Process Engineering Manager

Baylis Medical Company is a leading developer, manufacturer and supplier of high-technology medical devices for cardiology, radiology and spine products. We require an experienced professional to occupy the position of Process Engineering Manager at our office in Mississauga, Ontario.

Baylis Medical products are marketed in over 65 countries. Our goal is to conceive, develop, manufacture, and sell state-of-the-art medical products that will improve the lives of people around the world. To assist us in realizing our goal, Baylis Medical adheres to four main guiding principles: Technological Leadership, Employee Development, Customer Service and Corporate Social Responsibility.

The Process Engineering Manager will manage the process engineering department staff and projects. The candidate will be accountable for the planning and completion of process development projects, including the design and development of manufacturing processes, documentation, and equipment to successfully implement new and changed products into manufacturing

• Setting the vision, goals and objectives of the department.
• Delivering production processes that are appropriate for the manufacturing environment, and that meet manufacturing objectives.
• Assigning, reviewing and evaluating process engineering project work.
• Making decisions concerning selection, training, rating, discipline and remuneration of staff.
• Developing and managing staff through training, assignments and coaching.
• Developing and implementing process development procedures that are compliant to FDA, ISO, GMP and all other applicable agency regulations and standards.
• Identifying and assigning projects for continual improvement and expanded capabilities.
• Complying with the Health & Safety policies of the company and informing Management of unsafe working conditions.

• Bachelor's Degree in Engineering or related field of science.
• Minimum of 5 years of experience in Process Development & Engineering. Experience in the Medical Device, Pharmaceutical or Biotechnology industry is preferred.
• Minimum of 2 years of experience in personnel management and development.
• Thorough knowledge of medical device ISO quality systems and validation principles for manufacturing processes.
• Experience in design for manufacturing, process design, pFMEA, process validation and project management.
• Experience with statistical techniques (e.g., DOE, SPC, Six Sigma problem solving).
• Working knowledge of Lean & Six Sigma methodologies.
• Strong leadership, communication, and influencing skills in order to work effectively across organizational boundaries and influence decision-makers across multiple sites/regions/levels.