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
