Product Development Engineer I

Position Summary

The Product Development Engineer I (PDE I) is responsible for assisting and supporting the execution and oversight of Product Development projects within the OEM Performance Fibers (sutures) business unit. With a focus on new development projects such as sterile and non-sterile line extensions, new suture constructs, processes and technologies, they are responsible for supporting or leading Product Development projects of low complexity with minimal guidance, and more complex projects with a moderate to high level of guidance.  
The PDE I is expected to have a basic understanding of development, manufacturing, Design Control, medical device regulation, and project management. They will be expected to successfully support and carry out project deliverables/product development functions with a focus on quality, compliance, and customer needs. 
The scope of products for which the PDE I will be responsible for supporting includes sterile and non-sterile suture components, contract manufactured suture products, and sterile suture devices for the Mansfield, MA, Coventry, CT, and Nuevo Laredo, MX facilities. 
 

Principal Responsibilities

•    Support or lead Product Development projects and project activities of low complexity with minimal guidance, and more complex projects with a moderate to high level of guidance.  
•    Support moderate to highly complex Product Development projects with a high level of guidance.
•    Draft and route project initiation documents, identifying the required deliverables per local and global procedures, as well as governing regulations, with moderate guidance.
•    Interface with cross functional teams to track project deliverables, responsibility, and progress.
•    Coordinate and execute activities supporting Product Development initiatives and continuous improvement efforts such as procedure revisions, drawing reviews, creation of guidance documents, etc. 
•    Utilize available data to build timelines, task trackers, risk registers, meeting cadences, etc. based on basic knowledge of project management processes with moderate guidance. 
•    Assist with quoting exercises such as component sourcing, identification of project deliverables and risks, and timeline estimation, with guidance.
•    Review and prepare status reports, modify schedules, and project plans as required.
•    Manage stakeholder communication to ensure project status and/or related issues are effectively communicated. Collaborate with sales and customer care to support customer communications.
•    Support technical needs and inquiries for Sales, Quality, Regulatory, Marketing and other cross functional teams. 
•    Investigate and identify design control requirements with guidance. 
•    Understand basic product capabilities to support Performance Fibers projects and initiatives. 
•    Review and create product/customer specification documents based on internally validated specifications and inspection criteria.
•    Generate validation and verification protocols/reports, draft and review product labeling, initiate and manage sterility and biocompatibility assessments as well as other design control related documents with a high to moderate level of guidance. 
•    Ensure Teleflex Medical OEM suture products meet customer and quality system requirements. 
•    Support root cause analysis investigations and customer or project related problem resolution activities.
•    Coordinate and support proper creation and maintenance of drawings, procedures, design documents (DFMEA, FMEA, Traceability Matrix, etc) as well as other technical documentation.
•    Ensure projects are developed and documented compliant with the Quality System.
•    Collaborate to develop quality assurance, testing, regulatory compliance, and quality plans.
•    Support, lead and participate in design control reviews with guidance as needed.
•    Support EPIC Medtech customer visits and activities as needed.
•    Adhere to and ensure the compliance of Teleflex's Code of Conduct, all Company policies, rules, procedures and housekeeping standards.
•    Employ an entrepreneurial spirit and mindset to support growth of the team and business.
•    Other responsibilities as required. 
 

Education / Experience Requirements

•    Bachelor of Science in an Engineering or related technical discipline.
•    0-3 years of experience in medical device, regulated industry, or related field. 
 

Specialized Skills / Other Requirements

•    Has basic understanding of development and manufacturing processes.
•    Is able to utilize available data to build timelines, task trackers, risk registers, meeting cadences, etc. based on basic knowledge of project management processes with moderate guidance.
•    Demonstrates ownership of assigned tasks and takes responsibility for outcome. Works with direct manager to develop skillset with a view to individual execution. Develops proposed path based on sound logic and available information, with some guidance from direct manager.
•    Ability to maintain a positive attitude and takes ownership and constructively collaborates with colleagues at all levels of the organization.
•    Acknowledges conflict and works to constructively resolve, with support as needed. Understands the importance of multiple perspectives on a situation.
•    Practices active communication internally. Can effectively communicate with customers with support.
•    Has technical depth of understanding in SME areas in order to communicate technical feasibility of manufacturing.
•    Exhibits the determination and curiosity to solve problems. 
•    Employs a systematic structured approach to problem solving with little guidance.
•    Ability to handle multiple tasks and to prioritize/schedule work to meet project needs with routine supervision.
•    Experience with Microsoft Office – PC, Word, Excel, PowerPoint.
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