The Big PictureWe are seeking aProcess Engineer IIIto join our team and contribute to ourcatheter development team.The ideal candidate will build new prototypes and develop next-generation processes for medical devices.Key responsibilities includenew technologysearch, prototype building, mentoring junior engineers, andcomplying withregulatory standards.
This is a full-time position based atBaylis MedicalTechnologies Inc., Mississauga, Ontario, Canada
ImpactThrough InnovationTheProcess Engineer IIIwillbe responsible for:
- Developingmanufacturing processes from conceptto prototype.
- Leadingprocess developmentprojects.
- Manufacturingandtestingprototypes.
- Working with external vendorsto develop new processtechnologiesandnewmaterials
- Setting up new manufacturing equipmentand production lines.
- Applyingnewtechnologiestooptimizeprocess design and performance.
- Setting updatabaseof knowledge fornew manufacturingtechnologiesand new inspectiontechnologies.
- Applying statistical and simulationsto aid in device design.
- Researching newprocessesto meetproductspecifications and costmetrics.
- Evaluatingprocessesand design alternatives.
- Applyinglean manufacturing, problem-solving, and DOE principles.
- Completingprocess validationinthe R&D or commercial production line(IQ, OQ, PQ,PV&V).
- Address workenvironmental issues, including H&S activities.
- Design and source equipmentandtooling.
- Develop and maintain PFMEAsto proactivelyidentifyand mitigate process risks.
- Lead process validation and equipmentqualification.
- Supportand mentor junior engineers.
- Adhereto all corporate, quality, and health and safety policies.
Your Unique ExpertiseRequired skills:- Bachelor's degree in Engineeringor related field.
- 3-5years of experience in manufacturing process design and optimization inthe medical device industry.
- Deep understanding in one or more ofthe followingcatheter manufacturingtechnologies:jacketreflow,RFtipping, hydrophilic coating,coiling
- Practical experience withanalyticalinstruments, such asDSC,DMA,laser micrometer,basic dimensional measurementtools,tensile,torque, kink resistancetesting
- Experience with Six Sigmamethodologyand statistical analysis using Minitab, Python, or Monte Carlo Simulation software
- Practical experience with CAD design (SolidWorks) for fixture design
- Knowledge of material joining, cutting, and forming methods for one ofthe following: stainless steel, PEBAX, Nylon, PTFE, FEP, PET, PEEK,TPU, hydrophilic and hydrophobic coatings
- Practical experience withtestmethod validation and process validation (IQ, OQ, PQ, PPQ).
- Practical experience working with external vendorsto develop new materials andcustom manufacturing equipment
Assetskills:- Master or PhD infieldof Material science, advanced polymer science, metallurgical engineering,biomedical engineering,or mechanical engineering.
- 3+ years of experience inthe catheter-based medical device industry.
- Deep understanding in one or more ofthe following:Braiding,laser cuttingof stainless steelhypotube, nitinolhypotubewith femto-second laser
- Practical experience with analytical instruments, such as SEM, EDX, DSC, FTIR,UVis, surface energytester, laser micrometer, basic dimensional measurementtools
- Practical experience with3D printing, injection molding, or machining.
- Experience with vision systems for inspection in production setting
- Experience working with external vendorsto develop newmaterials and newprocesstechnologies.
- Proventrack recordin leading process developmentfrom ideato working prototype.
Our Distinctive Edge- Effortless commute: say goodbyeto commuting challenges/hassles with our complimentary shuttles and subsidizedtransitoptions, making yourjourneytowork a breeze.
- Work-life integration: Embrace a well-balanced work-life rhythm and flexible hours, empowering youtothrive both personally and professionally.
- Making a difference: Be a force for good with one dedicated day off for impactful volunteering, supporting causes closeto your heart.
- Nurturing your career: Propelyour career forward with abundantopportunities for on-sitetraining, workshops, and personal development.
- Rewardsthatcount: Reapthe benefits of our comprehensive rewards package, includingtuition reimbursementand a health spending account.
- Unleash your spirit: Joinathriving workplace culture filled with employee-led clubs, campaigns, sportsteams, and exhilarating activities - fostering camaraderie and fun.
This role has a base salary range of $73,000 CAD to $90,000 CAD. Final offers are determined based on individual skills, experience, qualifications, location, and other job-related factors.
