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

Manufacturing Engineer

Application Form