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SalaryJoin VitalPath in New Hope as an Research & Development Engineer!
About VitalPath
VitalPath is a trusted partner in the catheter design and manufacturing of custom medical devices that save lives and restore patient health and vital function. We’re excited about this important work and bring vital energy to our customer partnerships. In our growing organization it’s important that we continue to offer a small-company, family-oriented environment with competitive pay and benefits. If you want to make a difference in people’s lives and be a part of a friendly, fun place to work with people that value diversity, come join our team!
About the Position
The Research & Development (R&D) Engineer will be responsible for the development of catheter designs, processes, and test equipment. Working directly with the customer and cross-functional team to develop a catheter design that meets customer’s expectations of budget, schedule, design functionality while ensuring full compliance to FDA QSR (21 CFR 820), and applicable ISO 13485 requirements. Perform work in adherence to the VitalPath’s Quality Management System (QMS), including development and maintenance of documentation.
Responsibilities
- Work within development teams and/or manage smaller development projects along with interacting with customers and cross-functional teams
- Research, propose, and implement new technologies to further enhance the value added to customer projects
- Monitor project costs, material lead times, and product labor requirements to facilitate planning and scheduling
- Develop bills of materials, device history records, work instructions, inspection plans, test methods, and provide any needed training to technicians and assemblers
- Develop catheters and catheter subassemblies according to customer design, performance, and quality specifications, on time and within budget
- Work in a cross-functional environment partnering with Operations and Quality departments in order to transfer to production a product that meets customer requirements, on time delivery and quoted price
- Create specifications for tooling and fixturing for assembly, inspection and testing according to company quality standards
- Provide technical insight, participate in root cause analysis, and resolve customer or project problems related to materials, assembly, functional, or processes
- Assist in developing and executing Qualifications (IQ, OQ, PQ), Validations, Verifications, and Process FMEAs
- Support all company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirement
Requirements
- Bachelor’s Degree in Plastics, Chemical, Biomedical or Mechanical Engineering required
- Demonstrated excellent written and oral communication skills
- A working knowledge of minimally invasive Medical Device design, development, and manufacturing processes
- Must be able to work with a microscope and sit/stand for an extended period of time
- Must be able to life 25 lbs
Preferred
- 1 to 5 years in a catheter manufacturing environment, with exposure to product design and fixture design
- Excellent working knowledge of GD&T and Solidworks
- Experience with design controls, FDA regulation, GMP, GDP and QMS requirements
Benefits
- 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
- 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.
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