Product Development Engineer
Posted on: June 12, 2021
Date: May 16, 2021
Location: Mansfield, MA, US
Expected Travel: Up to 25%
Requisition ID: 3401
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'
The Product Development Engineer is responsible for management,
execution and oversight of Product Development and sustaining
projects within the OEM Performance Fibers business unit. They must
be capable of effectively leading projects ranging from minor to
high complexity with minimal supervision. The Product Development
Engineer is expected to have a strong knowledge of Design Control
methods, medical device regulations and project management
principles. They will be expected to successfully carry out
projects and deliverables across cross-functional teams and
multiple facilities, with a focus on quality, compliance, and
The scope of products for which the Product Development Engineer
will be responsible for developing and sustaining includes, sterile
and non-sterile suture components, contract manufactured suture
products, and sterile suture devices for the Mansfield, MA and
Coventry, CT Facilities.
- Plan, lead, and execute Product Development and sustaining
projects, including those which are highly complex, with minimal
supervision and a high level of independence.
- Develop custom devices, sutures and subassemblies according to
customer design, performance, and quality specifications; on time
and within project constraints.
- Interface with cross-functional teams to maintain
accountability, coordinate and execute deliverables supporting new
product and capability development projects, sustaining projects,
and other initiatives.
- Apply structured project management principles such as scope
definition, timeline development, contingency planning, risk
planning and mitigation, stakeholder analysis, et cetera, to plan,
lead and execute projects of low to high complexity.
- Accurately predict project requirements, costs, lead times, and
delivery schedules during the quoting and project execution
- Review and prepare status reports, modify schedules, and
project plans as required.
- Manage stakeholder communication to ensure project status
and/or related issues are effectively communicated. Collaborate
with sales and customer care to support customer
- Serve as technical resource to sales, Quality, Regulatory,
Marketing and Customer Care.
- Serve as subject matter expert (SME) in design control and
product capabilities to effectively lead and support Performance
Fibers projects and initiatives.
- Ensure Teleflex Medical OEM suture products meet customer and
quality system requirements.
- Provide technical leadership, lead root cause analysis and
customer or project-related problem resolution activities;
materials, assembly, functional, or manufacturing related.
- Generating and developing protocols, reports, and studies,
including verification and validation testing. Supports engineering
and cross-functional teams in protocol and study-related strategy
- Lead and support proper creation and maintenance of drawings,
procedures, design documents (DFMEA, FMEA, Traceability Matrix,
etc) technical documentation.
- Ensure projects are developed and documented compliant with the
- Collaborate to develop quality assurance, testing, regulatory
compliance, and quality plans.
- Lead and participate in design and technical phase
- Adhere to and ensure the compliance of Teleflex's Code of
Conduct, all Company policies, rules, procedures and housekeeping
- Serve as central contributor to identification and execution of
continuous improvement initiatives.
- Utilize and integrate lean principles within project, process,
and resource management activities, acting as a catalyst for
- Employ an entrepreneurial spirit and mindset to support growth
of the team and business.
- Empower team members and cross-functional teams to use critical
and creative thinking to identify opportunities to act
independently and initiate change.
Education / Experience Requirements
- Bachelor of Science in an Engineering or related technical
- Minimum of 5 years of experience in medical device or related
- Minimum of 5 years of experience successfully leading projects
and/or project deliverables.
- Knowledgeable in U.S. FDA GMP and ISO requirements for the
design, validation, and manufacturing of medical components and/or
- Experience with EU MDR regulations and/or compliance projects
is highly preferred.
- PMP certification is preferred.
Specialized Skills / Other Requirements
- Working knowledge of project management principles and
- Working knowledge of international regulations, requirements
and/or ISO 13485 quality systems.
- Strong interpersonal skills that include working well in a team
environment with the ability to effectively lead and manage
- Effective written and oral communication skills.
- Focus on detailed work with emphasis on accuracy and
- Excellent organizational and planning skills; drives for
- Effective analytical/problem-solving skills.
- 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.
- 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 , Product Development Engineer, Other , Mansfield, Massachusetts
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