12 Month Contract (May extend or convert to perm)

4 days on site with 1 flex day – Standard 8am-5pm or 10am-7pm depending on flexibility

Top 3 skills sets required for this position:

• Operations experience
• Solidworks
• Root cause investigations

Main responsibilities/day to day activities required for this role:

• Work with operations on day-to-day issue resolution.
• Support quality issues such as nonconforming material requests
• Root cause investigation of critical issues.

Position Details:

• The Cardiac Ablation Solutions division in searching for a dynamic Mechanical Design Engineer II to join our growing team!
• The chosen candidate will be heavily involved in supporting the design work for a critical ablation program.
• Cardiac Ablation Solutions team is engaged in developing next generation medical technologies that save lives and improves the quality of living for millions of patients across the world.

Responsibilities may include the following and other duties may be assigned:

• Leads the design, development, and implementation of manufacturing line transfers.
• Accountable for supporting day-to-day requests from operations.
• Support nonconforming material requests for quality engineering by evaluating design impact.
• Identifies opportunities to improve and streamline quality and process improvement processes.
• Supports root cause investigations for manufacturing failures with cross-functional teams.
• Work with other engineers and technicians to execute experimental designs and analysis.
• Ensure execution of detailed engineering analyses & documentation to support design development and support process transfer.
• Assume responsibility as subject matter expert to represent organization as a design engineering contact for projects, process improvements, and quality events.
• Communicate effectively with cross-functional teams across multiple company sites to ensure alignment of bigger picture.
• Manage multiple high priority design requests.

Position Requirements:

• Degree in Mechanical or Biomedical Engineering with 2-5 years of relevant experience
• PC experience (MS Word, Excel, PowerPoint, MS Project, Outlook, etc.)
• Proven, hands on experience with lab testing and prototyping
• Experience with CAD software such as SolidWorks
• Effective and proven cross functional collaboration
• Demonstrated ability to apply statistical tools
• A good communicator and fluent in English, both in writing and speaking
• Knowledge and experience in engineering mechanics, mechanical design, and structure and properties of materials.
• Ability to research technologies, technical approaches, and relevant topics.
• Working knowledge of risk analysis including Failure Mode and Effects Analysis (FMEA)
• Experience with ISO 13485:2005, EU MDR, and QSR 21 CFR part 820
• Experience with finite element analysis (FEA) methods and software
• Knowledge of human anatomy and physiology.
• Experience working within a Product Development Process, preferably in the context of medical device development
• Experience with design of molded and machined parts.
• Experience with Geometric Dimensioning & Tolerancing (ASME Y14.5)