Manufacturing Process Engineer

Manufacturing Process Engineer

• Full-time, permanent position
• Pay Rate : $80K - $90K
• Trenton, ON - Onsite

We at Raise are hiring for one

of our key clients in the Life Sciences industry. After establishing themselves

as an industry leader, our client’s team is expanding to meet rising demand.

They’re looking for skilled technical professionals like you to help complete

meaningful and impactful projects. This is a role where you can learn and grow

alongside an experienced team. If you want a job where you can build skills

with an industry leader, this could be it.

They’re hiring right now; if you’re interested, apply today for your chance to join a great

place to work.

Position Title : Manufacturing Process Engineer (PE)

Reports to : Manufacturing Engineering Manager

Main functions :

The primary function is to ensure the operation's performance integrity and compliance to customer expectations of all products manufactured at the company.

The Process Engineer improves overall efficiency, quality, productivity, and cost of existing company processes, as well as being an integral part of the launch of new processes.

The Process Engineer will prioritize their duties according to the SQDC mantra (Safety, Quality, Delivery and Cost) and will contribute to the safety of the team members by ensuring that equipment / processes are engineered to comply with all relevant safety and ergonomic standards.

Duties :

• Responsible for supporting all technical aspects of extrusion and molding production processes, which includes the definition, management, and continuous improvement of tooling, equipment and fixtures.
• Will define the production process with enough detail that the production team may consistently meet the customer expectations and quality standards.
• Will develop the process to meet the short and long-term needs of the customer in terms of quantity and delivery.
• Shall use the latest methods of GMP to continually improve throughput and process capability.
• Process Engineer will use the following Engineering disciplines : Process Flow and Process Flow Analysis, Tooling Planning, Acquisition and Maintenance;

PFMEA to establish process risk of failure

• Develop core process standards and drive toward process optimization
• Develop a plan to improve core process including making them faster and more reliable.
• Participate in OEE and Capacity Improvement Teams. Conduct trials in support of process improvement.
• Maintain 5S standards alongside the production team.
• Participate in 8D and other problem-solving events. To preserve the outcome of the 8D team, update the process documentation to prevent recurrence.
• Co-ordinate process to build a process that consistently meets customer expectations focusing on Safety, and maximum efficiencies.
• Manufacturing Methods Engineering- New product introduction by developing manufacturing plans with work instructions
• Provide engineering support to production lines through rework instructions, cost reduction and process improvements
• Communicate information in an effective manner to aid in the advancement of a product from Concept Readiness to Implementation Readiness.

This would include analyzing key data from a run and assembling an improvement strategy for the next run.

Ensure evidence of compliance to our internal policy and procedures. Create and maintain tooling and machine drawings in an organized way.

Draft, layout, and specify technical devices, parts, and equipment by providing documentation, detailed instructions, drawings, or specifications to define for others how devices, equipment, or structures are to be manufactured, assembled, modified, maintained, or used.

• Each process within the responsibility of the process engineer should have a continuous improvement plan.
• Troubleshoot process issues and understand the root cause of problems to identify improvement opportunities.
• Provide technical input and direction during capital projects as it relates to machinery or tooling.
• Utilize industry practices such as Lean, Six Sigma, and Project Management methodologies
• Participate in Ergonomics and safety improvement teams.
• Be role models in support of company objectives, policy and procedures and safety guidelines.

Employment and Educational Requirements :

• Embrace high-performance team principles
• BSc in Engineering with experience in new program / systems development.
• Has 2-3 years (min) of relevant professional experience, preferably in the medical device industry and regulatory compliance requirements.
• Experience in Plastics processing
• Process development, safe manufacturing processes, and facility design (AutoCAD preferably SolidWorks 3D)
• Process validation; Installation Qualification (IQ), Operational Qualification (OP), and Product Qualification (PQ)
• Good Manufacturing Practices (GMP), Good Documentation Practices (GDP).
• Microsoft Office; Word, Excel, PowerPoint, Access, and Visio.
• Optimize and troubleshoot systems.
• Minitab Software and Statistical Process Control.

Competency Profile

• Self-motivated, safety motivated, continuous learner, and highly organized with the ability to manage multiple and concurrent priorities.
• Excellent interpersonal skills, professional attitude, and the ability to interact with various individuals and present information effectively to an audience of various technical backgrounds.
• Advanced negotiation skills, analytical, and problem-solving abilities.
• Data driver, customer-oriented, and not reluctant to take the lead.
• Excellent influencing and decision-making abilities.

Results oriented with the ability to balance other business and departmental strategic goals and objectives with their own.

Working conditions :

Office and production floor environment, computer and desk work.

This job description reflects general details necessary to describe the job’s essential functions and the job’s level of knowledge and skill typically required.

The job description should not be considered an all-inclusive listing of work requirements. Individuals may perform other duties as assigned