Product Development Engineer II

Position Summary

The Product Development Engineer II (PDE II) is responsible for leading 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 leading and supporting Product Development projects of low to moderate complexity with minimal to moderate guidance. They are also responsible for leading and supporting projects of high complexity with moderate guidance. 
The PDE II is expected to have a moderate level of proficiency in development, manufacturing, Design Control, medical device regulation, and project management. They will be expected to successfully carry out and support project deliverables/product development functions with a focus on quality, compliance, and customer needs. 
The scope of products for which the PDE II 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

•    Lead Product Development projects and project activities of low to moderate complexity with minimal to moderate guidance.  
•    Support moderate to highly complex Product Development projects with a moderate to high level of guidance.
•    Develop custom devices, sutures and subassemblies according to customer design, performance, and quality specifications; on time and within project constraints.
•    Draft and route project initiation/closure documents, identifying the required deliverables per local and global procedures, as well as governing regulations, with minimal to moderate guidance based on project complexity.
•    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. 
•    Apply structured project management principles such as scope definition, timeline development, contingency planning, and risk planning with a low level of guidance.  
•    Lead quoting exercises such as component sourcing, identification of project deliverables and risks, and timeline estimation, of low to moderate complexity with minimal guidance.
•    Review and prepare status reports, modify schedules, and project plans of moderate complexity 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. Serve as technical resource for team or customers for moderately complex aspects of business/product portfolio.
•    Understand design control requirements and identify strategies to achieve project and business goals with moderate guidance. 
 

Principal Responsibilities Cont.

•    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 moderate guidance. 
•    Effectively establish validation and development plans of moderate complexity with a minor level of guidance. 
•    Ensure Teleflex Medical OEM suture products meet customer and quality system requirements. 
•    Support and lead 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.
•    Assist in establishing continuous improvement initiatives and methods of application.
•    Utilize understanding of medical device development and product line fundamentals to develop project strategies of moderate complexity. 
•    Ensure projects are developed and documented compliant with the Quality System.
•    Collaborate to develop quality assurance, testing, regulatory compliance, and quality plans.
•    Lead and support design control reviews with minimal guidance.
•    Support and/or lead 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.
•    Minimum 2 years of experience in medical device or related field (3+ years preferred). 
•    Minimum of 2 years of experience successfully leading projects and/or project deliverables (3+ years preferred).
•    Good understanding of U.S. FDA GMP and ISO requirements for the design, validation, and manufacturing of medical components and/or devices.
•    Experience with customer facing interaction is highly preferred.
•    CAPM or PMP certification is a plus.
 

Specialized Skills / Other Requirements

•    Has practical experience of product creation, and process/product transfer. 
•    Is able to apply project management skills and tools effectively to successfully complete projects of varying complexities with a moderate level of guidance.
•    Demonstrates ability to identify and anticipate challenges and/or opportunities. 
•    Shows good working knowledge of project management tools and skills. 
•    Can successfully manage projects of moderate scope with minimal guidance.
•    Can Identify and demonstrates clear ownership of tasks and takes responsibility for outcome
•    Positive attitude and actively looks to take ownership and responsibility without being prompted. 
•    Skilled at constructive collaboration with colleagues across different areas.
•    Demonstrates skills in positively resolving conflict.
•    Can effectively communicate with internal and external customers, showing sound judgement as to when support is needed.
•    Ability to execute a validation strategy for a new product or process per Quality System requirements.
•    Strong customer interaction skills, ability to interface independently with customer representatives and present Capable of delivering setbacks and constraints in an open and transparent manner.
•    Exhibits the determination and curiosity to solve multi-factorial problems. Employs a systematic structured approach to problem solving.
•    Capable of coaching and/or mentoring peers in areas of expertise.
•    Demonstrates customer focus in daily activities, problem solving and solution development.
•    Demonstrates creative thinking when approaching a task.
•    Has an understanding of the quality system and general regulatory requirements in the field.
•    Experience with Microsoft Office – PC, Word, Excel, PowerPoint, Project (or similar).

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