Process Development Technician

EOE Statement We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status or any other characteristic protected by law.

About the Organization We are a dedicated and multidisciplinary group of problem solvers with decades of engineering expertise. As a leader in complex catheter development we have assembled a team of world class engineers that don't shy away from challenges.

The Process Development Technician role is an integral part of the design and development process and works collaboratively with diverse project teams to deliver excellent products and documentation.

• Build and test catheters and sub-assemblies to meet the needs of patients and customers.
• Contribute to research and development projects and commercial manufacturing lines.
• Help drive the development of exciting new therapies by assisting with the design of new catheters.
• Execute process development activities on catheter assemblies in a cleanroom environment.
• Utilize common equipment in catheter manufacturing such as braiders, coilers, reflow ovens, tipping equipment, hot jaw bonding, laser bonding, adhesive bonding, etc.
• Document process settings and techniques in a cleanroom notebook for review by R&D engineers.
• Crosstrain other team members, shift to various value streams to undergo cross training.
• Perform in-process and final inspections using visual and mechanical methods to ensure product quality.
• Document production activities accurately in batch records and electronic systems.
• Perform duties in accordance with established procedures, including good documentation practices.
• Follow cleanroom protocols including gowning, material handling, and contamination control.
• Interact with internal teams to explore, troubleshoot and improve designs, fabrication processes and procedures.
• Perform weekly Product Processing Area cleaning as well as keeping daily lab tidiness and cleanliness.
• Perform other duties as needed.

• 1+ years of work experience in the medical device industry.
• Experience with ISO 13485, and FDA 21 CFR part 820.
• Proficient computer skills (MS Office, Excel).
• Good verbal and written communication skills. Must be detail oriented and able to work independently.

Salary range: $23.00 - $28.00

• 120 hours of paid time off per year
• 9 paid company holidays
• Health, Dental, & Vision coverage
• Short- & Long-Term Disability opt-in
• Health Savings Account (HSA) & employer contribution
• 401(k) & employer contribution