Process Development Engineering Position
Job Description Summary: We are seeking a skilled Process Development Engineer to play a key role in our new product development projects. The successful candidate will be responsible for the design, development, implementation, and validation of manufacturing processes, test methods, and equipment.
-----------------------------------
Main Responsibilities:
* Develop and implement effective manufacturing processes for new products.
* Collaborate with cross-functional teams to ensure project success and timely completion.
* Communicate with suppliers to determine product process and equipment specifications.
* Supervise technicians, engineering interns, or associate engineers to achieve optimal results.
* Document process development including manufacturing procedures, protocols, and reports.
* Stay up-to-date with product design, manufacture, and assembly techniques to drive innovation.
* Evaluate resource requirements and workload assignments for efficient production times.
* Train operations and quality assurance staff on new design and process development and test methods.
* Lead the evaluation of internal manufacturing sites, suppliers, and contract manufacturers for site selection.
* Participate as a subject matter expert and/or lead design and technology transfers to manufacturing.
-----------------------------------
About You:
* A Bachelor's degree in an engineering discipline is required.
* At least 4 years of industrial experience in process development, preferably in medical device or regulated FDA/QSR and ISO environments.
* Hands-on technical skills with knowledge of cGMP and GLP principles.
* Working knowledge of Design of Experiments (DOE) and other statistical methods.
* Strong written, communication, and interpersonal skills to lead cross-functional teams.
* Ability to analyze data, interpret results, and write clear reports.
* Project management skills to create and execute plans.
* Basic tooling, design, and drafting knowledge.
* Training in Six Sigma or Design for Six Sigma.
* Experience in design and technology transfers.
* Process validation experience (IQ, OQ, PQ) is highly valued.
* PMO certification is an asset.