Principal Catheter Development Engineer Job Listing at Accellent Inc. in Wilmington, MA (Job ID accellent-2316)

Accellent Inc.

Location: Wilmington, MA
Application deadline: None
Type: Not specified
Career Level: Not specified
Salary Range: Not specified
Number of Jobs: 1
Relocation Available: No
Show all jobs for Accellent Inc.
Health Products & Services
Principal Catheter Development Engineer

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Job Description

Accellent, Inc. is a fully integrated provider of design, supply chain management and strategic sourcing services to the Medical Device industry., a recognized market leader, is a fast-growing outsource manufacturing and design solution company specializing in high growth areas such as Cardiology, Endoscopy and Orthopaedics. The top Medical Device companies partner with Accellent to provide innovation, advanced technology, speed to market, low cost labor and strategic sourcing. 


The Principal Catheter Development Engineer is responsible for catheter development projects in the Wilmington (Massachusetts) Idea Center (WIC) with the goal of transferring catheter production to Accellent manufacturing facilities.




* Ownership of the catheter product development process from initial prototypes to transfer to production, including:
* Establishing a relationship with the customer to understand product requirements, test and sample needs, launch timelines, and collaborate on the design configuration to achieve the intended clinical use
* Translating the customer product performance needs into an executable tool box based design.
* Establishing the tool box details of materials, sizes, braid configurations, construction methodologies, etc.. using the Virtual Tube Model , real world, experience , predicate devices, customer provided design information and other tools as appropriate.
* Execution of prototype builds including:
* Establishing a DMR and lot history record that is appropriate for the phase of the development effort.
* Establishing test plans, test methods and executing testing to obtain quantitative data on the device performance for various design configurations.
* Developing process s and tooling as needed to create a robust assembly that meets the product performance and cost targets. Includes continuous incorporation of DFM to support a seamless transfer to manufacturing
* Building of the devices with and without technician support.
* Providing direction to the technicians to enable them to execute testing and builds.
* Documentation of testing results in a manner that can enable data driven decisions with the customer and capture lessons learned for our engineering team and the receiving facility
* Follow up communications with the customer throughout the design – build –test loop to rapidly converge the design to a robust solution, including incorporating customer testing results and design work back into the toolbox based designs.
* Communication with the receiving facility team and establishment of a transfer plan to prepare for launch.
* Transferring a robust assembly process in the timeline required by the customer to the receiving facility that successfully passes PQ and meets or exceeds the cost and quality targets.
* Executing with a rapid development mind set that utilizes a design tool box to enable rapid iterations of many design concepts that is driven by data based information
* Responsible to establish a core development competency for Accellent in the design, fabrication and assembly of catheter products used in various medical applications, including but not limited to:
-         Electrophysiology catheters

* AF Catheters; Renal Denervation
-         Steerable catheters

-         Self expanding delivery systems

* Stents, Heart valves, Filters
-          Microcatheters

*  Neurovascular devices; Embolization delivery devices
-          Guide catheters


* Responsible to identify, justify, specify, commission, implement and stabilize appropriate technologies, processes, equipment and assembly skills, within budgetary guidelines, to meet customer and product needs including, but not limited to:
-         Braiding, RF welding and tipping; thermal tipping, bonding and fusing; shaping and forming; drilling; marker band and electrode placement; neck down; insert molding; skiving; hydrophilic coating; and packaging    

* Provide Applications Engineering with sufficient information for the AE team to develop accurate and thorough costs for quotes.
* Work collaboratively with other functions; engineering, quality, customer solutions, finance, and sales to successfully and seamlessly deliver to customers an integrated set of services and products.
* Be a resource to other members of the Accellent Team, with a responsibility to educate people about technology developments, constraints and opportunities.
* Comply with all work rules including those pertaining to safety, health, quality and Accellent Quality Management System.
* Perform other duties as necessary.

Required Experience



* Educational:
-         4 year College degree, preferably within a technical, engineering, and/or plastics discipline

-         5-10 years medical device engineering, manufacturing and/or assembly experience, with a very strong preference for specific experience in the area of catheter fabrication and related process technologies

-         3-5 years leadership experience, including management responsibility, with a hands-on world-class manufacturing orientation. (Principal Level Requirement)

-         Deep understanding of medical device assembly value drivers. Has developed and executed shop floor manufacturing plans.

-         Exceptional performance track record (with references).

-         Passion for developing people, with associated understanding of required patience; takes pride in the success of others on the team.

-         Rational thinker: good business judgment.

-         High energy, passionate, honest and open style, team-player.

-         Positive attitude and leader of people in a world-class assembly setting.

* Technical:
-         Leadership/Supervision

-         Ability to interface and communicate with people effectively and efficiently

-         Experienced with computers and computer software to effectively complete job requirements

-         Must be able to develop, read, and interpret technical specifications and illustrations

-         Demonstrated organizational skills including project scheduling

* Performance:
-         Passion for developing people, with associated understanding of required patience; takes pride in the success of others on the team.

-         Rational thinker: good business judgment.

-         High energy, passionate, honest and open style, team-player.

-         Positive attitude and leader of people in a world-class setting.





Accellent is an Equal Opportunity/Affirmative Action employer and we value diversity in our workforce. As such we provide equal opportunity for all applicants without regard to race, religion, gender, national origin, age, marital status, veteran status, or disability. To learn more about Accellent and our career opportunities, please visit us 



Job Location
Wilmington, Massachusetts, United States
Position Type

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