Sustaining Engineer

Type of Position:
Full Time

Location:

Kitchener HQ – In office presence required 4-days per week Benefits: RRSP with employer match, health benefits (effective day-1!), wellness benefit, learning & development opportunities, paid vacation, personal days, and sick days Salary Range: $75k - $90k CAD
* Individual placement within the salary range will be based on experience, skills, market data, and internal equity considerations The Company Intellijoint Surgical develops effective and easy-to-use products to enhance surgeons’ care and patients’ lives.

Today, Intellijoint technology lives in the operating room, helping surgeons improve implant positioning during hip and knee replacement surgeries.

Our technology has been used in over 80,000 surgeries.

We are seeking a Sustaining Engineer to join our growing Business Operations team to help bring innovative technologies to the market. The Position Reporting to the Sr.

Director, Business Operations, the Sustaining Engineer will own sustaining activities for Intellijoint’s commercialized medical device products, ensuring ongoing compliance with regulatory, quality and safety requirements. In this role, the Sustaining Engineer will partner cross-functionally with R&D, Quality, Regulatory, PMO, Operations and Supply Chain to identify and resolve product and process issues. This role is ideal for someone who:
Has strong engineering skills, with experience in mechanical, and software design for medical devices. Is analytical, methodical and able to analyze and interpret technical data. Is collaborative, with strong communication skills, to work with various departments and stakeholders. Main Duties:
Sustaining:
Work directly with suppliers to resolve technical issues, manage product and component obsolescence, and support supplier quality improvements. Analyze data from product complaints, field feedback, and post-market surveillance to identify trends and systemic issues. Conduct supplier performance analysis and bridge field data with supplier data to drive root cause investigations and corrective actions. Ownership of calibration for Operations-owned assets.

Performing equipment qualifications (IQ/OQ/PQ). Partner with Quality Assurance to address CAPAs, NCRs, and audit findings, ensuring timely and effective resolution. Technical Design & Documentation:
Evaluate and approve technical changes, including reviewing and assessing drawings, specifications, and documentation to ensure design integrity and product equivalence. Lead or support design change activities with suppliers, including technical risk assessments and validation requirements. Facilitate the design transfer of the product from R&D to Operations.

Support drafting work instructions and production risk reports. Contribute to the continuous improvement of sustaining processes, documentation, and best practices. ​​​​​​​Project Management:
Prioritize and coordinate resources to drive the timely resolution of issues and execution of improvement initiatives. Plan, prioritize, and execute sustaining engineering projects, managing timelines, budgets and resources to meet business objectives. Act as the primary point of contact for internal teams and external partners (suppliers, distributors), ensuring alignment on project objectives and timelines. While adhering to internal governance processes, regulatory requirements, and quality standards throughout execution.

New Market Expansion:
Support product expansions into new geographic regions by assessing regional operational, regulatory and engineering requirements. Apply existing internal processes to enable efficient and compliant entry into new markets. Skills and Experience to Enable Success:
Bachelor’s degree in Engineering (Mechanical, Biomedical or related field) 3-7 years of experience in medical device, life sciences, or regulated manufacturing environment Experience supporting commercialized products in sustaining, manufacturing, or operations engineering role Strong understanding of regulatory and quality requirements for medical devices (e.g.

ISO 13485, FDA, MDR) Experience working directly with suppliers on technical issues, component…