Staff Process Engineer

Join to apply for the Staff Process Engineer role at Baylis Medical Technologies We are seeking a Staff Process Engineer to join our catheter development team. The ideal candidate will build new prototypes and develop next‑generation processes for medical devices. Key responsibilities include new technology search, prototype building, mentoring junior engineers, and complying with regulatory standards. Position: full‑time, based at Baylis Medical Technologies Inc., Mississauga, Ontario, Canada. Responsibilities Develop manufacturing processes from concept to prototype. Lead process development projects. Manufacture and test prototypes. Work with external vendors to develop new process technologies and materials. Set up new manufacturing equipment and production lines. Apply new technologies to optimize process design and performance. Establish a knowledge database for new manufacturing and inspection technologies. Apply statistical analysis and simulations to aid in device design. Research new processes to meet product specifications and cost metrics. Evaluate processes and design alternatives. Apply lean manufacturing, problem‑solving, and DOE principles. Complete process validation in R&D or commercial production lines (IQ, OQ, PQ, PV & V). Address work‑environment issues, including health & safety activities. Design and source equipment and tooling. Develop and maintain PFMEAs to proactively identify and mitigate process risks. Lead process validation and equipment qualification. Support and mentor junior engineers. Adhere to all corporate, quality, and health and safety policies. Required Skills Bachelor's degree in Engineering or related field. 3–5 years of experience in manufacturing process design and optimization in the medical device industry. Deep understanding of catheter manufacturing technologies such as jacket reflow, RF tipping, hydrophilic coating, and coiling. Practical experience with analytical instruments (DSC, DMA, laser micrometer, dimensional measurement tools, tensile, torque, kink resistance testing). Experience with Six Sigma methodology and statistical analysis using Minitab, Python, or simulation software. Proficiency with CAD design (SolidWorks) for fixture design. Knowledge of material joining, cutting, and forming methods (stainless steel, PEBAX, Nylon, PTFE, FEP, PET, PEEK, TPU, hydrophilic and hydrophobic coatings). Experience with test method validation and process validation (IQ, OQ, PQ, PPQ). Experience working with external vendors to develop new materials and custom manufacturing equipment. Asset Skills Master’s or PhD in a relevant field (Material science, advanced polymer science, metallurgical engineering, biomedical engineering, or mechanical engineering). 3+ years of experience in the catheter‑based medical device industry. Deep understanding of braiding, laser cutting of stainless steel hypothe tubes, nitinol hypothe tubes with femtosecond laser. Proficiency with advanced analytical instruments (SEM, EDX, DSC, FTIR, UV‑vis, surface energy tester, laser micrometer). Experience with 3D printing, injection molding, or machining. Experience with vision systems for inspection in production settings. Experience working with external vendors to develop new materials and process technologies. Proven track record in leading process development from idea to working prototype. Benefits & Perks Effortless commute: complimentary shuttles and subsidized transit options. Work‑life integration: hybrid model and flexible hours. One dedicated day off for volunteering. On‑site training, workshops, and personal development opportunities. Comprehensive rewards package, including tuition reimbursement and a health spending account. Employee‑led clubs, campaigns, sports teams, and exhilarating activities. 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 accommodations 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. 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 and follow us on LinkedIn. #J-18808-Ljbffr