing and provide measurement analysis support as required.
• Support product development teams by performing predictive engineering analysis, modelling and simulations to support design and development; ensure designs are optimized early in the development process.

Continuous Improvement

• Ensure NPD processes suit their purpose, satisfy all standards and regulations, and are continuously improved (simplified, efficient, compliant), i.e., from design input through to design output and design transfer.
• As an internal SME on NPD process and engineering capability, contribute to product improvement initiatives that seek improve the cost or quality of existing parts and devices.

Health and Safety

• Ensure compliance with relevant health and safety legislation, including the Workplace Safety and Insurance Act, the Occupational Health and Safety Act, etc.

QUALIFICATIONS

• Degree in Engineering (Mechanical, Mechatronic, Systems Engineering) or a related field of study
• 7+ years of progressive experience in medical device development (mechanical, and systems with electronics - hardware, and firmware)
• P.Eng and in good standing with Professional Engineers Ontario
• Knowledge of New Product Development process and Design controls within in a medical device QMS, e.g., ISO13485, FDA 21 CFR Part 820, EU MDR
• Knowledge of medical device regulatory clearance requirements, e.g., US FDA 510k, CE Marking, Health Canada
• Knowledge of essential engineering and product development approaches and standards including but not limited to Risk management per ISO 1497, Usability engineering per ISO 62366 Biological Evaluation per ISO 10993 and ISO 18562 and Medical Electrical Safety Evaluation per IEC 60601
• Knowledge of lean process or Six Sigma methodologies e.g. DMAIC, 5S etc.
• Ability to lead, coach and mentor less experienced staff to raise their capability or knowledge to a new level
• Ability to confidently evaluate the quality, safety, and details of designs while supporting the rapid development of innovative, cost-effective products.
• Experience performing various modelling and simulations including Finite Element Analysis, Computational Fluid Dynamics, and Mathematical Modelling
• Ability to effectively tailor communications based on circumstance, i.e., nature of message, audience, etc.
• Experience with verification and validation test design and modern testing methodologies, techniques, and tools; experience testing software an asset.
• Proven technical writing skills to develop protocols and reports.
• Ability to prioritize and work to completion on a variety of projects and tasks simultaneously.
• Ability to work effectively as a cross functional team member.
• Experience utilizing computer aided design (CAD) to develop medical devices (Solidworks (mechanical) and Altium (electronics) preferred)
• Experience developing firmware and/or software for medical devices an asset

At an applicant’s request, TMI will make accommodation to its recruitment process to meet the needs of applicants with disabilities.

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