Your Impact Through Innovation- Lead the design, development, and implementation of medical device packaging solutions so that product integrity, contamination control, and patient safety aremaintainedin compliance with ISO 13485 and FDA QSR requirements.
- Define andoptimizepackaging systems and material flows for raw materials, WIP, and finished goods so that product identification, handling, protection, and traceability are preserved across manufacturing and distribution.
- Assess and introduce packaging materials, technologies, and concepts using risk-based approaches so that performance, compliance, and total cost of ownership areoptimizedwithout increasing quality or regulatory risk.
- Design and implement packaging tooling, fixtures, and equipment so that packaging processes arevalidated, repeatable, and capable of consistently meeting defined quality requirements.
- Collaborate with R&D, Quality, Manufacturing, Regulatory, Supply Chain, and suppliers so that packaging solutions are fully aligned with product design inputs, process constraints, and regulatory strategies.
- Plan, execute, and document packaging verification and validation activities so that objective evidence of packaging conformity isestablishedand maintained within the DHF and technical documentation.
- Monitor applicable standards, guidance, and emerging technologies so that best practices are proactively applied to improve compliance, robustness, and operational efficiency.
- Independently plan and manage technical activities and timelines so that packaging deliverablessupport on-timeproduct development, transfers, and sustaining initiatives.
- Lead investigations, root cause analysis, and CAPA for packaging-related issues so that risks to product quality, patient safety, and supply continuity are eliminated and prevented from recurring.
- Conceptualize, design, develop and implement packaging solutions for medical devices packaging, ensuring compliance with regulatory standards.
Your Unique ExpertiseRequired Skills:- Bachelor's degree in Packaging Engineering, Mechanical Engineering, ora relatedengineering discipline.
- Demonstrated experience designing, developing, and implementing medical device packaging solutions within a regulated environment, with a strong preference for ISO 13485 and FDA-regulated industries.
- Proven end-to-end experience implementing complete packaging systems, including raw material packaging, WIP containment, primary and secondary product packaging, palletization, shipping to sterilization, sterilization compatibility, warehouse distribution, and international transportation involving multiple handling points.
- Proficiencyin CAD tools for package design, tooling, fixture development, and communication of technical requirements to internal teams and external suppliers.
- Strong working knowledge of medical device packaging regulations and standards, including ISO 11607, FDA QSR, and applicable transportation and distribution requirements.
- Demonstrated experience with risk-based, hypothesis-driven experimental design, including development of test protocols, statistical analysis of results, and interpretation of data to support design and process decisions.
- Ability to structure, analyze, and manage technical data effectively, including organizing validation and test data in a manner that supports decision-making, traceability, and regulatory documentation.
Asset Skills:- Related experience in medical devices with a focus onproduct packaging,componentpackaging, transportation, andlogistics
- Experience supporting medium- to high-volume manufacturing environments (approximately 10,000to 10,000,000 units per year), with packaging solutions designed for scalability, robustness, and operational efficiency.
- Lean Six Sigma Blackbelt certified
- Knowledge of design requirements as per 21 CFR 820 and ISO 13485.
- Experience with drafting andmaintainingDHF and DMR documentation.
- Proficiencyin communicating design and project requirements at varying levels, internally and with vendors
- Understanding ofEO sterilization processes and sterilization validation per ISO 11135.
Our Distinctive Edge- Effortless commute: say goodbye to commuting challenges/hassles with our complimentary shuttles and subsidized transit options, making yourjourney towork 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: Propelyour career forward with abundant opportunities for on-site training, workshops, and personal development.
- Rewards that count: Reapthe benefits of our comprehensive rewards package, including tuition reimbursement and a health spending account.
- Unleash your spirit: Joina thriving workplace culture filled with employee-led clubs, campaigns, sports teams, and exhilarating activities - fostering camaraderie and fun.
Our ImpactBaylis 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.
Take the LeapWe are looking for talented individuals, like yourself, to join Baylis Medical Technologies and make a meaningful impactinthe lives of patients. Be part of our mission to revolutionize patient care throughcutting-edgetechnology and breakthrough solutions.
Are you ready to join us? Apply today andlet'sshape the future of healthcare together!
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While we thank all applicants, only those being considered for an interview will be contacted.
This role has a base salary range of $89,000 CAD to $135,000 CAD. Final offers are determined based on individual skills, experience, qualifications, location, and other job-related factors.
