What are the responsibilities and job description for the Pre-Production Operator III (R&D) position at VitalPath?
Join VitalPath in New Hope as a Pre-Production Operator III!
About VitalPath
VitalPath is a trusted contract manufacturing partner that delivers high-quality complex catheter solutions around the world that save lives and restore patient health and vital function. We strive to treat every product we design and manufacture to the highest level of quality and awareness that these products are going to be used inside of a patient, possibly even our own family members.
Our employees impassioned hard work and dedication are at the core of our success. Every function within our organization plays a crucial role in our mission and is deeply valued for its contribution to achieving our shared goals of quality, innovation, continuous improvement, and operational excellence.
As a fast-growing organization, we bring harmony and standardization across VitalPath with a strong vision in mind - We are one VitalPath. We embrace our diversity, celebrate each others success, support one another through change, and continue to grow as a high-performing organization. We aim to shape our corporate culture to enhance team member engagement, skills, and productivity so that VitalPath is an employer of choice. If you’re ready to contribute to groundbreaking medical advancements in a collaborative, fast paced environment, we invite you to apply and be part of our growth!
About the Position
The Pre-Production Operator III is responsible for performing highly complex catheter assembly tasks to support project from initial prototypes to pilot manufacturing. This position is expected to be self-sufficient and work on challenging projects with verbal guidance only. This position must be able to effectively communicate with all members of the Research & Development team. This position is expected to provide support and training for Pre-Production Operators I & II and should be skilled at directing a team on the completion of projects.
Shift/Schedule
- Monday - Friday 6am-2:30pm
- Understand, follow and enforce Standard Operating Procedures, Work Instructions, manufacturing processes per as defined on travelers, Good Documentation Practices (GDP), current Good Manufacturing Practices and safety procedures
- Understand proper lot traceability for materials and products
- Responsible for completion and review of manufacturing documentation completely, correctly and in a timely manner for self and others
- Able to explain problems, provide feedback to others, and receive feedback effectively
- Maintain VitalPath’s quality and workmanship standards in all aspects of the job and complete inspection of product against these standards; Lead as a role model for these standards
- Execute assembly of highly complex catheters with limited documentation and/or redlined prints in order to meet required deadlines
- Manage working on multiple builds within a single shift
- Perform builds using specific process parameters to support process development and validation activities
- Complete material returns, including executing material counts and updating label, upon completion of builds; review other team members returns for accuracy and timeliness
- Document personal performance and monitor personal and team performance
- Identify opportunities for process improvement and communicate to decision makers successfully
- Assist R&D team with prototypes transfers to pre-production
- Train Pre-Production Operator I & II on processes or operations
- Maintain a clean general work area during shift, including performing line clearance as needed
- Use proper inspection tools to complete visual and dimensional inspection of product; Identify and communicate instances of non-conforming product and help to reduce non-conformances
- Identify challenges, problem solve, and troubleshoot issues in collaboration with R&D engineers and technicians
- Take initiative to find work when necessary; provide direction for Pre-Production Operators I & II in need of work
- High School diploma, GED or equivelant
- Ability to follow and provide written and verbal instructions
- 5 years’ experience working in Research & Development or experience leading in production assembly
- Attention to detail
- Ability to read and understand measurements
- Ability to read and understand minensions and tolerances on blueprints/specifications
- Proficient basic math skills including metric conversions
- Ability to lead in a team environment and promote collaboration across functions
- Must be able to life 25 lbs
- Must be able to sit/stand for an extended period of time in a cleanroom environment
- Must be able to work under a microscope for extended periods of time
- Proficient in reading, writing and speaking English
- Expert understanding of processes and workmanship standards used in catheter assembly
- Proficient in Microsoft applications such as Word, Excel, and Outlook
- Comprehensive, Low Cost Health and Dental Insurance Plans Available
- Vision Insurance
- Health Savings Account with company contribution
- Short and Long Term Disability
- Supplemental insurances (short term disability, AD&D, life insurance, and more)
- Paid Time Off
- Sick Time Off
- Paid Holidays
- 401K with company match
- Competitive compensation
- Opportunities for career growth and advancement
VitalPath is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, work related mental or physical disability, veteran status, sexual orientation, gender identity, or genetic information. VitalPath participates in E-Verify.
