Candidate will be responsible for the successful design and development of disposable medical device products, fixtures, and packaging. This position will have project management responsibilities for multiple products in different phases of development. Strong communication, planning, organization, and leadership skills are required.
Principle Duties and Responsibilities:
Responsible for the design of medical device products from concept through development, testing, and manufacturing scale-up.
Design of complex high volume injection molded plastic parts and assemblies using Solidworks, FEA, and strong electro-mechanical fundamentals.
Strong understanding and experience with material selection in applications that must meet challenging requirements such as high stress, fatigue, creep and sterilization compatibility.
Project Management responsibilities will include vendor and supplier management, directing design and test technician resources.
Fabricate concept and working prototypes with the use of in-house manufacturing and external rapid prototype sources.
Interface with Quality Assurance, Operations, Marketing, Vendors, Customers and Physicians.
Work with internal and external manufacturing partners to ensure producible designs.
This is a 6+ months contract to hire position.
Skills/Requirements
High School graduate or equivalent is required. Associate Engineering degree preferred.
5 years’ experience in R&D, Engineering, or Product Development.
3+ years’ experience with Medical Device Design is preferred.
Experience with disposable medical device technologies, design, verification testing, design/process validation and manufacturing
Familiarity with plastic processing methods such as injection and over molding, extrusion, RF and ultrasonic welding, tipping, forming, and adhesive bonding
Experience in medical device design control procedures or other highly regulated environments
Perform design trade-offs for performance, form factor, cost, schedule and risk
Create solid models and drawings with familiarity with PDM system integration
Working knowledge of applicable drafting standards (ANSI & ISO) a plus
Ability to identify and execute analytical studies using FEA, mold-flow, stack-up analyses, and GD&T
Strong knowledge of polymer material selection, medical grade plastics and elastomers a plus.
Proficient in Microsoft Office Suite. Working knowledge of SAP desired.
Some travel may be required.
ABIOMED is an Equal Employment Opportunity/Affirmative Action employer. We are committed to the policy of providing equal employment opportunities without regard to race, color, religion, sex, sexual orientation, gender identity, veteran status, disability, national origin.
