Posted on: June 12, 2021
Date: May 20, 2021
Location: Mansfield, MA, US
Expected Travel: None
Requisition ID: 3473
About Teleflex Incorporated
Teleflex is a global provider of clinically effective medical
technologies designed to improve the health and quality of people's
lives. We apply purpose driven innovation - a relentless pursuit of
identifying unmet clinical needs - to benefit patients and
healthcare providers. Our portfolio is diverse, with solutions in
the fields of vascular and interventional access, interventional
cardiology, surgical, anesthesia, cardiac care, interventional
urology, urology, emergency medicine and respiratory care. Teleflex
employees worldwide are united in the understanding that what we do
every day makes a difference. For more information, please visit
OEM - Teleflex Medical OEM is a leading global provider of
product development and production services for medical device
manufacturers. We set ourselves apart with deep expertise, decades
of experience, a dedication to design for manufacturability, and
extensive, in-house capabilities, which include engineering,
regulatory services, material selection and formulation,
prototyping, manufacturing, assembly and packaging. We deliver
industry-changing innovations and next-generation solutions for
extrusions; diagnostic and interventional catheters; balloons and
balloon catheters; sheath/dilator sets; specialty sutures, braids
and fibers; and bioabsorbable sutures, yarns and resins. Join a
dynamic, growing team that offers healthcare providers an array of
medical technology solutions that make a difference in patients'
This Mansfield, MA based Sustaining Engineer is responsible for
the execution of product performance testing and design control
deliverables associated with design file remediation and sustaining
projects to meet European Union Medical Device Regulation (MDR)
requirements. This position interfaces with crossfunctional teams
to complete sustaining projects, design control deliverables, and
activities to ensure Teleflex Medical OEM suture products meet
evolving standards in the European Union (EU). Products will
include EU Class IIb and III devices. Scope of projects will also
include sustaining and remediation activities to ensure proper data
is on file to support EU MDR information required by contract
manufactured, sterile and non-sterile component customers.
- Plan and execute activities to update and sustain Tech Files
and Design Dossiers in preparation for new MDR regulations.
- Management and coordination of multiple EU MDR deliverables to
ensure tasks are completed to meet target dates as defined by the
EU MDR Progam Manager and BU Regulatory lead.
- Provide progress updates on the assigned MDR compliance
projects to OEM cross functional teams and leadership.
- Planning and execution of deliverables/projects to identify and
remove hazardous substances as defined by EU/MDR 2017/745.
- Interface with Suppliers, Customers,Purchasing, Quality,
Marketing and Regulatory Affairs to deliver projects.
- Coordinate with and support Purchasing in supplier related MDR
- Plan and lead the verification and validation activities for EU
MDR remediation, and/or new/replacement materials as per product
- Work in conjunction with Regulatory lead to obtain additional
MDR training, as needed.
- Ensure consistency in approach of assigned MDR remediation and
- Execution of project risk planning and response
- Coordinate and implement laboratory testing, data analysis and
preparation of technical reports as required by the project
- Execute development/improvement of products and processes,
optimize by utilizing tools such as DOE, accomplish their
evaluation through verification and validation.
- Interface with suppliers to obtain information required to
update Tech Files and DHF documentation.
- Interface with purchasing and Sales Ops to support development
of customer and supplier agreements as they relate to EU MDR
- Support Product Development activities such as Change Order
management, protocol generation, test execution, as needed.
- Lead and participate in design and technical phase
- Ensure projects are developed and documented compliant with the
- Adhere to and ensure the compliance of Teleflex's Code of
Conduct, all Company policies, rules, procedures and housekeeping
Education / Experience Requirements
- Bachelor's Degree required. Engineering or technical discipline
- Minimum 2-3 years of previous experience in related field (e.g.
medical device or component manufacturing, product development and
manufacturing processes, regulated industry)
- Minimum 1-3 years of previous experience successfully leading
projects and project deliverables.
- U.S. FDA GMP and ISO requirements for the design, validation,
manufacturing processes, secondary operations and assembly of
medical components and devices preferred
- Knowledge of and experience with EU MDR regulations and/or
compliance projects is highly preferred
- PMP certification is preferred
Specialized Skills / Other Requirements
- Focus on detailed work with emphasis on accuracy and
- Effective written and oral communication skills
- Excellent organizational and planning skills; drives for
- Effective analytical/problem solving skills
- Strong interpersonal skills that include working well in a team
environment with the ability to effectively lead others
- Ability to exercise reasonably independent judgment and
discretion within a defined range of policies and practices
- Ability to handle multiple tasks and to prioritize/schedule
work to meet business needs with routine supervision
- Working knowledge of international regulations, requirements
and/or ISO 13485 quality systems
- Proficient in Microsoft Office - PC, Word, Excel, PowerPoint,
Project (or equivalent)
Teleflex, Inc. is an affirmative action & equal opportunity
employer. D/V/M/F. Applicants will be considered without regard to
age, race, creed, color, national origin, ancestry, marital status,
affectional or sexual orientation, gender identity or expression,
disability, nationality, sex, or veteran status. If you require
accommodation to apply for a position, please contact us at:
Teleflex is the home of Arrow, Deknatel, Hudson RCI, LMA,
Pilling, Rsch, UroLift and Weck - trusted brands united by a common
sense of purpose. Teleflex, the Teleflex logo, Arrow, Deknatel,
Hudson RCI, LMA, Pilling, Rsch, UroLift and Weck are trademarks or
registered trademarks of Teleflex Incorporated or its affiliates,
in the U.S. and/or other countries.
Keywords: Teleflex, Boston , Sustaining Engineer, Other , Mansfield, Massachusetts
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