Senior Process Engineer

The Mullings Group; Greater Toronto Area; On-site; CAD 80,000 - 110,000; Full time

Job summary

A leading company in the biomedical industry is seeking a Senior Process Engineer to drive advanced material and manufacturing technology development. The role involves developing prototypes, optimizing processes, and mentoring junior engineers, contributing to impactful innovations in medical devices.

Qualifications

• 6+ years of experience in medical device manufacturing.
• Experience with Six Sigma methodology and statistical analysis.
• Practical experience with test method validation.

Responsibilities

• Develop manufacturing processes from concept to prototype.
• Work with external vendors to develop new process technologies.
• Lead process validation and equipment qualification.

Skills

Manufacturing Process Design

Lean Manufacturing

Problem Solving

Statistical Analysis

Mentoring

Education

Bachelor's degree in Engineering

Master or PhD in Material Science

Tools

SolidWorks

Minitab

Python

Job description

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Global Medtech Executive Recruitment : Start-up -> Fortune 500 : IC -> C-Level : Emerging Medtech Trends & Insights

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.

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 database of knowledge for new manufacturing technologies and new inspection technologies.
• Applying statistical and simulations to aid in 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 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.
• 6+ years of experience in manufacturing process design and optimization in the medical device industry.
• Deep understanding in 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, UVis, surface energy tester, laser micrometer, basic dimensional measurement tools
• Knowledge of material joining, cutting, and forming methods for one of the following: stainless steel, PEBAX, Nylon, PTFE, FEP, PET, PEEK, TPU, hydrophilic and hydrophobic coatings
• Master or PhD in field of Material science, advanced polymer science, metallurgical engineering, or mechanical engineering.
• 3+ years of experience in the catheter-based medical device industry.
• 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, 3D printing, injection molding, or machining.
• Experience with vision systems for inspection in production setting
• 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.
• Experience working with external vendors to develop new materials and new process technologies.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Manufacturing, Engineering, and Project Management

• Industries

  Medical Equipment Manufacturing, Manufacturing, and Engineering Services

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