Senior Process Engineer - Packaging

Baylis Medical Technologies•Mississauga, ON

1d•Hybrid

About The Position

Baylis MedTech is a dynamic and innovative medical technology company dedicated to developing cutting-edge products that improve patient outcomes. As our team continues to grow, we are seeking a passionate Senior Process Engineer - Packaging to join our Process Engineering division. This role offers an exciting opportunity to support our diverse portfolio of medical devices through the design and development of component packaging, work-in-progress (WIP) material packaging, final product packaging, as well as medical device packaging production lines and logistics lane design. At Baylis, we offer challenging and meaningful careers for individuals inspired to work in the biomedical industry. Our team consists of intelligent and success-driven individuals with a strong inspiration to improve the lives of others.

Requirements

Bachelor’s degree in Packaging Engineering, Mechanical Engineering, or a related engineering 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.
Proficiency in 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.

Nice To Haves

Related experience in medical devices with a focus on product packaging, component packaging, transportation, and logistics
Experience supporting medium- to high-volume manufacturing environments (approximately 10,000 to 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 and maintaining DHF and DMR documentation.
Proficiency in communicating design and project requirements at varying levels, internally and with vendors
Understanding of EO sterilization processes and sterilization validation per ISO 11135.

Responsibilities

Lead the design, development, and implementation of medical device packaging solutions so that product integrity, contamination control, and patient safety are maintained in compliance with ISO 13485 and FDA QSR requirements.
Define and optimize packaging 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 are optimized without increasing quality or regulatory risk.
Design and implement packaging tooling, fixtures, and equipment so that packaging processes are validated, 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 is established and 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 deliverables support on-time product 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.