Staff Process Engineer - Mississauga - Baylis Medical Technologies

Description

Overview

The Big Picture

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. This is a full-time position based at Baylis Medical Technologies Inc., Mississauga, Ontario, Canada.

Baylis Medical Technologies is a leader in the development and manufacturing of innovative medical devices in radiology and cardiovascular. The company is headquartered in Canada and provides contract manufacturing services to leading medical device companies. We are an equal opportunity employer and encourage applications from all qualified individuals. Please inform us if you require any accommodations during the recruitment process.

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 new materials.
• Set up new manufacturing equipment and production lines.
• Apply new technologies to optimize process design and performance.
• Set up a knowledge database for new manufacturing technologies and inspection technologies.
• Apply statistical methods 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 the R&D or commercial production line (IQ, OQ, PQ, PV&V).
• Address work environment issues, including health and 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.

Your Unique Expertise

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 in one or more catheter manufacturing technologies (e.g., jacket reflow, RF tipping, hydrophilic coating, coiling).
• Practical experience with analytical instruments (DSC, DMA, laser micrometer, basic dimensional measurement tools, tensile, torque, kink resistance testing).
• Experience with Six Sigma methodology and 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 stainless steel, PEBAX, Nylon, PTFE, FEP, PET, PEEK, TPU, and related coatings.
• Practical experience with test method validation and process validation (IQ, OQ, PQ, PPQ).
• Practical experience working with external vendors to develop new materials and custom manufacturing equipment.

Asset Skills

• Master or PhD in materials 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 hypotubes, nitinol hypotubes with femto-second laser.
• Practical experience with analytical instruments (SEM, EDX, DSC, FTIR, UV-Vis, surface energy tester, laser micrometer, basic dimensional measurement tools).
• Practical 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 new process technologies.
• Proven track record in leading process development from idea to working prototype.

Our Distinctive Edge

• Effortless commute with complimentary shuttles and subsidized transit options.
• Work-life integration through hybrid model and flexible hours.
• One dedicated day off for volunteering to support causes close to your heart.
• On-site training, workshops, and personal development opportunities.
• Comprehensive rewards package, including tuition reimbursement and a health spending account.
• Thriving workplace culture with employee-led clubs, campaigns, sports teams, and activities.

Our Impact

Baylis Medical Technologies is a leader in development and manufacturing of innovative medical devices in radiology and cardiovascular. Headquartered in Canada, the company also provides contract manufacturing services to leading medical device companies.

Take the Leap: We are looking for talented individuals to join Baylis Medical Technologies and make a meaningful impact in patients' lives. 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 here and follow us on LinkedIn. This role has a base salary range of CAD 76,400 to CAD 124,150. Final offers are determined based on individual skills and other factors.