Senior Process Engineer

The Big Picture

We are seeking a Senior Process Engineer to join our team and contribute to 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

At Baylis, we offer challenging and meaningful careers for individuals inspired to work in the biomedical industry. Our team consists of success-driven individuals with a strong inspiration to improve the lives of others.

Your Impact Through Innovation

The Senior process engineer will be responsible for:

• Developing manufacturing processes from concept to prototype.
• Leading process development projects.
• Manufacturing and testing prototypes.
• Working with external vendors to develop new process technologies and new materials
• Setting up new manufacturing equipment and production lines.
• Applying new technologies to optimize process design and performance.
• Setting up database of knowledge for new manufacturing technologies and new inspection technologies.
• Applying statistical and simulations to aid in device design.
• Researching new processes to meet product specifications and cost metrics.
• Evaluating processes and design alternatives.
• Applying lean manufacturing, problem-solving, and DOE principles.
• Develop and maintain PFMEAs to proactively identify and mitigate process risks.
• Completing process validation in the R&D or commercial production line (IQ, OQ, PQ, PV&V).
• Address work environmental issues, including H&S activities.
• Design and source equipment and tooling.
• 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.
• 5+ years of experience in manufacturing process design and optimization in the medical device industry.
• Deep understanding in one or more of the following catheter manufacturing technologies: jacket reflow, RF tipping, hydrophilic coating, coiling
• Practical experience with analytical instruments, such as 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
• Proficient in PFMEA development and facilitation, risk prioritization, and implementation of effective process control measures to ensure product quality and compliance.
• Knowledge of material joining, cutting, and forming methods for one of the following: stainless steel, PEBAX, Nylon, PTFE, FEP, PET, PEEK, TPU, hydrophilic and hydrophobic coatings
• Skilled in process capability analysis (Cp, Cpk, Ppk), SPC, and data-driven process optimization.
• Practical experience with test method validation and process validation (IQ, OQ, PQ, PPQ).
• Proven track record in leading process development from idea to working prototype.
• Practical experience working with external vendors to develop new materials and custom manufacturing equipment

Asset Skills:

• Master or PhD in field of Material science, advanced polymer science, metallurgical engineering, biomedical engineering, or mechanical engineering.
• 7+ years of experience in manufacturing process design and optimization in the medical device industry.
• 3+ years of experience in the catheter-based medical device industry.
• Deep understanding in one or more of the following: Braiding, laser cutting of stainless steel hypotube, nitinol hypotube with femto-second laser
• Practical experience with analytical instruments, such as SEM, EDX, DSC, FTIR, UVis, 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 setting

Our Distinctive Edge

• Effortless commute: say goodbye to commuting challenges/hassles with our complimentary shuttles and subsidized transit options, making your journey to work a breeze.
• Work-life integration: Embrace a well-balanced work-life rhythm through our hybrid model and flexible hours, empowering you to thrive both personally and professionally.
• Making a difference: Be a force for good with one dedicated day off for impactful volunteering, supporting causes close to your heart.
• Nurturing your career:  Propel your career forward with abundant opportunities for on-site training, workshops, and personal development.
• Rewards that count:  Reap the benefits of our comprehensive rewards package, including tuition reimbursement and a health spending account.
• Unleash your spirit:  Join a thriving workplace culture filled with employee-led clubs, campaigns, sports teams, and exhilarating activities - fostering camaraderie and fun.

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.

Are you ready to join us? Apply today and let's shape the future of healthcare together

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While we thank all applicants, only those being considered for an interview will be contacted.

This role has a base salary range of $94800 CAD to $154,050 CAD. Final offers are determined based on individual skills, experience, qualifications, location, and other job-related factors.