Sr. Manager, Process & Design Dev Eng, R&D - Chelmsford, MA

Teleflex•Chelmsford, MA

57d•$168,000 - $252,000•Onsite

About The Position

The Sr. Manager, Process & Design Engineering, will lead a team of engineers that provide process and design engineering expertise for the IAB Catheter portfolio within Acute Care. Portfolio engineering activities include new product and process development, sustaining engineering projects, and product and process improvements and remediation. The Sr. Manager is expected to partner with R&D Systems & Software Engineering teams for the IAB pump, Acute Care Senior Leadership Team, Regulatory, Quality, Operations, Marketing, Sales, Field Service, Clinical & Medical Affairs (CMA), and other extended teams to drive the successful identification, planning and execution of R&D projects focused on the IAB Catheters.

Requirements

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
Excellent analytical and problem-solving skills, familiarity with statistical techniques, experience with scientific methods and Design of Experiments
Very strong interpersonal and communication skills; proficient in leading teams as well as influencing cross-functionally resulting in the ability to gain alignment and drive consensus on project decisions
Expertise in project technical leadership with the ability to oversee multiple projects simultaneously
Ability to understand and resolve complex technical and business system issues
Ability to coach and mentor managers, engineers, project management colleagues and other professionals
Proficiency in MS Office applications, strong written and verbal communication skills, ability to read and understand technical drawings, product requirements and specification documents
Flexible and adaptable; excellent time management and capable of prioritizing for timely execution
Ability to travel domestically

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 individual 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