Senior Process Engineer

The Big Picture We are seeking a Senior 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 full‑time position is based at Baylis Medical Technologies Inc., Mississauga, Ontario, Canada.

Your Impact Through Innovation

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.

Set up a database of knowledge for new manufacturing and inspection technologies.

Apply statistical and simulation methods 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.

Develop and maintain PFMEAs to proactively identify and mitigate process risks.

Complete 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.

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 materials such as 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 materials 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 of Braiding, laser cutting of stainless steel hypotube, nitinol hypotube with femtosecond 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 settings.

Benefits

Flexible work‑life integration.

Dedicated day off for impactful volunteering.

Opportunities for on‑site training, workshops, and personal development.

Comprehensive rewards package, including tuition reimbursement and a health spending account.

Employee‑led clubs, sports teams, and activities promoting camaraderie and fun.

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.

This role has a base salary range of $89,000 CAD to $146,000 CAD. Final offers are determined based on individual skills, experience, qualifications, location, and other job‑related factors.

#J-18808-Ljbffr