Sr. Engineer, Development

About the role

The Sr. Engineer, Development is responsible for leading and overseeing Development projects of varying complexity within the OEM Performance Fibers (sutures) business unit. They lead and support Development projects with a high level of independence, manage stakeholder communication, and serve as a Subject Matter Expert (SME).

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.
• 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.
• 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.
• Support the individual development of direct reports (as applicable).
• Support the development of strategies for growth of Development team and/or capabilities.
• Support the development of 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 applicable).
• Coach and mentor direct reports (as applicable) and peers in challenges and opportunities for learning to support overall team/value stream success.

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.

Specialized Skills / Other Requirements

• Able to manage challenges and opportunities which arise within the Value Stream effectively and uses good judgement as to when escalation is appropriate.
• Shows strong people development skills and has shown the ability to support, guide and grow people within their team.
• Guides team/peers effectively and demonstrates 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.
• Utilizes critical thinking to develop complex validation strategies and innovate methods of execution.
• Highly developed skills in managing customer interactions/communications & inquiries. Coaches and develops communication strategies into the team.
• Captures and coordinates quoting efforts across a group of engineers for programs of high complexity.
• Approaches quoting with entrepreneurial thinking and identifies opportunities for innovating how we do business.
• Solves problems with a systematic structured approach.
• Coaches and mentors cross functional teams in areas of expertise. Demonstrates strength in ability to share skills and mentor peers/team members.
• Starts conversations from the perspective of what is best for the business.
• Works within quality systems in the field and supports the system through leading the team/peers.

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, details of participation in these benefit plans will be provided if an employee receives an offer of employment.

Application Instructions

At Teleflex, we follow a comprehensive hiring process. We do not accept unsolicited resumes from agency recruiters or 3rd party firms. We do not make unsolicited job offers. We do not ask for money or require equipment purchase up-front.