R&D Engineer I
Abbott Laboratories
Plymouth, MN
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 103,000 colleagues serve people in more than 160 countries.

Position Summary:
We are recruiting for our next R&D Engineer I to join our team. In this role, you are ensuring that new and/or modified products conform to requirements and establishing compliance within the quality system. You will be performing engineering testing and data analyses that will support changes to and improvements in the risk management documentation including: DFMEA, UFMEA, PFMEA.

Primary Responsibilities:
Under the guidance from a Senior Engineer, generating design improvement concepts to meet specific design goals
Involved in test method and model development
Identify potential issues with designs
Work with internal departments and outside vendors to obtain prototype parts
Support invention disclosures
Support pre-clinical and clinical testing of devices
Support design reviews and physician visits
Execute activity in support of project goals
Gain an understanding of the quality and regulatory requirements of SJM, FDA and ISO regulations
completion of assigned tasks
Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.
Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors
Performs other related duties and responsibilities, on occasion, as assigned

Required Qualifications:
Bachelor’s degree in Mechanical Engineering or related field
1+ year experience designing, testing, manufacturing or other engineering support
Experience working within a team and as an individual contributor in a fast-paced, changing environment
Strong verbal and written communications with ability to effectively communicate to all levels of the organization
Proficient in collaborating with project stakeholders (client and internal), end-users, business partners, and technical team members
Multitasks, prioritizes and meets deadlines in timely manner
Strong organizational and follow-up skills, as well as attention to detail

Preferred Qualifications:
1+ year medical device experience (full-time, internship, or combination)
Exposure to a variety of manufacturing processes used in medical devices, specifically deflectable sheaths and/or EP Catheters preferred
Solidworks or other CAD experience
Worked with an electronic document control system (Windchill, etc.)
Experience working with cross-functional teams in a geographically diverse, matrixed organization