We are seeking a Manufacturing Engineer to support the transition from product design into early manufacturing and supplier production. This role is highly hands-on and execution-focused, reporting to the Senior Mechanical Designer and working closely with cross-functional partners to ensure the product is manufacturable, compliant, and ready for scale.

The ideal candidate has experience supporting manufacturing process development in a regulated environment and thrives in a startup or scale-up setting where processes are still being built.

This role may support the setup of limited, well-documented, and regulatory-compliant internal manufacturing activities at EERS, intended for pilot builds, verification runs, and early production support prior to full external scale-up. The role will also work closely with EERS’s internal prototyping team to transition prototype builds into documented, repeatable, and regulatorily compliant manufacturing processes

Responsibilities

Manufacturing Process Support & Design Transfer

• Support the transition from design to manufacturing, including participation in DFM/DFA reviews
• Collaborate with the internal prototyping team to evolve prototype assemblies into manufacturable designs and documented processes
• Assist in developing and documenting manufacturing processes for a Class II medical device
• Create and maintain manufacturing documentation such as:
• Work instructions
• Process flows
• Manufacturing BOMs and routings
• Support pilot builds and early production runs, including hands-on involvement during assembly and testing
• Support the development of limited internal manufacturing capabilities at EERS, including documented assembly processes in alignment with FDA QSR and ISO 13485 expectations

Supplier & Contract Manufacturer Support

• Support day-to-day technical interactions with contract manufacturers and key suppliers
• Participate in trial and pilot builds at supplier sites
• Help track and resolve manufacturing issues, working closely with Quality, R&D, and Supply Chain
• Support supplier onboarding and basic technical assessments

Quality & Regulatory Support

• Ensure manufacturing activities align with:
• FDA 21 CFR 820 (QSR)
• ISO 13485 requirements
• Support:
• Process validation activities (IQ/OQ/PQ)
• Nonconformance investigations and corrective actions
• Change control and ECO implementation
• Assist during internal and external audits as needed

Production & Continuous Improvement

• Troubleshoot manufacturing and assembly issues using structured problem-solving approaches
• Support improvements in yield, quality, and cycle time
• Assist with documentation updates as designs or processes evolve

Travel

• Frequent travel required to support suppliers and contract manufacturers
• Expected travel locations include:
• United States
• Asia
• Ontario
• Travel frequency will vary depending on build phases, supplier qualification, and manufacturing readiness activities

Desired Profile

Qualifications

• Bachelor’s degree in Mechanical Engineering, Manufacturing Engineering, or a related field
• 3–6 years of experience in manufacturing , supply chain or process engineering
• Experience working in a regulated environment (medical devices strongly preferred)
• Exposure to:
• Design transfer or early manufacturing builds
• Manufacturing documentation and work instructions
• Supplier or contract manufacturer interaction
• Strong communication skills and ability to work effectively on site and with external partners
• Willingness to travel internationally as needed

Nice to Have

• Ability to communicate in French and English
• Experience supporting early-stage or first-product launches
• Familiarity with Class II medical devices and 510(k) manufacturing expectations
• Hands-on experience with electromechanical assembly or precision manufacturing processes
• Exposure to process validation activities or supplier audits
• Lean, Six Sigma, or continuous improvement training