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 Packaging Design Lead 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 Packaging Design Lead will lead strategic initiatives that enable improvement in structure, systems, processes, and capabilities across the organization. The candidate will proactively identify opportunities in packaging and/or business processes to improve quality, cost, delivery, compliance, and innovation/improvement as well as to ensure alignment to industry requirements.
Specific responsibilities of the position will include:
- Designing, developing and launching sterile medical device packaging and labeling.
- Leading key strategic projects in Packaging, focused on cost, quality, compliance, delivery and innovation.
- Ensuring the application of standardized project management and risk management methodologies across all packaging programs to ensure consistent execution and delivery.
- Driving resolutions to project challenges by gaining cooperation of business partners on program execution plans.
- Championing site-level key performance indicators (KPIs), including Packaging Excellence.
- Working with cross-functional team members to ensure clear internal and external communication of project/program objectives, deliverables and timing of key milestones.
- Driving strong connections to R&D and Packaging Innovation in leveraging key competencies during early phase PDP and VOC best practices for the team.
- Responsibility for the development and maintenance of project plans and budget.
- Performing duties in compliance with applicable FDA and state regulations as well as international standards including, but not limited to, ISO 13485.
In order to perform the responsibilities of this challenging role, the following qualifications are mandatory:
- Bachelor's Degree in Engineering or related field of science.
- Minimum 10 years of related professional experience
- Working knowledge of packaging materials, sterilization methods, test methods, process validation, and international standards related to sterile medical device packaging.
- Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures and/or governmental regulations.
- Ability to write reports, business correspondence and procedure manuals.
- Ability to effectively present information and respond to questions from managers, customer and business partners.
- Ability to drive a problem-solving process, interpret problems, collect data, establish facts and draw valid conclusions.
- Ability to interpret an extensive variety of technical instructions in mathematical and/or diagram form and to deal with several abstracts and/or concrete variables.
- Must have successfully completed projects (e.g., line extensions, packaging system modifications, etc.) of sufficient complexity.
- Must have a basic understanding of theoretical technical principles in the following areas: mechanical drafting, geometrical dimensioning and tolerancing, computer aided design, statistics, basic packaging methods, packaging evaluation, packaging materials and technical writing.