Sustaining Engineer

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.

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 ISO 13485, FDA, MDR)

• Experience working directly with suppliers on technical issues, component changes, and obsolescence management.

• Ability to read and interpret engineering drawings, specifications, and change documentation

• Demonstrated experience using data to identify trends and drive corrective and preventative actions.

• Comfortable working in a highly cross-functional & fast-paced environment and managing multiple priorities.

• Ability to influence without direct authority in a cross-functional environment.

Why Join Us?

• It is unrealistic for us to believe we will find someone who fits this position 100%

• Strong support toward career development and growth

• Work with innovative products that can improve surgical outcomes and enhance patients’ quality of life

• Be ready to innovate!

• Work alongside a highly talented and driven group of team members and colleagues organization wide

• Work in an environment with high transparency and collaboration, along with lots of fun and social activities

• Be ok with change and share in our excitement as we scale

• Flexibility so that you can do your best both at work and outside of it