The Big Picture
The successful candidate will play a crucial role in developing, optimizing, and maintaining packaging processes for our medical devices, with a particular emphasis on class II medical devices. This role is integral to ensuring that our products are packaged in a way that meets regulatory standards and ensures product integrity and safety.
Your Impact Through Innovation
- Design, develop, and optimize packaging processes for medical devices, with a focus on catheter products.
- Identify opportunities for process improvements and implement changes to enhance efficiency, quality, and cost-effectiveness.
- Conduct process validation and testing to ensure packaging processes meet regulatory and quality standards.
- Prepare and maintain detailed documentation for packaging processes, including Standard Operating Procedures (SOPs), validation protocols, and reports.
- Work closely with R&D, Quality Assurance, and Regulatory Affairs teams to ensure packaging processes align with product requirements and regulatory guidelines.
- Investigate and resolve packaging process issues, implementing corrective and preventive actions as necessary.
- Qualify packaging equipment and develop test methods
- Ensure all packaging processes comply with relevant regulatory standards, including ISO 13485, FDA regulations, and GMP.
- Comply with the Health & Safety policies of the company and inform Management of unsafe working conditions
Your Unique Expertise
- Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, or a related field
- Minimum 3-5 years related working experience in process packaging within the medical device industry with a strong preference for catheter-related products.
- Experience in process validation, process FMEA, and project management.
- Experience with lean manufacturing principles.
- Strong analytical and problem-solving skills with the ability to troubleshoot and resolve complex packaging issues.
- Excellent written and verbal communication skills, with the ability to prepare clear and concise documentation.
- Ability to work effectively in a team environment and collaborate with cross-functional teams.
- Proficient in MS Office.
- Lean or Six Sigma training.
- Class II medical device products experience
Our Distinctive Edge
- Effortless commute: say goodbye to commuting challenges/hassles with our complimentary shuttles and subsidized transit options, making your journey to work a breeze.
- Work-life integration: Embrace a well-balanced work-life rhythm through our hybrid model and flexible hours, empowering you to thrive both personally and professionally.
- Making a difference: Be a force for good with one dedicated day off for impactful volunteering, supporting causes close to your heart.
- Nurturing your career: Propel your career forward with abundant opportunities for on-site training, workshops, and personal development.
- Rewards that count: Reap the benefits of our comprehensive rewards package, including tuition reimbursement and a health spending account.
- Unleash your spirit: Join a thriving workplace culture filled with employee-led clubs, campaigns, sports teams, and exhilarating activities – fostering camaraderie and fun.
Our Impact
Baylis Medical Technologies is a leader in the development and manufacturing of innovative medical devices in the fields of radiology and cardiovascular. Headquartered in Canada, the company also provides contract manufacturing services to some of the world’s leading medical device companies.
Baylis Medical Technologies is an equal opportunity employer and encourages applications from all qualified individuals.
Please inform us if you require any accommodation during the recruitment process.
Take the Leap
We are looking for talented individuals, like yourself, to join Baylis Medical Technologies and make a meaningful impact in the lives of patients. Be part of our mission to revolutionize patient care through cutting-edge technology and breakthrough solutions.
Are you ready to join us? Apply today and let’s shape the future of healthcare together!
Want an inside look at careers and life at Baylis? See all our current job opportunities here and follow us on LinkedIn!
While we thank all applicants, only those being considered for an interview will be contacted.
