§ Mechanical Engineer or Bioengineering degree
§ Medical device experience (especially single use disposables)
§ Lab experience
o Testing of medical devices
o Testing of single-use disposables
o Designing / using jigs and test fixtures
§ Protocol and report writing
§ Data analysis
§ Failure investigation for unexpected test results
§ Verification and validation testing experience
§ History of ownership / initiative / empowerment to drive the project forward. (not just execution of pre-planned work)
What are the top three technical skills this person should have? Desired to have background in Mechanical Aptitude (application of scientific principles), Design Controls, Material Science, External Contractor Manufacturing Experience
What are the top three soft skills this person should have? Critical thinking, collaboration, sense of urgency and drive for results.
What is the preferred experience level you want (years)? 1-3 yrs
Any specific education or certifications? Desired to have BS Mechanical Engineering or Technical degree
o Any chance for remote work at all? 100% onsite
What is the expected interview process? Phone and in person? Phone
Description
Engineer II
Summary
Responsible for designing, developing, implementing and evaluating optimal, cost-effective projects and technologies. In addition to providing technical support and service to these areas, the incumbent may also perform the following functions: supervising, requisitioning, defining, initiating, specifying, documenting and training.
Responsibilities
1) Act independently with minimal supervision to conduct smaller approved projects. Expected to make suggestion on improvements based on recent technical knowledge.
2) Able to contribute to cost estimating of major capital budget items and the spending of approved project funds.
3) Contribute to the planning and execution of components of the development process, which apply to product revision or enhancement or a defined piece of a larger project.
4) Ability to manage routine small projects without assistance.
5) Investigate and analyze design improvement suggestions. Recommend design improvements.
6) Perform standard engineering assignments which are typically a significant portion of a larger project. Select sound techniques to solve problems and make design recommendations under direction of supervisor. Assess results for application, validity and conformance to specifications. Recommend material and process specifications.
2) Utilize engineering tools to solve straightforward problems (e.g., FMEA, Finite Element Analysis, Process Modeling, Design of Experiments, Mold Flow, SPC)
Qualification
1) Knowledge of the basic principles in various engineering disciplines.
2) Must have initial training in concepts of Six Sigma quality techniques.
3) Must know how to effectively run projects, coordinate contractors, and direct the activities of a technician
Education / Experience
Minimum requirement Bachelors of Science in Engineering (discipline: Mechanical, BioEngineer, Chemical Engineer, or etc.)
1 - 3 years experience of medical device experience
Statistical background helpful
Knowledge of DHF or DHF Remediation
Medical Device Product Life Cycle, Design Controls
Software: Microsoft Office: Word, Excel (pivot tables, V-looks), Outlook, PowerPoint; Minitab; DOORS; CAD
Interview Platform: phone •
Last updated on Oct 12, 2023