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.
• Leading process development projects.
• 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

Asset skills:

• 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.