Senior Process Engineer II

5 days ago


Danvers, Massachusetts, United States The Chemical Engineer Full time
About the Role

We are seeking a highly skilled Senior Process Engineer II to join our team at The Chemical Engineer. As a key member of our engineering team, you will be responsible for leading early-stage design and process development projects for novel hemodynamic support devices and accessories.

Key Responsibilities
  • Lead initiatives with engineers in research, product development, new product introduction, and contract manufacturers or OEMs.
  • Collaborate to deliver designs with margin to performance requirements and demonstrated process capability in scalable manufacturing processes.
  • Serve as Subject Matter Expert (SME) across platforms and lifecycle phases from research through sustaining teams.
  • Conduct voice of the customer and transform clinical observations into new device concepts and requirements.
  • Generate intellectual property through invention disclosures in pursuit of patients and trade secrets.
  • Turn concepts into reality by rapidly prototyping using a variety of fabrication techniques.
  • Test and iterate on designs to develop optimal solutions.
  • Bring solutions to market by collaborating with an exceptional cross-functional team.
  • Conceptualize, design, prototype, procure, and build components and assemblies for products and testing/manufacturing fixtures.
  • Lead the planning and execution of animal and cadaver labs throughout the development cycle.
  • Conduct feasibility testing, analyze, and report on test results providing conclusions and recommendations.
  • Perform failure investigations in the event of test failures with support from the technical team.
Requirements
  • BS in Mechanical Engineering or directly related scientific discipline.
  • 8+ years of related experience in medical device, 4+ years in manufacturing or new product introduction.
  • Strong problem-solving skills and demonstrated experience identifying root cause of device failures.
  • Demonstrated ability to execute tasks in a timely manner under minimal supervision.
  • Willingness to learn the interventional cardiology space - the devices and the clinical practice.
  • Experience applying statistical techniques and analysis.
  • Willingness & ability to travel internationally ~5% of the time.
Preferred Qualifications
  • Experience in FDA Class II and III medical devices.
  • Experience in Solidworks 3D modeling, 2D drawing applying GD&T, PDM. Able to model complex parts and assemblies and conduct basic structural and fluid FEA.
  • Proficiency in scientific molding and other plastic processes including insert molding and complex engineered shafts.
  • Proficiency in laser-cutting, machining, coatings and finishing of metals and ceramics.
  • Experience in equipment and tooling design, fabrication, process development, and validation.
  • Hands-on experience in prototyping in pilot manufacturing and rapid prototyping; basic machine shop equipment.
  • Hands-on experience in testing in a laboratory environment.
  • Strong understanding of design control and risk management processes and deliverables.
  • Experience in design for manufacturing of plastic and metal components.
  • Strong understanding of statistical analysis of data, DOE's, DMAIC, DFSS, Six Sigma Green Belt+.


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