Process Development Engineer I

Role Overview

As a Process Development Engineer I, you will play a key role in bringing life-saving medical devices from early-stage prototypes to scaled manufacturing. Working under the guidance of senior engineering staff, you will bridge the gap between design concepts and reliable production processes. This position is ideal for an early-career engineer who thrives on hands-on technical problem-solving, data-driven optimization, and collaborating closely with production teams in a regulated manufacturing environment.

What Success Looks Like

In your day-to-day role, you will divide your time between the engineering lab and the manufacturing floor. You will set up and operate R&D equipment, run engineering studies, and work directly with operators and technicians to understand how our processes function in practice. You will collect and analyze data to find the root causes of process variations and implement practical solutions.

Over time, success means taking ownership of key engineering builds—including biocompatibility, design verification, and validation runs (OQ/PQ). You will become highly proficient at planning and conducting Design of Experiments (DOE), writing clear technical reports with minimal supervision, and safely guiding manufacturing improvements that meet our strict quality and regulatory standards.

Key Responsibilities

• Support process development activities from proof-of-concept prototypes through manufacturing validation and production.
• Plan, coordinate, and execute engineering activities and studies supporting both existing products and new product development initiatives.
• Evaluate products, equipment, tooling, and process capabilities, providing recommendations for modifications and improvements.
• Investigate process-related issues through root-cause analysis, data evaluation, and corrective actions.
• Coordinate and execute manufacturing and training activities associated with engineering builds, including biocompatibility, design verification, OQ, and PQ builds.
• Conduct engineering experiments, process characterization, and Design of Experiments (DOE) activities.
• Record test procedures, collect and analyze data, and prepare accurate technical reports and documentation.
• Maintain compliance with all company safety, quality, and regulatory policies.

What You Bring

• Education: Bachelor’s degree in Engineering (Mechanical, Biomedical, Materials, Chemical, or a related technical discipline).
• Experience: 8 months to 1.5 years of experience in a similar engineering role (relevant co-op or internship experience in manufacturing will be considered).
• Communication: Advanced English proficiency, with the ability to write clear technical reports and collaborate effectively across teams.
• Technical Skills: Strong foundation in data analysis, statistics, and the ability to interpret technical and mechanical drawings.
• Practical Aptitude: A strong hands-on approach and comfort working in a manufacturing and laboratory environment.
• Tools: Proficiency with Microsoft Office, particularly Excel for data organization.

Nice-to-Haves

• Prior experience working within the medical device industry.
• Familiarity with process validation protocols, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
• Experience with statistical analysis software, particularly Minitab.
• Experience using SolidWorks for tooling or fixture design.
• Familiarity with project management tools such as Workfront.

Ready to Apply?

If you are an analytical, hands-on engineer looking to build your career in medical device manufacturing, we encourage you to apply. We look forward to reviewing your application and discussing how your skills align with our engineering goals.