Electrical Engineer
Red 6
Assembly
Associate Manufacturing Engineer
Vital Bio
full-time
Posted on:
Origin: • 🇨🇦 Canada
Visit company websiteJob Level
JuniorMid-Level
Tech Stack
Assembly
About the role
- Support the transfer of new products and processes from engineering and assay development into cGMP manufacturing
- Assist in designing, developing, and refining assembly processes and workflows for reagent-containing consumables and instruments, including those with molded plastic components
- Design, implement and qualify assembly fixtures and tooling to facilitate the manufacturing process
- Help document and implement process changes, standard operating procedures (SOPs), work instructions, and acceptance criteria to ensure consistent, compliant operations
- Participate in process validation and equipment qualification activities (IQ, OQ, PQ) under supervision
- Contribute to the investigation and troubleshooting of manufacturing issues, assisting with root cause analysis and implementation of corrective actions
- Gather, analyze, and report manufacturing data to support process optimization, yield improvements, and cost reduction initiatives
- Help maintain and update cGMP manufacturing records and documentation in compliance with ISO 13485 and FDA requirements
- Work collaboratively with engineering, assay development, and quality teams to address daily production needs and support ongoing improvement projects
Requirements
- Bachelor’s degree in Mechanical Engineering, Bioengineering, Chemical Engineering, or a related STEM field (or equivalent combination of education and hands-on experience)
- 1–3 years of experience in a manufacturing, production, or process engineering environment; internships and co-op placements welcome
- Understanding of basic manufacturing principles, process control, and design for manufacturability
- Exposure to cGMP, ISO 13485, or similar regulated environments is a plus
- Familiarity with mechanical assembly, validation/qualification (IQ/OQ/PQ), and documentation practices
- Strong problem-solving, analytical, and organizational skills with keen attention to detail
- Good communication skills, a collaborative mindset, and enthusiasm for learning and development
- Bonus: Experience in diagnostics, medical devices, or life sciences manufacturing
- Bonus: Hands-on experience with assembly automation or high-volume production
- Bonus: Exposure to Lean Manufacturing, Six Sigma, or other process improvement methodologies
- Bonus: Project or team leadership experience in academic or workplace settings
- Bonus: An appreciation for puns and a team-oriented approach
