Creganna Medical Devices provides catheter shaft components, sub
assemblies and a design service in a range of metals, polymers and composite
materials. Creganna is a leading supplier to
the world’s largest minimally invasive medical device companies. Our Marlborough, Massachusetts facility is dedicated to Design
Services, Extrusion and Needle based products. We have an exciting
expansion program and are looking for the following position:
Senior Design Engineer
SUMMARY:
The Senior Design Engineer will be responsible for
developing and managing projects. This position requires a candidate with
extensive product development experience in the medical device arena, and one
who will be comfortable operating across senior levels in the organization.
DUTIES And Responsibilities:
- Be
primary customer contact person responsible for managing the development
process from concept generation through manufacturing, in addition to
being technical lead to optimize product design.
- Manage
and develop intellectual property generated by development
activities.
- Apply
new and existing technologies to provide the optimum solutions to meet the
customer’s requirements.
- Cultivate
relationships with customers to obtain repeat business.
- Maintain
product files and other relevant documentation to comply with quality
standards.
Key Requirements:
- 5+
years industry experience in a medical product development environment.
- An
engineering degree, or equivalent, ideally with Master’s qualification.
- Proven
project management skills and experience, including design control
procedures and Medical Device regulatory procedures.
- Knowledge
of minimally invasive Medical Device design, development and
manufacturing.
- Experience
in performing FMEA’s, verifications and
validations for medical devices products and processes.
- Knowledge
and experience with Medical Device sterilization processes, specifically
gamma and EtO sterilization.
- Experience
with engineering tools such as DOE and SPC.
- Experience
in requirements for GLP, GMP environments.
- 3D
modelling experience.
- Working
knowledge of biocompatible metal and polymer materials.
To apply contact:
hrusa@creganna.com
www.creganna.com