What are the responsibilities and job description for the Principal Medical Device Process Engineer position at Discover International?
Job Title: Manufacturing Process Development Lead for Medical Devices
About the Role
We are seeking an experienced professional to lead the development and enhancement of manufacturing processes for medical devices. As a Manufacturing Process Development Lead, you will collaborate with R&D to create specifications, oversee design and validation of equipment, and select raw materials.
Key Responsibilities
- Serve as technical lead for manufacturing process development and improvement.
- Design, lead, and execute equipment and process validations.
- Optimize manufacturing processes for new and existing medical devices.
- Apply DOE and SPC methodologies to refine processes.
- Implement vision systems to improve inspection methods.
- Collaborate on process improvements and validations.
- Drive root cause investigations for product and process failures.
- Manage prototype and pilot production builds.
- Set up and validate new manufacturing pilot lines.
- Develop manufacturing documents and enhance equipment design.
- Implement innovative technologies to improve processes.
- Monitor production to reduce waste and improve quality.
- Mentor and support team members.
- Ensure compliance with laws, regulations, and quality standards.
Qualifications
- Experience with catheters or stents/implants made from nitinol.
- Bachelor's degree in mechanical/manufacturing/industrial engineering or related field.
- 10 years of experience in manufacturing process development for medical devices.
- Strong communication and computer skills (MS Word, Excel, Outlook, Teams, CAD).
- Advanced degree in Engineering.
- Expertise in cGMP, DOE, SPC, and process validation.
- Experience with hydrophilic coating, polymer fusing, and nitinol stents.
- Lean/Six Sigma knowledge (Green or Black Belt preferred).
- Strong problem-solving skills.
- Proficiency with SolidWorks and fixture design.
