Manufacturing Process Engineer

Department: Manufacturing Operations

Location: Mississauga (On-site)

Compensation: CA$78K – CA$100K

Employment Type: FullTime

About us

Trexo Robotics is enabling mobility by building powered wearable robots. Our first product is a robot for children with movement disorders such as Cerebral Palsy, and it allows kids to walk, in many cases, for the first time in their lives. The device is currently being used by hundreds of families and the best hospitals across North America.

We are constantly working towards building mobility solutions for all. At Trexo Robotics, you will find a flat organization where you can work with highly optimistic, low ego, and exceptionally talented individuals who look forward to solving hard problems.

About the job

We are currently hiring for a talented Manufacturing Process Engineer to join our team. This role will work closely with the Engineering team, the internal Production team and our Manufacturing partners to ensure product designs are ready for manufacturing and assembly and that are processes produce designs per the specifications and meet regulatory requirements.

This position will be in-person from our office in Mississauga.

About you

If you are someone who wants to work in a small team to solve a big problem, and you have a passion for manufacturing along with an engineering and operations mindset, then this opportunity might be perfect for you.

The idea of revolutionizing multiple industries excites you, and you have the ability to handle multiple tasks simultaneously with excellent task management skills. You pay attention to detail and enjoy asking "why" multiple times until you understand something from its core principles.

Ideally, you also have a successful track record working in a manufacturing team in a small to midsize company during a growth phase.

What you'll do

• Work cross-functionally with various teams including engineering, supply chain, and manufacturing on developing and implementing process development procedures that are compliant to FDA, ISO, GMP.

• Conduct and maintain process risk assessment activities (including PFMEA’s) in order to identify critical process parameters and develop appropriate control plans to mitigate risks.

• Generate technical documentation, including but not limited to drawings, and assembly instructions.

• Support design transfer and processes from R&D into a cGMP environment. (EVT, DVT and PVT).

• Develop Validation Plans, plan and execute process validation (IQ, OQ, PQ) activities to demonstrate that the manufacturing processes of Trexo devices meet specifications and quality standards.

• Develop and implement robust incoming inspection, in-line testing methodologies and quality control measures to ensure product reliability and performance and participate in NCRs, CAPAs, deviations and trend analysis.

• Work with suppliers to ensure the quality and reliability of parts and materials while approving new, and maintaining existing suppliers in our approved supplier list.

• Create, Review and Implement changes through the Change Management Processes.

Required Skills

• Minimum 3 years working experience in medical device industries.

• Extensive experience with manufacturing and assembly processes for mechanical and electrical parts.

• Experience in process validation (IQ, OQ & PQ), process FMEA and project management.

• Hands-on experience with Lean/Six Sigma tools, such as value-stream mapping, fishbone diagrams, Pareto diagrams, 5S, Kanban, or Standard Work.

• Extensive experience with Solidworks.

• Great organizational and time management skills.

• Strong root cause analysis / Problem solving skills.

• Clear, concise, and thorough documentation.

• Detail-orientated, patient, and diligent.

• Excellent verbal and written communication skills.

Nice to Have

• Experience or interest in Robotics.

• Expertise in Geometric Dimensioning and Tolerancing

• Knowledge of or experience with ISO 13485 and 21 CFR 820.

• Service experience - service documentation, training others, working with 3rd party service providers

Work Authorization: Please note that we are unable to provide visa sponsorship or support work authorization applications. We can only consider candidates who already have the legal right to work in the location they are applying for.

AI in Recruitment: At Trexo Robotics, we use artificial intelligence (AI) tools to support our recruitment process. AI helps with tasks like resume screening, drafting job descriptions, creating interview questions, and occasionally sourcing candidates. Final hiring decisions are always made by our team. Our goal is to use AI responsibly to streamline administrative tasks, improve candidate experience, and maintain fair, unbiased hiring practices aligned with industry standards.