The Big PictureThe successful candidate will lead the design, development, and implementation of manufacturing processes and technologies, supporting DMS and Radiology products. As a member of a cross-functional project core team, they will ensure that process development and validation activities are completed in accordance with the Baylis Quality Management System and enable successful transfer of products into production.
In this role, the candidate will execute advanced process engineering work within established procedures, contribute to project planning, and develop independent work plans to meet project objectives. They will also initiate and support continuous improvement efforts to enhance process efficiency, quality, and overall performance.
Your Impact Through Innovation- Lead the design, development, and implementation of manufacturing processes and technologies for DMS and Radiology products
- Execute advanced process engineering work using defined procedures, applying structured problem solving, root cause analysis, and statistical methods (SPC) to improve yield and process capability
- Plan, implement, and coordinate new product introductions, including product design, specifications, process validation (IQ/OQ/PQ), equipment and layout, and production readiness
- Collaborate with cross-functional SMEs to develop, validate, and transfer processes to production in accordance with the Baylis Quality Management System
- Develop and manage independent work plans, contributing to project planning and prioritizing activities to meet timelines and objectives
- Design and implement tooling, fixtures, and manufacturing processes to enhance capability, efficiency, and scalability
- Lead continuous improvement initiatives by identifying trends, driving corrective actions, and optimizing overall process performance
- Maintain accurate, traceable documentation and support change control activities (ECO/ECN) and audit readiness
- Provide technical guidance to technicians, engineering assistants, and junior engineers, supporting effective execution of project deliverables
- Adhere to all Quality Management System (QMS), regulatory (GMP, ISO), and company requirements
- Demonstrate Baylis values, work with integrity, and contribute as a collaborative team member
- Comply with Health & Safety policies and escalate unsafe conditions as required
Your Unique ExpertiseRequired Skills:- Bachelor's degree in Engineering
- 3-7 years of relevant engineering experience in the medical device industry
- Experience in process design/development, design for manufacturability, and product/process validation (IQ/OQ/PQ)
- Strong experience with structured problem solving, root cause analysis, and process optimization techniques (e.g., SPC)
- Knowledge of risk management principles (ISO 14971) and experience applying them in engineering decisions
- Experience supporting or contributing to project planning and managing independent work plans
- Familiarity with tooling/fixture design and manufacturing process development
- Strong analytical, organizational, and communication skills (written and verbal)
- Proficiency in MS Office
Asset Skills:- Lean or Six Sigma certification or training
- Experience with catheter manufacturing or similar high-precision medical device processes
Note: Professional Engineer (P.Eng.) license in Ontario is required, or candidates must be actively eligible and pursuing licensure. Candidates who do not hold a P.Eng. at the time of hire will perform engineering work under the supervision of a licensed Professional Engineer in accordance with the Professional Engineers Act (Ontario), and their title will be aligned accordingly until licensure is obtained.
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.
This role has a base salary range of $73,000 CAD to $90,000 CAD. Final offers are determined based on individual skills, experience, qualifications, location, and other job-related factors.
