Senior Process Engineer (Advanced Development)
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We are seeking a Senior Process Engineer to join our team and contribute to our advanced material and manufacturing technology development efforts. 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.
At Baylis, we offer challenging and meaningful careers for individuals inspired to work in the biomedical industry. Our team consists of intelligent and success-driven individuals with a strong inspiration to improve the lives of others.
Impact Through Innovation
The Senior Process Engineer - Advanced Development will be responsible for:
- Developing manufacturing processes from concept to prototype.
- 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 a knowledge database for new manufacturing and inspection technologies.
- Applying statistical methods and simulations to aid 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.
- Completing process validation in R&D or commercial production (IQ, OQ, PQ, PVV).
- Addressing work environmental issues, including H&S activities.
- Designing and sourcing equipment and tooling.
- Leading process validation and equipment qualification.
- Supporting and mentoring junior engineers.
- Adhering to all corporate, quality, and health and safety policies.
The Big Picture
We are seeking a Senior Process Engineer to join our team and contribute to our advanced material and manufacturing technology development efforts. 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.
At Baylis, we offer challenging and meaningful careers for individuals inspired to work in the biomedical industry. Our team consists of intelligent and success-driven individuals with a strong inspiration to improve the lives of others.
Impact Through Innovation
The Senior Process Engineer - Advanced Development 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 a knowledge database for new manufacturing and inspection technologies.
- Applying statistical methods and simulations to aid 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.
- Completing process validation in R&D or commercial production (IQ, OQ, PQ, PVV).
- Addressing work environmental issues, including H&S activities.
- Designing and sourcing equipment and tooling.
- Leading process validation and equipment qualification.
- Supporting and mentoring junior engineers.
- Adhering to all corporate, quality, and health and safety policies.
Your Unique Expertise
Required skills:
- Bachelor's degree in Engineering or related field.
- 6+ years of experience in manufacturing process design and optimization in the medical device industry.
- Deep understanding of one or more of the following: braiding, coiling, jacket reflow, laser cutting, injection molding, RF tipping, and adhesive bonding.
- Practical experience with analytical instruments, such as SEM, EDX, DSC, FTIR, UV-Vis, surface energy testers, laser micrometers, and basic dimensional measurement tools.
- Knowledge of material joining, cutting, and forming methods for materials like stainless steel, PEBAX, Nylon, PTFE, FEP, PET, PEEK, TPU, and coatings.
Asset skills:
- Master's or PhD in Material Science, Polymer Science, Metallurgical Engineering, or Mechanical Engineering.
- 3+ years of experience in the catheter-based medical device industry.
- Experience with Six Sigma and statistical analysis tools like Minitab, Python, or Monte Carlo simulations.
- Practical experience with CAD design (SolidWorks) for fixtures, 3D printing, injection molding, or machining.
- Experience with vision inspection systems.
- Experience with test method validation and process validation (IQ, OQ, PQ, PPQ).
- Proven track record in leading process development from concept to prototype.
- Experience collaborating with external vendors for new materials and processes.
Our Distinctive Edge
- Effortless commute with shuttles and subsidized transit.
- Flexible work hours and hybrid work model for work-life balance.
- One day off dedicated to volunteering.
- Opportunities for training, workshops, and personal development.
- Comprehensive rewards including tuition reimbursement and health benefits.
- Employee-led clubs, campaigns, sports teams, and activities for camaraderie.
Baylis Medical Technologies is a leader in innovative medical devices, headquartered in Canada, also providing contract manufacturing services globally. We are an equal opportunity employer and encourage applications from all qualified individuals. Please inform us if you require accommodations during the recruitment process.