The Sr. Product Development Engineer is responsible for responding to Requests for Quotes, managing quick turn medical device OEM projects, prototyping catheters and balloon sub-assemblies, and managing projects from initial concept to production transfer.
Candidate must be able to work with minimal supervision in a fast-paced, customer-centric environment; should enjoy communicating with customers, vendors, and internal departments; and be passionate about our goal of consistent on-time delivery of high quality products.
This position is ideally suited for experienced Engineers that like to roll up their sleeves and spend time on the production floor. Typical projects last a few weeks, not months, so the position is a good fit for Engineers who enjoy autonomy and quick results from their efforts; less suitable for those who prefer managing long-term projects and delegating tasks to team members.
- Hands-on catheter/balloon design, development, and assembly
- Accurately predict project costs, material lead times, and product delivery schedules during the quoting process.
- Develop bills of materials and assembly method, and provide any needed training to technicians and assemblers.
- Develop balloons and catheter subassemblies according to customer design, performance, and quality specifications; on time and within budget.
- Meet deliverables on time while managing multiple customers and projects.
- Dig deep into developing balloons from the ground-up and develop an advanced understanding of the processes and parameters of balloon blowing
- Work closely with the engineering manager and technician to develop balloon forming parameters using both compliant and non-compliant balloon materials.
- Operate and set-up Interface BFM style machines to run both development and production balloon orders.
- Develop products and processes that are reliable as well as identify risks to the project, develop contingency plans, while outlining deliverables and milestones
- Directs and coordinates activities to develop products and ensure progress as the product specifications/limitations are developed into the technical specification
- Review and prepare status reports, modify schedules, and project plans as required
- Keeps stakeholders, customers, and others informed of project status and/or related issues
- Provide technical leadership, root cause analysis, and resolve customer or project related problems; materials, assembly, functional, or manufacturing related
- Apply design controls from initial customer requests throughout the products life cycle
- Writing, monitoring, managing, and reviewing protocols, including verification and validation tests, ECN, SOP's, BOM's, drawings, and may include calculation and/or FMEA etc...as required to develop, support, or maintain technical documentation
- Intimately involved in developing protocols, including verification and validation testing, drawings, calculation and/or FMEA etc...to develop and support technical documentation
- Be able to quickly iterate and "think-on-your-feet" to solve problems within a teamwork-driven atmosphere
- Collaborate to develop quality assurance, testing, regulatory compliance, and quality plans
- Address customer's issues: improve performance, appearance, and impact on end-user
EDUCATION / EXPERIENCE REQUIREMENTS:
- Bachelor's degree in Engineering with a focus in Plastics, Chemical, Biomedical or Mechanical Engineering preferred
- Master's degree in Plastics, Chemical, Biomedical or Mechanical Engineering preferred
- 5 years' experience in Medical Device manufacturing
SPECIALIZED SKILLS & OTHER REQUIREMENTS:
- Working knowledge of manufacturing processes related to medical device manufacturing
- Ability to prioritize and work independently as a self-starter with strong proactive work ethics
- Experience with design controls, FDA regulation, GMP practices, and QSR requirements
- Proficient in Microsoft Office and Microsoft Project
- Experience with Risk Analysis tools and procedures
- Proven track record in Leadership role and utilizing Project Management
- Proven track record in product development, design, and working closely with manufacturing
- Demonstrated customer relations, problem solving, and product development skills
- Ability to influence across boundaries, drive collaboration, and develop product to meet the end users expectations
- Must be well-organized, detail-oriented, with excellent oral and written communication skills
TRAVEL REQUIRED: 0-15 %
Teleflex is a global provider of specialty medical devices used for a range of procedures in critical care and surgery. We serve hospitals and clinicians in more than 130 countries with well known, trusted brands in vascular access, general and regional anesthesia, urology, respiratory care, cardiac care, and surgery.
We also provide products and services for device manufacturers. Our products are designed to cost effectively provide clinical benefits and enable healthcare providers to improve outcomes and enhance patient and provider safety.