Sr. Manager, Process & Design Dev Eng, R&D - Chelmsford, MA
Leads a team of process and design engineers for Teleflex's intra-aortic balloon (IAB) catheter portfolio, driving new product/process development, manufacturing improvements, validation builds, and risk/root-cause work in a regulated medical device R&D environment. Core focus areas include process validation (IQ/OQ/PQ), design of experiments, statistical methods, and cross-functional project lead
Medical Device, Pharmaceuticals or other highly regulated industry experience
Expertise in process validation (IQ, OQ & PQ) and process development across product development cycle
Excellent analytical and problem-solving skills; familiarity with statistical techniques, scientific methods and Design of Experiments
Very strong interpersonal and communication skills; able to lead teams and influence cross-functionally
Expertise in project technical leadership, overseeing multiple projects simultaneously
Ability to understand and resolve complex technical and business system issues
Ability to coach and mentor managers, engineers and project management colleagues
Proficiency in MS Office; ability to read technical drawings, product requirements and specification documents
Flexible and adaptable with excellent time management and prioritization
Ability to travel domestically (~10%)
Full description
Expected Travel: Up to 10%
Requisition ID: 14395
About Teleflex Incorporated
As a global provider of medical technologies, Teleflex is driven by our purpose to improve the health and quality of people’s lives. Through our vision to become the most trusted partner in healthcare, we offer a diverse portfolio with solutions in the therapy areas of anesthesia, emergency medicine, interventional cardiology and radiology, surgical, vascular access, and urology. We believe that the potential of great people, purpose-driven innovation, and world-class products can shape the future direction of healthcare.
Teleflex is the home of Arrow™, Barrigel™, Deknatel™, LMA™, Pilling™, QuikClot™, Rüsch™, UroLift™ and Weck™ – trusted brands united by a common sense of purpose.
At Teleflex, we are empowering the future of healthcare. For more information, please visit teleflex.com.
Acute Care - The Acute Care division of Teleflex is dedicated to empowering healthcare professionals with industry-trusted devices that advance the practice of anesthesia and respiratory care. Our portfolio includes LMA™ Airways, Rüsch™ Laryngoscopes, Rüsch™ and Sheridan™ Endotracheal Tubes, and Arrow™ Pain Management—products designed to provide reliability, performance, and clinical value. Built on a foundation of quality and innovation, our solutions support clinicians across a wide range of care settings, including emergency prehospital environments, hospitals, and procedural settings. Each product is developed with a focus on patient safety, ease of use, and consistency, helping providers respond effectively to evolving clinical demands. Join a dynamic, growing team that offers healthcare providers advanced medical technology solutions that make a difference in patients' lives.
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
Sr. Manager, Process & Design Dev Eng, R&D - Chelmsford, MA at Teleflex — aijobsearch
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
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
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.
Teleflex Incorporated is an equal opportunity employer. Applicants will be considered without regard to age, race, religion, color, national origin, ancestry, sexual orientation, disability, nationality, sex, or veteran status. If you require accommodation to apply for a position, please contact us at: 877-880-8588 or Talent@Teleflex.com.