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

Position Summary

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. 

Principal 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

Education / Experience 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

Specialized Skills / Other Requirements

•    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

The pay range for this position at commencement of employment is expected to be between $168,000 - $252,000, 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.
 
If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.

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Working Conditions / Physical Demands

TRAVEL REQUIRED: ~10 %

WORKING ENVIRONMENT:
☒ Office/Professional        ☒ Plant/Manufacturing    ☐ Remote/Field     ☒ Laboratory