Senior Process Engineer

Additional Locations:
Canada-ON-Mississauga;
Canada-ON-Toronto

Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance

About

The Role
We are seeking a Senior Process Engineer to join our NPI team and play a critical role in the development and launch of new products and technologies. In this position, you will support the entire lifecycle of product innovation—from early feasibility and process development through process verification, validation, and market release for clinical use. You will implement and coordinate new manufacturing processes and equipment, collaborate across R&D, Quality, and other departments, and ensure smooth transitions between project phases.

As projects move towards commercialization, you will also partner with Continuous Improvement teams to optimize manufacturing performance.

This role offers the opportunity to lead research, design, and integration of advanced manufacturing solutions within a dynamic, fast‑paced environment.

Your Responsibilities Will Include

Lead research, development, design, and evaluation of materials, components, assemblies, and processes that advance our technology and product portfolio.

Conduct feasibility studies and detailed engineering assessments to verify new designs, processes, and technologies.

Apply structured problem solving, lean principles, and best‑practice process development to drive product and process improvements.

Work closely with subject matter experts, R&D, and Quality teams to enhance manufacturing capabilities, develop concepts and influence design for manufacturability.

Plan, implement, and coordinate new product introductions, including product and process design, specifications, validations, equipment layout, production procedures, and procurement of materials.

Design and introduce new manufacturing processes, automation, and equipment to increase capabilities and efficiencies, delivering a competitive edge to our company and customers.

Develop and own critical processes for complex devices in pilot and production environments, ensuring robust and capable operations.

Design and execute structured experimental plans for data‑based decision‑making and continuous improvement.

Provide technical leadership and mentorship to technicians and entry‑level engineers.

Lead and organize technical reviews, communicate technical updates to stakeholders, and manage cross‑functional project deliverables related to Project Management, PDP/TDP, and Quality Systems.

Drive and support intellectual property generation and submissions related to product and process innovation.

Thrive in non‑routine situations with high levels of ambiguity, working independently to resolve technical challenges and deliver results.

Develop, write, and review process validation strategies and related deliverables (e.g., experiment tech reports, GR&R, TMV, IQ, FMEA) to meet quality system requirements.

Adhere to all Quality Management System requirements, demonstrate company values, and comply with Health & Safety policies, promptly reporting unsafe working conditions.

Occasional travel may be required, up to 15%.

Required Qualifications

Bachelor’s degree in Engineering or a related engineering field (Mechanical, Biomedical, Electrical, or Mechatronics preferred)

5+ years of relevant work experience

Experience in process design/development and product design for manufacturability, preferably in the medical device industry

Strong knowledge of manufacturing processes, materials, and technologies

Experience with process validation, process FMEA, project management, and lean manufacturing principles

Strong root cause analysis, analytical, organizational, communication (written and oral), and collaboration skills

Solid experimental design and statistical analysis knowledge

Proficient in MS Office

Preferred Qualifications

Experience in the medical device industry or other regulated sectors

Expertise in process development, process characterization, and overall validation processes

Lean or Six Sigma training desired

Strong analytical skills in business needs assessment and solution implementation

Compensation
Minimum Salary: $83,300

Maximum Salary: $132,300

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