Senior Manager, Process & Design Engineering – IAB Catheters

Teleflex; Chelmsford (MA); On-site; USD 168,000 - 252,000; Full time

Job summary

Teleflex is seeking a Sr. Manager, Process & Design Engineering, R&D in Chelmsford, MA to lead a team delivering process and design engineering for the IAB Catheter portfolio within Acute Care.

You’ll partner with R&D, regulatory, quality and operations to drive development, synthesis of plans, and successful project execution across multiple products. The role requires a bachelor’s in engineering, 8+ years of regulated-industry experience, and strong leadership with DOE, IQ/OQ/PQ, and design

Qualifications

• Minimum education engineering/technical bachelor’s degree, advanced degree preferred.
• Minimum 8 years of related experience.
• Medical Device, Pharmaceuticals or other highly regulated industry experience required.
• Expertise in process validation (IQ, OQ & PQ), experience with development of processes through various stages of the product development cycle.

Responsibilities

• Manage the team responsible for design, development and implementation of new/modified products, processes, equipment and verification methods for IAB catheters.
• Drive data informed decisions to improve catheter manufacturing processes in collaboration with Operations and Quality teams.
• Coordinate, direct, and execute systematic development activities such as product design improvements, process characterization, DOEs and validation builds.
• Identify, specify and coordinate development, sourcing and qualification of equipment, tooling, fixtures and materials to produce product per design specifications.
• Serve as a product expert/SME as required; Coach/mentor best practices across the design, development and sustaining activities to strengthen R&D departmental competencies.
• Oversee multiple complex projects while providing supervision and guidance to technical personnel.
• Provide input to project plans and timelines. Track project progress and communicate project status to management and project leader as applicable.
• Write, review and/or approve technical documentation (plans, protocols, reports, FMEAs etc.) in support of design and process changes.
• Conduct and oversee Risk Analyses, Root Cause investigations, design-related NC & CAPAs as needed.
• Develop skills and expertise for individal team members via a mix of coaching, training and mentoring to address gaps in process development and technical leadership.
• Actively participate in department strategic and budgetary planning.
• Plan organizational resources and budget to support business initiatives.
• Oversee the core team member(s) allocated to the manufacturing transfer of new products from R&D or existing products to other manufacturing locations.
• Ensure resource commitments, operational deliverables and readiness measures are incorporated in the project plans, and risks are clearly identified. Work closely with the Global Supply Chain/Operation leaders, where applicable.
• Ensure projects are developed and documented compliant with Teleflex’s Quality system.
• Adhere to and ensure the compliance of Teleflex’s Code of Ethics, all Company policies, rules, procedures and housekeeping standards.

Skills

Analytical skills

Problem solving

Leadership

Cross-functional collaboration

Communication

Project management

Technical reading

Travel readiness

Education

Bachelor's degree in engineering/technical field

Advanced degree preferred

Tools

MS Office

Job description

Teleflex is seeking a Sr. Manager, Process & Design Engineering, R&D in Chelmsford, MA to lead a team delivering process and design engineering for the IAB Catheter portfolio within Acute Care.

You’ll partner with R&D, regulatory, quality and operations to drive development, synthesis of plans, and successful project execution across multiple products. The role requires a bachelor’s in engineering, 8+ years of regulated-industry experience, and strong leadership with DOE, IQ/OQ/PQ, and design