The Big PictureThe Senior Process Engineer is a subject matter expert responsible for leading the design, development, validation, and implementation of advanced manufacturing processes and technologies supporting DMS and Radiology products. As a technical leader within cross-functional project teams, this individual drives manufacturing strategy, ensures robust process development, and enables successful commercialization of new products.
This role provides technical leadership for complex engineering initiatives, mentors junior engineers, and serves as a key decision-maker in process design, risk management, validation strategy, and continuous improvement activities. The Senior Process Engineer is expected to influence project direction, identify innovative manufacturing solutions, and drive operational excellence across the organization.
Your Impact Through Innovation- Lead the design, development, validation, and implementation of complex manufacturing processes, equipment, and technologies supporting new product introduction and sustaining engineering activities.
- Serve as the manufacturing process lead on cross-functional product development teams, providing strategic input on design for manufacturability, process capability, scalability, and cost optimization.
- Develop and execute manufacturing strategies to ensure successful transfer of products from development into commercial production.
- Lead process validation activities including validation strategy development, IQ/OQ/PQ execution, process characterization, and statistical analysis.
- Drive advanced root cause investigations using structured problem-solving methodologies, statistical tools, DOE, SPC, and risk-based decision making.
- Lead process risk management activities including PFMEA development, control plan creation, and identification of critical process parameters.
- Design and implement innovative tooling, fixtures, automation solutions, and manufacturing systems to improve safety, quality, efficiency, and throughput.
- Provide technical leadership during equipment selection, factory acceptance testing, site acceptance testing, and production qualification activities.
- Establish manufacturing standards, best practices, and engineering methodologies that improve organizational capability and consistency.
- Lead continuous improvement initiatives focused on yield improvement, scrap reduction, cycle time reduction, labor optimization, and cost savings.
- Identify and execute opportunities for automation, digital manufacturing, MES integration, and data-driven process improvements.
- Collaborate with Quality, R&D, Production, Regulatory Affairs, Supplier Quality, and Operations teams to address complex technical challenges.
- Author, review, and approve technical documents including protocols, reports, engineering assessments, process specifications, risk assessments, work instructions, and change controls.
- Provide mentorship, coaching, and technical guidance to Process Engineers, Engineering Technicians, and cross-functional team members.
- Support internal and external audits as a manufacturing process subject matter expert.
- Influence project priorities, resource planning, and technical decision-making to support departmental and organizational objectives.
- Adhere to all Quality Management System (QMS), GMP, ISO, regulatory, and company requirements.
- Demonstrate Baylis values, work with integrity, and contribute to a collaborative, high-performing engineering culture.
- Comply with Health & Safety policies and proactively identify and address unsafe conditions.
Your Unique ExpertiseRequired Skills:- Bachelor's Degree in Engineering.
- Minimum 5-7 years related working experience, preferably within the medical device or highly regulated manufacturing industry.
- Extensive experience in manufacturing process development, design for manufacturability (DFM), and process validation (IQ/OQ/PQ).
- Advanced knowledge of statistical methods including DOE, SPC, process capability analysis, and data-driven decision making.
- Strong expertise in risk management methodologies, including ISO 14971 and PFMEA.
- Experience leading complex New Product Introduction (NPI) and technology transfer projects.
- Demonstrated ability to independently lead technical projects with minimal supervision.
- Strong understanding of automation, manufacturing equipment, tooling, fixtures, and production system design.
- Experience developing manufacturing strategies and influencing cross-functional stakeholders.
- Excellent problem-solving, communication, presentation, and stakeholder management skills.
- Proven ability to mentor and develop junior engineering talent.
- Proficiency in MS Office, Minitab, and manufacturing data analysis tools.
Asset Skills:- Lean Six Sigma Green Belt or Black Belt certification.
- Experience with assembly automation, injection molding, bonding, laser processing, or other high-precision medical device manufacturing technologies.
- Experience with Manufacturing Execution Systems (MES), and other digital manufacturing.
- Experience leading global supplier process development or external manufacturing transfers.
- Project Management certification (PMP) or equivalent experience.
- Experience supporting MDSAP, FDA, and ISO 13485 audits.
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 $89,000 CAD to $135,000 CAD. Final offers are determined based on individual skills, experience, qualifications, location, and other job-related factors.
