Sr. Engineer, Development

Position Summary

The Sr. Engineer, Development  is responsible for leading and overseeing Development projects of varying complexity 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 Development projects with a high level of independence. They are also responsible for establishing and supporting manufacturing operations including the validation of new equipment and materials, troubleshooting development processes, as well as identifying and implementing process/product improvements within development activities. The engineer will work with cross-functional teams to, resolve material issues, customer complaints, design and develop new product, and review potential new business opportunities.
The Sr. Engineer, Development is expected to have a high level of proficiency in Design Control and development methods, manufacturing methods, medical device regulations, and project management. They will be expected to successfully carry out and support complex project deliverables/Development functions with a focus on quality, compliance, and customer satisfaction. May be responsible for the management of direct reports. Is seen as a leader and Subject Matter Expert within the Development team.
The scope of products for which the Sr. Engineer, Development will be primarily responsible for developing and 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

•    Apply complex project management principles to plan, lead and execute projects of low to high complexity independently.
•    Lead quoting exercises such as component sourcing, identification of project deliverables and risks, and timeline estimation, of low to high complexity independently.
•    Review and prepare status reports, modify schedules, and project plans of high 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.
•    Utilize and integrate lean principles within project, process, and resource management activities, acting as a catalyst for initiating change.
•    Serve as subject matter expert (SME) in design control and product capabilities to effectively lead and support Performance Fibers projects and initiatives. 
•    Work on complex, high impact, issues and challenges where broad holistic analysis of a situation or data is required.
•    Establish new and/or improved processed based on changing regulations, or remedial activities to ensure compliance with regulatory and Quality System requirements.
•    Ensure Teleflex Medical OEM suture products meet customer and quality system requirements. 
•    Provide technical leadership, lead root cause analysis, NC’s, CAPA’s and customer or project related problem resolution activities; materials, assembly, functional, or manufacturing related.
•    Understand design control requirements and identify strategies to achieve project and business goals with moderate guidance. 
•    Serve as Subject Matter Expert in Teleflex suture products.
•    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 independently.
•    Provide guidance and leadership in Development and other cross functional groups on development and/or business practices. 
•    Effectively establish validation and development plans of high complexity, independently. 
•    Utilize methods of Lean/6σ and other continuous improvement methods for factory improvement programs such as Enterprise Excellence.
•    Ensure Teleflex Medical OEM suture products meet customer and quality system requirements. 
•    Coordinate and support proper creation and maintenance of drawings, procedures, design documents (DFMEA, FMEA, Traceability Matrix, etc) as well as other technical and manufacturing documentation.
•    Assist in developing strategies for growth of Development team and/or capabilities.
•    Can act independently to establish new processes, method and techniques.
•    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.
•    Represent Teleflex Medical OEM on calls in relation to major internal and external opportunities as an SME.
•    Support and/or lead EPIC Medtech customer visits and development activities as needed.
•    Overall management of direct reports (as appliable).
•    Support the individual development of direct reports (as appliable).
•    Coach and mentor direct reports (as applicable) and peers in challenges and opportunities for learning to support overall team/value stream success.
•    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 6 years of experience in medical device or related field (7+ years preferred). 
•    Minimum of 6 years of experience successfully leading projects and/or project deliverables (7+ years preferred). 
•    2+ years leading teams is highly preferred.
•    Knowledgeable in U.S. FDA GMP and ISO requirements for the design, validation, and manufacturing of medical components and/or devices.
•    Experience with customer facing interaction.
•    PMP certification or advanced degree is a plus

Specialized Skills / Other Requirements

•    Is able to manage challenges and opportunities which arise within the Value Stream effectively and uses good judgement as to when escalation is appropriate.
•    Can effectively manage multiple reports (as applicable), shows strong people development skills and has shown the ability to support, guide and grow people within their team. 
•    Provides high level of guidance to less senior engineers and is able to address challenges and identify/act upon opportunities at a Value Stream level with minimal guidance from leadership.
•    Can effectively and successfully organize, lead and manage complex projects/programs with a high level of independence. 
•    Serves as lead in identifying and implementing new systems and continuous improvement initiatives.  Actively anticipates organizational needs and can organize effort beyond themselves to address them.
•    Is well versed in appropriately applying project management tools to projects and sets project management standard for team and peers.
•    Operates with a high level of autonomy level to meet individual, team, and organizational goals. 
•    Is able to guide team/peers effectively and demonstrate logic/justification for proposed action to team and leadership.  
•    Uses expertise to contribute to organizational action and strategy.
•    Automatically takes ownership for the outcome and informally works with peers and associates to ensure the outcome occurs on the company's behalf. 
•    Takes a strong role as a team leader and helps to coach desirable collaboration skills within team.
•    Demonstrates skill in positively resolving conflict in individual, group settings, and within direct team (reports).
•    Effectively communicates in high visibility situations with a strong sense of the audience.  Sets the standard for effective communication with internal and external customers.
•    Able to utilize critical thinking to develop complex validation strategies and innovate methods of execution.
•    Highly developed skills in managing customer interactions/communications & inquiries. Is able to coach and develop communication strategies into the team.
•    Capable of quoting and coordinating quoting efforts across a group of engineers for programs of high complexity. 
•    Consistently uses entrepreneurial thinking when approaching quoting and can identify opportunities for innovating how we do business.
•    Exhibits the determination and curiosity to solve problems. Employs a systematic structured approach.
•    Capable of coaching and mentoring cross functional teams in areas of expertise. Demonstrates strength in ability to share skills and mentor peers/team members.
•    Thinks like a business owner. Starts conversation from the perspective of what is best for the business.
•    Has a strong functional background of working within quality systems in the field and can effectively support the system through leading the team/peers.
•    Experience with Microsoft Office – PC, Word, Excel, PowerPoint, Project (or similar).

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Working Conditions / Physical Demands

The pay range for this position at commencement of employment is expected to be between (146,100-219,200)  however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience.  The total compensation package for this position will also include benefits such as medical, prescription drug, dental and vision insurance, flexible spending accounts, participation in 401(k) savings plan, and various paid time off benefits, such as PTO, short- and long-term disability and parental leave, dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment.