Job Description

About us

Trexo Robotics (Y Combinator Company) 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 a fast-growing startup with an ever-increasing backlog of orders and are looking for a highly motivated Process Engineer to help us build Trexos faster, better, and consistently. You will be an integral to the success of the company, as you will be responsible for not only designing and optimizing processes but also ensuring that these processes meet the stringent quality and regulatory requirements that apply to medical device manufacturing. Trexos work doesn\xe2\x80\x99t stop with children. 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. This position is in-person.

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\xe2\x80\x99s) in order to identify critical process parameters and develop appropriate control plans to mitigate risks.
• Participate in New Product Introduction (NPI) for devices in concept, prototype, process development, and process verification and validation phases.
• Develop Validation Plans, plan and execute process validation activities to demonstrate that the manufacturing processes of Trexo devices meet specifications and quality standards.
• Identify, procure, install, qualify (IQ, OQ, PQ), and maintain critical manufacturing equipment.
• Assist in improving manufacturing efficiency by leading projects on DFM, DFA, and process improvements.
• Comply with the Health & Safety policies of the company and inform Management of unsafe working conditions.
• Troubleshoot to resolve NCRs that arise during manufacture of current ands new products.
• Support design transfer and processes from R&D into a cGMP environment.
• Identify process improvements and lead activities required for their effective implementation.
• Support studies and scientific documentation for regulatory approval.
• Ensure warehouse and production areas are optimized, clean, and adhere to safety protocols.

Required Skills

• Minimum 3 years working experience with working experience in medical device industries.
• Experience in process validation (IQ, OQ & PQ), process FMEA and project management.
• Knowledge of or experience with ISO 13485 and 21 CFR 820
• Hands-on experience with Lean/Six Sigma tools, such as value-stream mapping, fishbone diagrams, Pareto diagrams, 5S, Kanban, or Standard Work.
• Knowledge of manufacturing processes, fabrication methods and automation.
• 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.

Compensation and Benefits

• Competitive pay and stock options
• Unlimited Vacation policy
• Group benefits plan - including a $1000 Health Care Spending Account
• Office snacks
• Dog-friendly environment